Table of contents Chapter 1 CORPORATE OVERVIEW Chapter 2 TECHNICAL EXPERTISE Chapter 3 DESIGN – PERTINENT EXPERIENCE Chapter 4 VALIDATION - PERTINENT EXPERIENCE Chapter 5 AUTOMATION AND INTEGRATION – PERTINENT EXPERIENCE Chapter 6 PROCESS ENGINEERING – PERTINENT EXPERIENCE Chapter 7 PROJECT FACT SHEETS

1. CORPORATE OVERVIEW

SNC-Lavalin Pharma (SLP) is a leading global engineering, procurement, construction, validation, compliance and related technical services organization serving the biotechnology and pharmaceutical industries, life sciences organizations and the institutional sector. SNC-Lavalin Pharma has a global responsibility for the Bio-Pharmaceutical sector within SNC-Lavalin Inc.

SNC-Lavalin Inc. (SLI) is one of the world’s largest groups of engineering and construction companies as well as a major player in the ownership of infrastructure and operating & maintenance services. With offices in 34 countries, SLI is currently working on projects in over 100 countries around the world. As one of SNC-Lavalin’s divisions, SNC-Lavalin Pharma is part of an integrated worldwide network of 18,000 highly qualified employees.

SNC-Lavalin Pharma offers services that meet the needs of the biopharmaceutical industry, which include the design, implementation and validation of projects involving research, manufacturing and support facilities. We offer these services from offices in Philadelphia, Montréal, Quebec, Toronto, Calgary, Brussels, Lyon and Mumbai, which represent an international network of over 700 specialists. These specialists have a solid base in engineering, validation and project execution and are capable of developing novel and creative leading edge solutions based on industry needs. These professionals are specialized in servicing the pharmaceutical and bio-technological companies and can provide the full spectrum of services from preliminary studies to process validation.

SNC-Lavalin Pharma has assembled a highly qualified and experienced group of resources represented in areas of major pharmaceutical and biotechnological activities. Growth has come from both organic growth and from partnering activities integrated into one industry-focused group. Using a flexible organization approach and virtual office systems, specialized resources from around the globe can be brought to bear to a project in any region. SLP is made up of the following members:

• LKM Engineers, Toronto and Sudbury, ON

• Pellemon, Montréal, QC

• Wiebe Forest Engineering, AB

• Sogequip, Lyon, France

• Coppée-Courtoy, Brussels, Belgium

• Pipecon Consultants Pvt., Mumbai

With the expertise of our qualified staff, many of whom have industry experience, we can tailor our services to ensure the satisfaction of our clients. In this context, and with the experience of our centres of excellence, we are well equipped to offer the following individual or integrated services:

• Process Architecture

• Facility Engineering

• Process Engineering

• Process Automation

• Design Visualization

• Robotics

• Validation & Compliance

• Project Management

• Procurement

• Construction Management

All SLP offices are linked through sophisticated information technologies, allowing a seamless transfer of documents and information. This ensures that the Project Team will have easy access to all required information wherever they are located.

1.1 SNC-LAVALIN PHARMA AND THE BIO-PHARMACEUTICAL INDUSTRY

SNC-Lavalin Pharma’s desire to be involved in biotech and pharmaceutical projects has its source in the fact that SNC-Lavalin Pharma’s engineers recognize that the needs of the pharmaceutical industry’s engineering systems are among the most challenging in terms of sophistication and complexity.

In order to maintain a leading edge in high tech building and process technologies, SNC-Lavalin Pharma recognizes its own need to invest in R&D in this field, as is the case for the pharmaceutical industry in its own fields of expertise. As a consequence, SNC-Lavalin Pharma is following in the footsteps of the pharmaceutical industry and has started what it considers to be a very innovative building technology R&D plan that revolves around two major poles:

− SNC-Lavalin Pharma’s role as founding partner in the Central Canada Chapter of the ISPE (International Society for Pharmaceutical Engineering).

− SNC-Lavalin Pharma’s role as founding partner in the Canadian Chapter of A3P (Association for Clean and Sterile Products, based in Europe).

− SNC-Lavalin Pharma’s role as an affiliate member of IRPI (Institute for Research in Industrial Pharmacy).

− Active participation of our staff in industry forums, technology-related panels and similar functions in life sciences sectors.

Through a very proactive presence in these organizations, SNC-Lavalin Pharma is significantly investing in terms of time, energy and financial resources and recoups solid technical training and a better global understanding of the pharmaceutical industry’s design and compliance needs and requirements.

As the pharmaceutical industry has clearly demonstrated in the past with its massive investment in R&D, SNC-Lavalin Pharma strongly feels that its future success and survival directly depend on these R&D efforts, in addition to creating strategic alliances with the pharmaceutical industry.

2. TECHNICAL EXPERTISE

For twenty years, SNC-Lavalin Pharma has carried out numerous projects for biotechnological and pharmaceutical industries as well as for hospitals and government agencies. These include R&D laboratories, manufacturing/production areas, in particular pertaining to solid dosage (granulation and compression), coating columns, fluid bed dryers, production of antibodies, solvent tank farms, liquid production lines, etc.

SNC-Lavalin Pharma has thus developed a dedicated team of specialists with current expertise in the process design, facility engineering and validation of the sophisticated systems usually required in such facilities.

These requirements reflect the industry’s needs to create, control and monitor, among others, the environmental parameters (temperature, humidity, pressure, ventilation, filtration) while ensuring the safety of researchers, operators and other workers as well as adequately confining associated chemical and biological contamination risks.

Our frequent and close collaboration with the engineering departments of our pharmaceutical and biotech clients has given SNC-Lavalin Pharma the opportunity to acquire a thorough understanding of the specific and challenging needs of research as well as production, in addition to the requirements of the authorities having jurisdiction (FDA cGMPs, TPP cGMPs and GLPs, Sanitary 3A, CSA, NFPA and FM/ULC).

This understanding has also included a very close collaboration, on a number of our mandates, with inspectors from the American FDA, the British MCA as well as from the Therapeutic Products Programme (TPP) of Health and Welfare Canada, for the validation of facilities, systems and equipment.

2.1 KNOWLEDGE OF APPLICABLE STANDARDS AND REGULATIONS

SNC-Lavalin Pharma’s expertise more particularly cover the standards usually applied to the design of pharmaceutical production and research centers and laboratories, including sterile facilities and injectable handling systems, which must be certified by the FDA and the TPP, as well as meeting the current good manufacturing practices standards (cGMPs) published by the Code of Federal Regulations (Chapter 21) for the United States and by Health and Welfare Canada. The interpretation of these GMPs, which are regularly published in the Code of Federal Regulations, is also of interest, as the standards are constantly updated in order to meet new industry requirements. The rapid evolution of the good laboratory practices (GLPs) applicable to research facilities’ activities is also very closely followed by SNC-Lavalin Pharma.

The members of SNC-Lavalin Pharma’s pharmaceutical and research facilities project teams are all well aware of the importance of proper interpretation of these standards and of their constant evolution due to the changing needs of the industry, but also to the availability of new technical solutions. This is why a constant effort is made by SNC-Lavalin Pharma to improve its level of awareness in this field; this is done by means which include technological transfers and training, including attending educational seminars set up by ISPE North America and European branches, as well as direct consultations with US-based experts specialized in the validation and certification of pharmaceutical systems.

Regulations regarding the confinement of biological hazards are also of utmost importance as they define several basic criteria to be met by electromechanical systems and important architectural elements of buildings where products with potentially high risks of biological contamination are handled. Policies concerning bio-safety in laboratories, as published by the Center for Biological Diseases of the US Department of Health and Human Services and the Laboratory Center for Disease Control of Health and Welfare Canada, strictly govern this matter. Similarly, the regulation published by the Atomic Energy Control Board (document R-52) states their guidelines concerning the handling of elementary and intermediate radioisotopes in a laboratory.

Our process automation personnel is bound by our internal procedures (our quality manual is available for on-site review) and these reflect, where relevant, ANSI/ISA-S88.01 and GAMP standards.

As for animal facilities, the standards and requirements stipulated by the Canadian Council on Animal Protection (Manuals on Care and Use of Animals for Experimentation, volumes 1 and 2) serve as reference.

2.2 THE SYSTEM LIFE CYCLE APPROACH

The System Life Cycle approach was developed by the biopharmaceutical industry in recent years. At SNC-Lavalin Pharma, we have developed our own version of the System Life Cycle (SLC) approach in the last few years and we continue to adapt it in order to better serve our biopharmaceutical clients.

The System Life Cycle breaks down the project into three majors phases, made up of a total of nine steps, which are common to all projects. The SLC involves not only the A/E firm but all the stakeholders for the project. In fact, even if SNC-Lavalin Pharma is not directly involved in all the steps of the SLC, we try to give the best input possible to our Client to ensure a smooth transition from one phase to the other.

The scheduling phase is split into three steps: an opportunity study, a feasibility study and a study of variables. It is during the scheduling phase that the major issues need to be discussed and resolved. Any major issues that are missed in this phase could have a significant impact on the financial or technical viability of the project.

The realization phase is split into four steps: basis of design, detailed design, procurement and construction. Obviously, this is where SNC-Lavalin Pharma has the biggest impact on the project and where we would put a lot of effort into guaranteeing the best A/E and CM services to our Client.

The operation phase is split into two steps: installation and operation. It is in this phase that some of the most critical steps of the validation are completed. The last step, operation, normally has no end point and is managed by our Client on a continuous basis.

2.3 KNOWLEDGE OF SPECIAL SYSTEMS AND ELEMENTS

SNC-Lavalin Pharma’s specialized expertise results in extensive familiarity with the standards and best practices used in the pharmaceutical industry for the following areas:

Layout planning

Special planning of corridors, loading and unloading docks, production, storage and packaging rooms and of their location, as well as the careful planning of doors and room access allows for the optimal use of areas for handling and circulation of raw material, semi-finished, finished and packaging materials, equipment and personnel, animal circulation (clean-dirty corridors concept) while meeting production needs and avoiding cross-contamination. Research facility characteristics also include a high level of M/E content thus creating a significant need for M/E equipment room areas, a higher floor-to-floor height, a lower building net to gross area ratio, and a need to coordinate locations of M/E rooms so as to limit the possibilities of effluent reingestion.

Process and Automation

When it comes to production skids, the scope of services for the design of process and automation engineering includes process flow diagrams (PFDs), piping and instrumentation drawings (P&IDs), general arrangement drawings (GAs), process equipment specifications (bid package, bid analysis and recommendations) and automation specifications (instruments, instrumentation and mechanical equipment index, control loop diagrams, layout drawings, installation details and interconnection drawings). Process and automation expertise in the pharmaceutical industry covers process skids, process utilities, environmental systems, and clean-in-place (CIP) systems. Process skids include solvent tank farms, aqueous and solvent solutions for coating and granulation, fluid bed dryers, coating columns, liquid production lines, packaging and filling lines, etc.

Process utilities include USP purified water, compressed air, nitrogen blanketing, process steam, clean steam, process air conditioning, hot and cold water, etc. Environmental systems include spill containment and waste solvent collection measures, measures against solvent vapour emissions, decontamination systems, etc.

Clean-in-place (CIP) systems include production, storage, distribution and recovery (and recycling) of cleaning solutions, from simple systems such as wash-in-place (WIP) to clean-in-place (CIP) and finally, sterilize- or steam-in-place (SIP).

The integration of liquid process services with process skids in the fixed furniture is also a key element for flexibility.

Water systems

Recognizing the acute need of the industry on this matter, SNC-Lavalin Pharma has acquired solid expertise in the design, construction and validation of water treatment systems and water distribution networks producing water-for-injection (WFI), USP purified water, and laboratory quality demineralized water, using a combination of multi-layer filtration, water softening, 5 micron filtration, chlorine removal, distillation or reverse osmosis process, deionization (mixed bed or continuous), U/V sterilization and final filtration to achieve both the chemical and the bacteriological water quality required by the client. The right selection of piping material, welding methods, network cleaning, jointing and erection methods, temperature conditions, minimum flow rates and velocity to be maintained for these networks are all parameters that must be controlled to achieve acceptable results.

Environment systems

Ventilation and air conditioning systems are designed to create a clean and/or aseptic environment, free of contamination, to meet the requirements of the industry and the applicable norms. Air filtration levels and the creation of clean rooms of classifications ranging from 100,000 to 100, using HEPA filters, are of the utmost importance to produce such an environment. In order to maintain the quality of this environment, the systems must be able to control and monitor the following parameters: room-to-room relative pressurization levels, air circulation flow rates, temperature and relative humidity. Essential requirements for validation and certification of these facilities are that all of the above parameters be recorded and documented.

Fume hoods and biological safety cabinets, and their arrangement in efficient systems capable of guaranteeing the scientists’ safety and health while ensuring an energy-efficient system, is a major issue in a state-of-the-art, energy-efficient research facility.

Dust control

The control of dust and particle emissions resulting from production processes requires the installation of dust recovery systems integrated into ventilation and air conditioning systems. This integration may be required to maintain the pressure at differential levels even when the dust collector systems are not in operation. House vacuum systems are also normally required for the periodical cleaning of equipment and of the rooms themselves.

Effluent treatment

Liquid and gaseous effluent treatment systems (such as neutralization, disinfection and filtration systems and kill tanks (sterilization)) are required by regulatory authorities (Environment bodies, municipalities) and codes and standards for the protection of the environment.

Room finishes

The quality of room finishes and the methods and details used for their construction, ease of maintenance and cleaning, i.e. no holes or cracks may be visible in the finish, and all surfaces must be sealed. These surfaces must be hard, smooth and free of sharp edges where dust could accumulate; all protruding elements in the rooms must be easily cleanable. The impact of these requirements on the visible elements of electromechanical systems must be considered in their selection, for proper integration into the overall building.

The high sealing efficiency of the partitions (walls, ceilings, floors) required to maintain the pressure differential rates needed between adjacent rooms has a direct impact on the selection of building, structural and architectural systems. Special sealing systems are sometimes required as a remedy to existing conditions.

Safety issues

The safety of scientists and other personnel is a very important aspect of the global design of research centers. Key elements include the following:

• location of means of egress for scientists with respect to the most probable sources of danger (solvent concentration, fume hoods, etc.);

• location of ventilated solvent storage cabinets; • fume hoods and biological safety cabinets; • eye wash and emergency shower water networks and locations; • solvent storage rooms and explosion venting; • high solvent content room partitions, explosion rating design and explosion

venting panels; • sprinkler and fire cabinet locations; • electrical classification (intrinsically safe systems, explosion-proof areas,

etc.); • HAZOP (hazardous operations, interlocking, emergency stops, etc.).

Access to electrical and automation systems

Easy access to electrical and automation systems and control elements for maintenance, calibration and replacement is a key element which must be considered in design. Explosion-proof rooms, types of ceilings, types of easy

cleaning access panels, and their integration into the buildings are all elements that require particular attention when designing these sophisticated facilities.

Flexibility

This word has a very special significance for pharmaceutical production and research facilities. With the fast-growing rate at which production and research can evolve, systems must be designed so that they can still meet the industry needs in the future.

Communication

Process and building communication networks for voice and data are now included in state-of-the-art research and manufacturing facilities.

Emergency and UPS

Emergency power supplies for research systems as well as for environmental systems are now more and more contemplated in research facilities and include static uninterruptible power supplies (UPS) for process automation.

Building control and monitoring systems for process automation

Recent computer technology combined with industry needs has dramatically changed the building control integration level in facilities.

SNC-Lavalin Pharma takes pride in the fact that all control and automation design for all above-listed systems is done in-house by SNC-Lavalin Pharma’s own team of control and building automation experts.

2.4 CONSTRUCTION MANAGEMENT/GENERAL CONTRACTING

As construction manager, SNC-Lavalin Pharma can become the Owner’s representative and manage all field construction activities. This includes responsibility for the construction methods, techniques, sequences, procedures, costs, schedules, quality and warranty of the construction work. To accomplish this construction work, SNC-Lavalin Pharma will bid and award contracts to pre-qualified and approved subcontractors for all segments of the work on a competitive bid basis.

SNC-Lavalin Pharma is directly accountable to our client for all construction and other items relating to the construction of the facility. During the construction phase of the project, we coordinate all activities to develop an orderly, controlled construction effort within the agreed time frame. Our capability in management, engineering, budgeting, cost estimating and control, scheduling, purchasing,

inspection and labor relations is fully utilized to ensure the successful achievement of the project objectives.

PM+ ® , SNC-Lavalin’s proven Project Management system, is a professional delivery service encompassing everything needed to plan, design and construct a facility with one source directly accountable to the client. The specific benefits of TPM are:

• Single-source responsibility • Reduced administrative burden • Early cost determination and control • Reduced financial risk • Schedule compression

Projects are managed by a single individual who has total project responsibility. This improves coordination and communication from project conception to completion. The Project Director is ultimately responsible for the delivery of all aspects of the project, and is the focal point for project information distribution throughout the assignment. This Director manages all project resources and facilitates communication between the client and the team of professionals.

PM+ ® allows the design and construction phases to operate as independent professional organizations; integrated through the Project Director and providing an optimum balance between design and construction considerations. Contractual options are tailored to the individual owner’s needs and ensure delivery within budget, schedule and quality requirements.

SNC-Lavalin Pharma’s ability to meet owner schedule and budget requirements is enhanced through our project management and reporting systems which provide our project managers with timely information.

2.5 CONSTRUCTION SUPERVISION, START-UP ASSISTANCE

The engineering construction scope of work includes bid packages (specifications, standards and drawings), construction management (construction work, schedule, supervision of process skid installation and shop drawing approval) and assistance upon start-up operations (training sessions, documentation required for IQ/OQ validation, automation system debugging and as-built drawings).

Construction work supervision is of prime importance, ensuring the optimum quality of facilities. A high level of sophistication of systems and finishes requires constant follow-up and monitoring, allowing good construction work progress and quality that meets specification requirements.

System start-up, balancing and calibration are essential parts of the project as they will allow subsequent installation, operation and performance qualifications (IQs, OQs, PQs) to take place, if required, as well as to gather required documentation for validation.

SNC-Lavalin Pharma’s team can provide on-site supervision as well as assistance upon system start-up.

Our recent experience in projects involving production and research centres shows the importance of the presence of the design team members on-site upon electrical and automation system start-up in order to be able to assist the various contractors break in the state-of-the-art systems.

2.6 QUALIFICATION AND VALIDATION

The preparation of documentation proving to regulatory agencies that the facility conforms to cGMPs is an important issue in the industry.

Every integrated validation process starts with the preparation and implementation of a validation master plan early on in the design phase; this plan carefully defines and documents all procedures and activities which have an impact on the process.

The preparation and early submittal of the validation master plan to authorities having jurisdiction (TPP and FDA) allows the Owner and the authorities to reach agreements in principle early in the project. It also allows design deficiencies to be detected and corrected.

To this end, close collaboration between the Owner’s representatives and SNC-Lavalin Pharma’s team is required in the elaboration of the validation master plan, IQs, OQs and PQs as well as Standard Operating Procedures (SOPs), and their integration as a whole into all other elements which form the overall plant master file (equipment data sheets, calibration procedures, preventive maintenance programs, change orders).

SNC-Lavalin Pharma is proud to offer the pharmaceutical industry a complete range of validation services for building and process systems.

3. PERTINENT EXPERIENCE – DESIGN

Total Cost Year

Genzyme Corporation New Biotech Production Facility, Lyon, France

$142 M 2010

Actavis Suite 3 Project N/A 2008

BD Diagnostics GeneOhm New Medical Device Research and Manufacturing Facility

$20 M 2008

Converted Organics First Biostimulant Production Facility – CM services

$14.5 M 2008

Wyeth Consumer Healthcare Renovation of Laboratories, Buildings 11 and 14

$8.5 M 2008

AstraZeneca Chemistry Labs Expansion, Montreal R&D Centre

$5 M 2007

G+G Partnership Architects New Toronto Centre for Phenogenomics (TCP)

$69 M 2007

GSK Biologicals SF Facility Production Upgrade N/A 2007

GSK Biologicals New Quality Control Laboratory, Belgium

∈120 M 2007

Guerbet, France Injectable Active Substance Facility ∈5 M 2007

Kasian Architecture University of Calgary – Child Development Centre (LEED Platinum Certifie )

$23 M 2007

Merial, France Monolayer III Project: Global basic design & process achievement engineering

∈30 M 2007

Novasep, France Biotechnology Facility ∈10 M 2007

OPP Forensic Facility CL3 (Containment) Lab Facility $1.1 M 2007

Sandoz Major Expansion - Sterile Production Plant

$40 M 2007

Sanofi Aventis, France New Warehouse ∈10 M 2007

Wyeth Research SmartLab 1 Upgrade, Building 5 $4M 2007

Biovail Steinbach Facility Expansion $27.5 M 2006

Total Cost Year

CNRC, Industrial Materials Institute

Nanofabrication Clean Room and Prototyping Centre Development

$3 M 2006

Flamel, France Micro-pump Pilot New Pharma Production Facility

∈20 M 2006

GSK Biologicals Expansion and Retrofit of QC, New Shipping fit-out and New Seed Preparation Areas

$51 M 2006

GSK Biologicals Expansion of Production Area (Option 5) – partial design services

$50 M 2006

NUCRYST Pharmaceuticals API Production Facility Renovation $2 M 2006

Pdi Pharma GLP & cGMP Facility for Pharmaceutical Testing (over 15,000 SF of R&D pharmaceutical labs)

$4.8 M 2006

Pfizer Consumer Healthcare New Global R&D Laboratory (relocation)

$3.2 M 2006

Roche Diagnostics Inc. Expansion of Existing Offices $6.5 M 2006

Sanofi Aventis, France Logistic Building Restructuring ∈10 M 2006

Sanofi Pasteur New Research Vivarium $18 M 2006

Taro Pharmaceuticals GLP Labs, Validated Production Facilities Infrastructure and Service Upgrades

$3.6 M 2006

Trent University DNA Cluster Project, including New BL3 Laboratory

$20 M 2006

AstraZeneca OAZis Cafeteria Extension at Montreal R&D Centre

$1 M 2005

Cephalon, France Pharmaceutical Chemical Unit ∈24 M 2005

Charles River Labs (previously CTBR)

Buildings 7 & 8 – Safety Assessment Lab Complex

$20 M 2005

Dermik Laboratories Lab and Office Renovation $1.7 M 2005

GSK Biologicals, Belgium Live Viral Vaccine Facility ∈44 M 2005

GSK Biologicals Renovations to Building 15, $13.5 M 2005

Total Cost Year

(recipient of Leonardo Award)

Nicholls Yallowega Belanger Architects

Northern Ontario School of Medicine – Northeast Campus

$17 M 2005

Pharmacy Faculty and IRIC Research Institute

New Pharmacy Faculty and new Immunovirology & Cancer Research Institute

$84 M 2005

Phyton Biotech Lab and Office Renovation $2.1 M 2005

Therakos Laboratory and Office Renovation $1.6 M 2005

Veterinary Medicine Faculty – St.Hyacinthe

Veterinary Medical Center and Institute of Veterinary and Food Biotechnology

$57 M 2005

Baxter Healthcare Equip Prep Area Sterile Facility $4.7 M 2004

Centocor Cell Banking Facility $4.7 M 2004

DSM Biologics LSE – Large Scale Expansion (Design completed, not built)

$140 M 2004

Lorus Therapeutics Clean Animal (Vivarium) Room Facility – FDA Approved

$1 M 2004

McMaster University DeGroote Centre – Centre for Molecular Medicine & Health

$65 M 2004

Novocol Phase 2 – New Bosch Filling Line $9 M 2004

Pfizer Manufacturing Renovation at Lilitz Facility

N/A 2004

Sanofi Aventis, France Cytotoxic Pilots (2 projects) ∈15 M 2004

AstraZeneca Utilities Upgrade $7 M 2003

Centocor 3000 SF GMP Pilot Plant $3.6 M 2003

Concordia University Loyola Science Faculty $64 M 2003

Hemosol HemolinkTM Commercial Production Facility

$57 M 2003

McGill University Montreal Genomics and Proteomics Center

$20 M 2003

Total Cost Year

MDS Nordion Kanata Radiopharmaceutical Manufacturing Facility

$30 M 2003

Merck Frosst Building 9-2 South Fit-out Project $10 M 2003

Merck Frosst Building 10 – North Extension $30 M 2003

Novex Pharma BFS / Compounding Upgrade $10 M 2003

Provincial Government Quebec Public Health Laboratory including BSL3 Lab

$10.2 M 2003

GSK Biologicals, Belgium Production, Filling & Packaging of Human Vaccines

∈8.8 M 2002

Hema-Quebec New Laboratories for Blood Processing Facilities

$19 M 2002

Novocol Sterilization & Plant Upgrade $2 M 2002

Sandoz Sterile Production Facility $4 M 2002

DSM Biologics ML-31/ML-51 Fit-out $7 M 2001

Merck Frosst Bldg 18 – Office building $35 M 2001

Merck Frosst Bldg 9 – 1st Floor Renovation $16 M 2001

Novocol Ph.1 – Sterilization & Plant Upgrade $2.8 M 2001

Valigen Renovation of 80,000 SF for a New Biotech R&D Facility

$9 M 2001

Charabot, France Raw Material Production Facility for Perfumes

∈11 M 2000

Johnson & Johnson Plant Expansion Project $19.6 M 2000

Merck Frosst Bldg 19 – PR & D Expansion $45 M 2000

Merck Frosst Bldg 9 – 2nd Floor Renovation $17 M 2000

Merck Frosst Bldg 9 – 2nd Floor Project – Research Administration

$4 M 2000

Merck Frosst Bldg 17 – New Quality Control Laboratory Facility

$12 M 2000

Novartis Interior Renovation Project $2.3 M 2000

Total Cost Year

Aeterna Laboratories New Biotech Production Plant $16.5 M 1999

Draximage Lyophilisation Extension $8 M 1999

Galderma Production Cream & Ointments Manufacturing and Packaging Facility

$22 M 1999

Laboratoires 3M Santé, France

Pharmaceutical Preparation Facility for Aerosol Production

∈18 M 1999

Merck Frosst Bldg 10 – Third Floor Fit-out $14 M 1999

Novartis Production Renovation & Additions $10 M 1999

Pfizer West Building $12 M 1999

Roberts Pharmaceuticals Design of New Sterile Manufacturing Facility for Liquids

$10 M 1999

Apotex Renovation of Laboratories $1 M 1998

Merck Frosst Production Area Modernization $83 M 1998

Astra Pharma Rommelag 321 Expansion $2 M 1998

Astra Pharma Liquid Preparation Expansion $0.6 M 1998

National Research Council Biotechnology Research Institute – Expansion

$20 M 1998

Genpharm Process Optimization $1.2 M 1998

Glaxo Wellcome Mepron Malarone Production $4.5 M 1998

Novartis Plant Upgrade $8 M 1998

Pasteur Mérieux Connaught Component Pertussis Program (CP) $13 M 1998

ProMetic Pharma Plant Renovation $5 M 1998

Canadian Red Cross Relocation of Transfusional Services Center

$2.5 M 1997

Connaught Labs BCG Facility $14 M 1997

Genpharm Inc. Process Engineering $1.2 M 1997

Glaxo Wellcome Inc. R&D and Manufacturing Facility $120 M 1997

GSK Biologicals (formerly Flu Vaccine Production Plant $22 M 1997

Total Cost Year

Biochem Pharma)

Martec Pharmaceutical Hormone Granulation $6 M 1997

McNeil Pharma HVAC Upgrade for Consumer Products Plant

$0.25 M 1997

Merck Frosst High Shear Mixer Facility $0.3 M 1997

Merck Frosst Building 9 - Small Scale GMP Facility

$1.2 M 1997

Nordion International HVAC Upgrade, Phase I $0.7 M 1997

Novartis Pharmaceutical Corporation

Modifications to Dorval and Whitby Plants

$0.2 M 1997

ProMetic Pharma Process Flow Diagrams $0.5 M 1997

Ratiopharm (formerly Technilab)

Upgrade of HVAC Systems $1.2 M 1997

Sanofi Aventis, France SAPHIR Project: Fine Chemical and Pharmaceutical Units

∈60 M 1997

Schering Evaluation of Purified Water, Pure Steam and WFI Systems

$0.25 M 1997

Astra Pharma Pharmaceutical Research Center $23 M 1996

Bio-Intermediair New Biotech Production and Research Center

$15 M 1996

Bristol-Myers Squibb Warehouse Expansion $2 M 1996

CHUL Biomedical Research Center $22.3 M 1996

MDS Nordion Radiopharmaceutical Wing - HVAC System Upgrade

$1 M 1996

Merck Frosst Prilosec Project $8 M 1996

Merck Frosst Clinical Packaging Area $5 M 1996

Pfizer Renovation of Aseptic Suite $5 M 1996

Pfizer CIP/SIP Process Automation $1 M 1996

Pfizer Dry Blending Unit $1 M 1996

Total Cost Year

ProMetic Pharma Sterile Production $0.5 M 1996

Wyeth-Ayerst Renovation of Analytical Chemistry Laboratory

$2 M 1996

Biotechnology Research Institute

FDA and HPB Compliance $3 M 1995

Bristol-Myers Squibb Renovation of Laboratories $10 M 1995

Confab-Biopharm, Algeria FDA Compliance $10 M 1995

Enfant-Jesus Hospital Neurobiology Research Center $10 M 1995

Glaxo New Research Facility, Laboratory, P&D, Pilot Plant

$40 M 1995

Merck Frosst Preparatory Laboratory $4 M 1995

Pharmascience Pilot Plant Renovation $0.5 M 1995

Royal Victoria Hospital New Animal Quarters (vivarium) $3.1 M 1995

UCB Farchim, Switzerland Active Substance Production Facility for Pharmaceutical Product

∈6 M 1995

Pfizer, France Research Center Extension N/A 1993

Upjohn Pfizer Valdepharm, France

Pharmaceutical chemical unit ∈32 M 1992

Finorga, France Revamping of a chemical pharmaceutical facility

∈20 M 1992

Janssen Pharmaceutica, France

Pharmaceutical unit (pill coating) ∈6 M 1990

Pfizer, France Organic synthesis facility ∈15 M 1989

4. PERTINENT EXPERIENCE – VALIDATION

Client Project Year

Abbott Montréal, Quebec

Provided assistance to the validation department for various projects:

• Preparation and execution of protocols for the facilities

• Qualification of utilities for equipment, including medical gas

• Equipment qualification, including tray packers

• Pre-project engineering studies • Review existing validation protocols

and follow-up of Change Control program.

2002-2003

Andlauer Transportation Services (ATS) Inc. Montréal, Quebec

Validation and Qualification of the Laval Warehouse. Scope of qualification included empty and loaded temperature mapping of warehouse.

2006-2007

cGMP Design Review and System Qualification for designated GMP Distribution Warehouse.

2004-2005

Andlauer Transportation Services (ATS) Inc. Toronto, Ontario

Development of the Corporate Validation Master Plan for GMP and related temperature controlled distribution services.

Additional compliance services also included: • cGMP training and Good

Documentation Practices training • cGMP review of internal distribution

and handling processes • cGMP review of local SOP’s

2004

AstraZeneca Canada Inc. Mississauga, Ontario

Ventilator Autoclave System Qualification 2001

Validation of the Blow/Fill/Seal Production Department expansion, including preparation of the Validation Project Plan; preparation and execution of protocols for the BFS Filling Equipment and Finishing Line, On-Line Leak Detectors, Blister Pack Equipment, Autoclaves, Facility, Facility Monitoring System; HVAC,WFI, Medical Gas and Pure Steam Modifications

1999

Client Project Year

Validation of the Expansion of the Liquid Preparation area, including preparation of the Validation Project Plan; preparation and execution of validation protocols for the Facility, New Tanks, Automation and CIP systems; HVAC, WFI, Medical Gas and Pure Steam Modifications; preparation of SOPs for the CIP system and New Tanks.

Protocol preparation and execution. System Qualification(s) of 53’ temperature controlled transportation trailers including IQ/OQ/PQ with focus on monitoring and control system controls, empty chamber and loaded chamber temperature mapping studies.

2004

Client Project Year

Aventis Pasteur Ltd. Toronto, Ontario (Ongoing Long Term Partnership since 1997)

B93 - Qualification of the Formulation, Filling and Freeze Drying Equipment. IQ/OQ/PQ Validation activities, Cycle Development & SOP Preparation for:

• Freeze Dryer • Filler/Capper/Stopper Machine • Isolators

Site Part 11 Remediation of Excel spreadsheets and/or other analytical software for the integration to a New Data Repository System - for fifteen (15) systems:

• Creation of User Access Forms for creating new User Access Groups, addition of existing users to these User Access Groups and the modification of network folder file permissions.

• Create specification documents for those systems. Including affected areas such as Data Storage and Retrieval, Security Design, and Archive Capabilities.

Site R&D – Part 11 Remediation Services: • Collect information on the use of

various systems for preparation of User and Functional Requirement Specifications.

• Prepare and execute the Qualification Protocols and prepare final reports.

• Provide user training on the updated SOPs on changes made through remediation of the system.

B53 Suite 2 Facility Monitoring System – PQ Validation activities

Ongoing

Various Buildings (AvP Site) – 8 WFI Control Panel utility upgrades – IQ/OQ validation services.

B93 HVAC Cross Contamination Study – Multi Product Facility requiring dedicated segregation between facilities.

2003

Client Project Year

HVAC PQ / Environmental Monitoring Qualification.

Autoclave Revalidation IQ, OQ, PQ & Cycle Development.

Qualification of On line TOC Analyzers.

Compressed Air – On Line Air Drier Qualification.

Medical Gases – Nitrogen, Oxygen and Compressed Air – including P&ID Development, FRS Preparation, IQ, OQ, and PQ.

2002

Qualification of RSV Purification and Formulation process equipment, including a 20L, 200L, three 2000L Bioreactors, Harvester, Media Tanks, Centrifuge, two CIP Skids, 2 HVAC Systems, and Building and Process Computer Monitoring Systems.

Qualification of several HVAC Systems, including Environmental Monitoring.

2001

New Research & Development Facility - preparation of the Validation Master Plan; preparation and execution of the Validation protocols and preparation of the applicable PM and Operational SOPs for various systems and equipment.

Preparation of the PM and Operational SOPs for various systems and equipment for the Component Pertussis Manufacturing Facility.

Preparation of SOPs for the Maintenance Department for specific maintenance policies and the PM SOPs for various systems and equipment.

Validation of the Facility Monitoring System for the BCG and Hepatitis-A Manufacturing Facility.

Validation of the Facility Monitoring System for the Polio Manufacturing Facility.

2000

Research & Development Building – Validation of the Lyophilizer, HVAC system, Fermenter

1999

Client Project Year

and Filler.

Bacterials – HVAC Qualification.

Primary Production Measles – HVAC/ Duct Blowers Qualification.

Sterility Test – HVAC Validation.

1999

Cleaning Validation for various departments, data analysis and preparation of final reports.

1998

Validation of the Filling and Packaging Department, including preparation of applicable SOPs and Process Development for the Autoclaves.

Validation of the Material Distribution Centre, including the preparation of applicable SOPs.

Validation of the WFI System for the Operations Building, including the preparation of applicable SOPs and the Validation Master Plan Addendum.

1997

Aventis Pasteur Swiftwater, PA, (USA)

Validation and Non-Strategic Project Support

• Scope of services include providing an integrated on site Validation Group (6-10 personnel including a Site Project Manager) capable of executing on-going validation projects for a 1 – 2 year period. The SLP team is multi-disciplinary and specialized in various equipment / systems and services specific to this site.

Ongoing

FAT and SAT Commissioning coordination and execution review and witness for 2 new Large Scale Production Autoclaves. Preparation and Execution of IQ, OQ, PQ protocols , as well as Worst Case Assessment, Cycle Development, and equivalency studies for over 500 Load Items categorized within 5 Load Types.

2002-2004

Preparation and Execution of IQ, OQ, PQ protocols , as well as Worst Case Assessment and Cycle Development for 2 existing large scale production Autoclaves, and 1 large scale

Client Project Year

production Depyrogenation Ovens.

Various validation projects including system troubleshooting, various Process Validation assistance, Report Writing and Data Analysis and AvP Site Validation Guideline Development.

Banner Pharmacaps Olds, Alberta

GMP and QC training 2004

Validation of the Production and Containment Facility, HVAC, BAS, Vacuum, Steam, Drying rooms, BMS and Water systems

1998 to 2000

Bayer Diagnostics Mishawaka, Indiana, USA

Development of OQ protocols for functional testing of packaging equipment using PLC ladder logic to force permissive bit for path analysis and machine interaction verification. Programming platforms used were RSLogix 500, RSView 32, MachineShop, and 505 Workshop

2003

Bio-Intermediair Inc. Montréal, Quebec

Clean Utilities Validation for a new Bio-pharmaceutical Research & Development Facility – Purified Water, WFI and Clean Steam systems

Process and Cleaning Validation

Design of processes for the production of antibodies using fermentation and purification processes for components or products resulting from bacterial fermentation

1996

Biomatrix Montréal, Quebec

Process and Utility Validation of the entire plant 1998

Bristol-Myers Squibb Medical Imaging Dorval, Quebec, (Quebec) Mississauga, Hamilton, (Ontario), Vancouver (BC)

Conformity audit of systems linked with to engineering group to propose ventilation and laboratory environment improvements

Validation of clean room ventilation systems

2006

Bristol-Myers Squibb Candiac, Quebec

Various projects including:

Validation of process equipment

Validation of HVAC, clean steam, nitrogen systems

2002-2007

Client Project Year

Change control, SOP writing

Engineering and maintenance department support

Various projects including:

Construction and validation of the Clinical Supplies Operation Building, anti-tumor facility

Validation of lyophilizer, dry heat oven and autoclaves

Qualification for modifications of clean rooms and pure steam system

Construction and validation of the Clinical Supplies Operation Building, Packaging and labeling facility

Validation of the compressed air system, vacuum system, dust collector system, HVAC systems, nitrogen system, and Building Automation System

2001-2003

2002

Construction and validation of the Clinical Supplies Operation Building, manufacturing facility

Validation of a new clean compressed air system and a new house vacuum system

1999

Brunet-Graillon Pharmacy Gatineau, Quebec

Validation of clean rooms

Validation of ventilation systems

Writing laboratory procedures for operation and Quality Assurance

2006

Canadian Blood Services Various locations throughout Canada

Validation Projects for various systems and equipment including:

Development of Corporate VMP.

Development of specific Site VPP.

Development of standard protocol templates for Ultra Low Freezers, Freezers, Refrigerators, Incubators, Dry Block Heaters, COBE Spectra Apheresis Unit for global site use.

Development of URS and FRS for COBE Spectra Apheresis Unit.

Ongoing Long Term Partnership since 2000

Client Project Year

Development of URS templates for Freezers, Refrigerators, Incubators, Agitators, Centrifuges, Plate Readers, Cryobaths, Biohazzard Hoods, Fume Hoods, Dead Air Boxes, Sonicators, Water Baths, Plate Washers, Bag Sealers, Gamma Cell, Haemonetics PC S2, Olympus PK 7100/7200, Cell Processor.

Facility Commissioning / Qualification including HVAC, Fire Suppression, Back-Up Electrical and Site Security System.

Qualification of Ultra Low Freezers, Freezers, Refrigerators, Incubators, Centrifuges and Cell Washers.

Cangene Corporation Winnipeg, Manitoba

Expansion of a Biotechnology Manufacturing Facility Site. Preparation and execution of Validation Protocols for various systems and equipment, including:

• cGMP Sterilization Autoclave • Decontamination Autoclave • Bioreactors • Biosafety Cabinets and Laminar Flow

Hoods • Centrifuges • Clean Steam System • Compressed Air Delivery System • CO2 Delivery System • Nitrogen Delivery System • Oxygen Delivery System • Switch-Over Manifold for Medical

Gases • Coolers • Drying Oven • HVAC Systems • Filter Integrity Tester • Controlled Rate Freezers • CO2 Incubators • Chilled Water Recirculators • Hydrogen Peroxide Vapour Generator • Isolator • Vacuum Jacket Liquid Nitrogen

Network • Liquid Nitrogen Storage Tanks • Vacuum Pump and Network

2004

Client Project Year

• Water Baths • Purified Water System

New Biotechnology Manufacturing Facility. Preparation of protocols and supervision of Cangene team during protocol execution of process equipment, including:

• Bioreactors • Centrifuges • cGMP Sterilization Autoclave • Decontamination Autoclave • WFI, Pure Steam • Biosafety Cabinets, Fume Hoods, and

Laminar Flow Hoods • Media preparation • SCADA • HVAC and BMS

2002

New Biotechnology Manufacturing Facility Site Validation. Preparation and execution of Validation Protocols for various systems and equipment, including utilities, reactors, CIP Skids, Delta V Automated Monitoring & Control System

2001

Centocor, Inc. Malvern, PA, USA

Development of Technology Transfer Master Plan

2002

CIBA Vision Mississauga, Ontario

Analysis and revision of all IT SOPs

Validation of the Laboratory Management System

Site Validation Master Plan, Equipment Validation Master Plan, Process Validation Master Plan, and Computer Systems Validation Master Plan document preparation and approach development.

IQ/OQ/PQ Equipment, Process and Cleaning Validation Activities for various equipment including HVAC, Purified Water Systems, Purified Steam System, Medical Gases, Tanks, Pumps, Autoclaves, Filling and Packaging Equipment.

Bulk Product Sterilization - Cycle Development and Worst Case assessment for approximately

2004

Ongoing

since 2003

Client Project Year

30-40 product types.

Confab St-Hubert, Quebec

Audit of an ERP JDEdwards system

Training and support for an FDA inspection

Ongoing

Contract Pharmaceuticals Mississauga, Ontario

Equipment Qualification –preparation and execution of IQ/OQ protocols for the Manufacturing tanks, Homogenizers, Pumps, Mixers, Liquid Fillers, Bottle Unscramblers and Plastic Tube Fillers

1999

CV Technologies Edmonton, Alberta

Quality assurance system assessment of the potential vendor/supplier

Ongoing

Dermolab Ste-Julie, Quebec

Validation of 3 ventilation systems, thermopump and compressed air system (IQ/OQ/PQ)

2004

Draximage Montréal, Quebec

Process Validation 1999

Draxis Pharma Inc. Montréal, Quebec

Development of a terminal steam sterilization cycle

Validation of the production autoclave control system following program upgrade

2005

Validation projects for various systems and equipment including:

• Qualification of a large-scale lyophilizer (including CIP/SIP capabilities) and automatic vials Loading/Unloading system

• Autoclaves (2 units) and drying ovens (2 units).

• Autoclave cycle development • HVACs, Laminar flow Hoods and

dispensing booths. • SOP writing/training for many different

systems and equipment. • Validation of Computerized systems. • Qualification of packaging equipment. • Qualification of a Pure Steam system

and nitrogen system. • Qualification of container washing

machines, filling / stoppering / capping machines, and manufacturing

2003-2004

Client Project Year

equipment.

DSM Biologics Montréal, Quebec

Compliance Upgrade Project to modify existing Quality Systems for an existing Biotechnology facility. Services includes Training Program and SOPs Program.

Validated equipment and systems: • Bioreactors • Media Prep. • Computer validation • SCADA and BMS • Maximo.

Personnel loan for QE department of replacement of their QA Manager and involvement on QC tasks.

2004

Large Scale Expansion Project for a new facility for contract manufacturing of BL-1 monoclonal antibodies and recombinant proteins by cell culture. The facility will be mainly used for the production of Phase III and commercial drug active ingredients. Validation services included the following:

• Preparation and coordination of the User Requirement Specifications

• Preparation and completion of the Enhanced Design Review Process

• Review and coordination of Functional Specifications

• Preparation and completion of a FAT and SAT template

2003-2004

These services were provided for the following systems:

Upstream Process Equipment: Seed Bioreactor & PLC 30 L, Seed Bioreactor & PLC 150 L Seed Bioreactor & PLC 750 L Seed Bioreactor & PLC 3000 L Production Bioreactors & PLCs 12 500 L Feed Tank 2500 L Feed Media Addition Tank 4000 L Bioreactors CIP & PLC Process Tanks

Client Project Year

Process Tank PLC’s 4 Media Preparation Tanks & PLC Centrifuge & PLC Ultrafiltration & PLC Detergent holding / Distribution CIP Skids & PLC’s Process Transfer Piping

Downstream Process Equipment: DSP Pre-Virus Chromatography Skid & PLC DSP Pre-Virus Chromatography Column Pre-Virus Packing Station & PLC DSP Post-Virus Chromatography Skids & PLC DSP Post-Virus Chromatography Column DSP Post-virus Packing Station & PLC DSP Post-virus TFF Ultrafiltration Dead-end Filtration Buffer Preparation Tanks & PLC & Small Buffer Preparation and Acid-Base Tanks Buffer Holding Tanks &PLC Caustic (NaOH) Tank & PLC

Facility Utilities: HVAC Systems Emergency Power Building Automation Systems Walk-in Refrigerator/Freezer Clean Utilities: Pure Steam Generator Clean Air Compressors WFI System Decontamination & Neutralization & Process Drainage System & CIP Medical Gases (O2, N2, CO2)

Supporting Equipment: GMP Autoclave Decontamination Autoclave Double Door Washer Laminar Air Flow Hoods Bio- Safety Cabinets Incubators

Client Project Year

Liquid Nitrogen Cell Bank Freezers Fast Freezer Refrigerator / Freezer Chemical Fume Hoods

Process Control System: Engineering Workstation Security and Historian Backup Server Historian and Trending Server SCADA Server – Train No. 2 Batch Management Server I/O Directory Server Network Server Room Process Control Supervisory System Process Transfers CIP Transfer Security Access Cards

Several Validation Projects for various systems and equipment, including: compressed air, nitrogen, steam, BAS, purified water, WFI, softened water and equipment process skid, incubator, still

2000

Eli Lilly Puerto Rico

Computer Validation of a SCADA system 2005

Eli Lilly Indianapolis, IN, (USA)

Validation of a custom developed LIM System

Preparation for a FDA Inspection

2003

2001

Eli Lilly Toronto, Ontario

Validation of a Building Monitoring System

Completed

Ethypharm Laval, Quebec

Ensured full compliance with regulatory agencies, MCA & FDA for two facilities. This included:

• Prepare and perform internal audits • Revise the documentation related to the

QA system • Evaluate the validation status of the

systems and equipment • Preparation of the Validation Master

Plan for the Laval site and the site in France

2002

Client Project Year

Ethypharm Mumbai, India

QC revision and audit to conform to European GMP

2003

Ethypharm Chateauneuf-en-thymerais, France

GMP training 2003

Ethypharm Grand Quevilly, France

New FDA Audit

Two Compliance experts on site for18 months. This included:

• Perform Pre-inspection audit FDA and EU

• Support internal QA and optimization of procedures

2002, 2004

2001-2003

E-Z-EM Montréal, Quebec

Regulatory affairs support 2006

Federa/ Cardinal Health Brussels, Belgium

Validation leader of the new NOH Filling Facility in Brussels including:

• Water system • Ventilation systems • Processing equipments • Cleaning validation • Computer validation

Production department leader Documentation training

2006

Validation of laboratory equipment:

• Particle counter and software • Chromatograph • HPLC and software • Spectro UV and software • TOC and software • Automatic titrator • Mass spectrometer • Insulators • Insulator sterilizer

Production files optimization and support Site Master File Validation

2004

Galderma Production Montréal, Quebec

Various projects including:

• Cleaning Validation, Cleaning matrix

• Process Validation

2005-2006

Client Project Year

Various Projects including:

• Validation of the Production Skids; Validation of the Temperature Control Room

• Plant and Process Qualification • Preparation of SOPs

1999

Gambro Montréal, Quebec

Conformity and process support for a medical device company

2005

Genpharm Inc. Etobicoke, Ontario

Various projects including:

Packaging Line & Manufacturing Equipment Validation for a Solid-Dosage Manufacturing facility

Preparation of IQ/OQ/PQ protocol for compressed air systems

Qualification of vaults and security system used in storing controlled drugs

Preparation of two (2) Validation Master Plans: for Manufacturing Equipment/Systems and for Utilities Systems

Autoclave Validation

2001

GlaxoSmithKline Ste-Foy, Quebec

Validation of various systems, utilities and equipment for a Biotechnology Manufacturing Facility to conform to BSL2+

Validation of systems and equipment for the Seed Preparation and QC laboratory to conform to BSL2+

Validation of air units to conform to BSL2+

Validation of systems, utilities and production/process equipment for production capacity increase conform to BSL2+

Project coordination of all stages from the end of construction to completion of validation on behalf of the client, for the BSL2+ upgrade and production capacity increase

2006-2007

Cleaning Validation of process equipment, CIP system

2005-2006

Client Project Year

Validation of process equipments and systems

Computer related system (CRS) assessment

Commissioning of various utility systems

Project coordination for the installation, commissioning and validation of various utility skids

Preparation and execution of IQ/OQ/PQ and SOPs for various systems and equipment for a Biotechnology Manufacturing Facility:

• Laboratory, Manufacturing and Packaging equipment (fillers, stoppers, cappers, Inoculators, Harvester, Transfer Panels, Centrifuges, Inactivation UV systems, Autoclaves, Incubators, Refrigerators, Laminar Air flow hoods)

• Qualification of several utility systems, (HVAC, Clean Compressed Air, USP Water, and Pure Steam)

• Qualification of environmental monitoring program

• Qualification of the Central Archiving System related to process equipment monitoring.

Documentation review for the QA department

2003-2004

GlaxoSmithKline Laval, Quebec

Commissioning and Validation of Quality Control equipments and HVAC systems to conform to BSL2+

Cleaning validation

LV-01 (Bldg 15) (2006):

Validation of HVAC and process equipment to conform to BSL2+ (2006)

Cleaning Validation

LV-02 (R&D Environment) (2007):

Validation of HVAC in a BL-3 environment, of a purified water system

Writing of a Validation Master Plan for a BL-3 environment

2006-2007

Client Project Year

Validation of New Building 15; EPCMV project

Building upgrade; Addition to the ventilation systems and purified water system

Commissioning and Validation of process equipment and utilities

2005

Preparation and execution of Commissioning protocols, IQ/OQ/PQ and SOPs for various systems and equipment for a Biotechnology Manufacturing Facility:

• Laboratory, Manufacturing and Packaging equipment (fillers, stoppers, cappers, Inoculators, Harvester, Transfer Panels, Centrifuges, Inactivation UV systems, Autoclaves, Incubators, Refrigerators, Laminar Air flow hoods)

• Qualification of several utility systems, (HVAC, Clean Compressed Air, USP Water, and Pure Steam)

• Qualification of environmental monitoring program

• Qualification of the Central Archiving System related to process equipment monitoring.

Documentation review for the QA department

2003-2004

GlaxoSmithKLine Hamilton, US

Assessment, preparation of a remediation plan and implement the remediation plan of computerized systems.

Existing computerized system SOPs upgrade to meet new corporate requirements.

Validation assistance for the Engineering department to complete validation activities and document and resolve pending validation deviations.

2006 - 2007

Client Project Year

GlaxoSmithKline Biologicals (WN-128) Wavre Nord, Belgium

EPCMV of a new building

Writing of commissioning documents and the writing and execution of validation protocols, including:

• HVAC systems for laboratories (41 systems including BL-2 and BL-3), cold rooms (20 units) and incubators

• Bench LAF, Pass-Boxes, Process Tanks • Utility Systems (Process compressed

air, Process steam generator and distribution circuit, CEC – decontamination station, EDI – demineralised water, EPI – industrial clean water, CIP, SIP)

• PEMS – Process Environmental Monitoring System

• Washing machines (2 items) • Sterile autoclaves (4items) • Decontamination autoclaves (8 items)

2005-2006

GlaxoSmithKLine Biologicals (WN-119) Belgium

Validation of process services, clean building utilities, vaccine production

2004

GlaxoWellcome Mississauga, Ontario

Design Qualification Summary and Review of the USP Water System for the Mepron & Malarone Manufacturing Suite

1998

Héma-Québec Montréal, Quebec

Preparation of a validation master plan 2003

Hemosol Inc. Mississauga, Ontario

Validation services for a new commercial facility to manufacture a blood product extracted from expired human blood. Services include the preparation of the VMP; preparation and execution of DQ/IQ/OQ/PQ protocols for:

• Customized process equipment skids • SCADA • Customized software systems • Network infrastructure • Utilities including several HVAC

systems, Compressed Air system, Medical Gases (Nitrogen & Oxygen) Systems, WFI, Clean Steam System, Purified Water System

2000-2003

Client Project Year

• Building Automation System • Autoclaves

Hemosol Inc. Toronto, Ontario

Review of existing critical utility systems and the applicable documents in preparation for a Pre-approval Inspection.

Validation services for the Scale-up Plant, including the preparation and execution of IQ/OQ/PQ protocols, preparation of SOPs and Process & Cleaning validation for the associated systems, equipment and processes.

2001

Homeodel Montréal, Quebec

Conformity Audit

Regulatory affairs support

Training on GMP for natural and health products

Ongoing

Intelligene Expressions Inc. Edmonton, Alberta

New Fermentation Plant 1998

Johnson & Johnson Medical Products Markham, Ontario

Walk-in Cooler Validation – preparation and execution of IQ/OQ protocol, including empty chamber and loaded chamber temperature mapping, data analysis and final report

2000

Preparation of the required documents for the Qualification of the Distribution Warehouse Temperature Control

1999

JSS Medical Research Montréal, Quebec

Conformity Audit

Training on the validation lifecycle: development of URS, FS, DS, Programming Standards, IQ, OQ, execution of IQ and OQ.

2006

Providing support to achieve compliance to their site’s quality assurance system with applicable regulations.

Project scope of services includes:

• Giving training sessions to update JSS personnel on computer validation and 21 CFR 11 basic requirement, Good Clinical Practices, and Good Documentation Practices.

• Writing of a Quality Master Plan

2004

Client Project Year

• Support for computer system and computer validation

• Support for Quality Assurance

Knowlton Packaging Knowlton, Quebec

Conformity Audit in microbiology

Computer Validation Master Plan and Assessment of an ERP system

Ongoing

Labopharm Laval, Quebec

Validation of pilot production equipment in the laboratories for:

• Press Stokes 560 (#PRE-04) • Metal detector device in tablets • De-duster

2006

Validation of pilot production equipment in the laboratories for:

• Korsch Tablet Press • Korsch Compression Research System

– Computer Interface • Glatt Fluid Bed Dryer • Vector Laboratory Development

Coating System • Pk Blend Master V-Blender • Single Stroke Stokes F4 Tablet Press –

Powder Compacting Press • Quadro Comil • Glatt High Shear Mixer • Manesty Drycota 23 Station • Cap Seal Jr. Induction Heating

Generator

2004

LBVA-Veterinary and Food Biotechnology Laboratory, Faculty of Veterinary Medicine, Université de Montréal St-Hyacinthe, Quebec

New Biotechnology Manufacturing Facility Site.

Preparation of a compliance report and presentation to the applicable regulatory agencies of Canada and USA.

Preparation of various Standard Operation Procedures for systems, equipment and programs

2003-2007

Preparation of the Site Validation Master Plan, preparation and execution of Validation

Client Project Year

Protocols for various systems and equipment, including:

• Building Automation System (BAS) • Classified clean rooms • HVAC Systems • USP Purified water • Pure steam • Water For Injection • Clean compressed air • Medical gases: CO2 • Medical gases: N2 • Medical gases: O2 • Biological safety cabinets • CO2 and standard Incubators • Fermenters • Refrigerators • Freezers • Pumps • Sterilizing autoclave • Glassware washer • Freeze dryer • Process tanks • Transfer pump • 4°C room/quarantine

Les Laboratoires Aeterna Sainte-Foy, Quebec

Validation of the HVAC system and utilities in the Manufacturing Plant

1999

Les Laboratoires Riva inc. Blainville, Quebec

EPCMV (Engineering, Procurement, Construction Management, Validation) of a new USP purified water system – IQ/OQ, PQ

2005

Malinckrodt (USA)

Validation of Process Equipment 1997

Margo Inc. Division of the Alcan Group Jamesburg, NJ & Bethlehem, Pennsylvania

Validation of filling and packaging equipment including protocol preparation and execution:

• Tube Fillers • Autoclave, including Operation &

Maintenance SOP Validation services for a new contract packaging facility including preparation of:

• Validation /Cleaning Master Plan • Facility validation protocols IQ/OQ/PQ

2002

Client Project Year

for: HVAC, CA, BAS, Vacuum • SOPs for HVAC, CA, BAS, Change

Control • SOPs for the Validation approach,

Computer system periodic review, Security of computer system and back-up and recovery

Martec Pharmaceutical USA

Validation of a New Solid Dosage Production Facility, including the preparation of the Validation Master Plan; the Presentation of the VMP to the FDA authorities; preparation of the applicable Operation, Maintenance, Cleaning and Calibration SOPs; and validation of various Pilot Plant equipment

1996

Martec Scientific (USA)

Process Equipment Validation 1997

McNeil Consumer Products Guelph, Ontario

Consumer Products Facility - Validation of the HVAC and Building Automation systems and Incubator Mappings

1997

MDS Nordion Inc. Kanata, Ontario (Long Term Partnership from 1997-2003)

Preparation of the KRMF Phase 2 VMP, VPPs (Facility, Component Preparatory Room and Paragon Manufacturing) and Facility Commissioning Master Plan.

Qualification of the Component Prep WFI system, DI system, Particle Monitoring System, Autoclave, VHP unit, Vial Washer, Glassware Washer, Stopper Processor and Bag Sealer.

Facility Qualification including HVAC, BAS, Architecture, Clean rooms and medical gases.

Project Management for the Validation and Compliance activities required to achieve FDA approval for a Radiopharmaceutical Cancer Therapy.

2003

Preparation and delivery of a Training Session on the GAMP 4, including CFR 21 Part 11 Compliance Update.

Preparation of protocols and SOP for the qualification of a Vaporized Hydrogen Peroxide insert.

2002

Client Project Year

Documentation Review of Processes and Equipment for GMP and adherence to Validation Guidelines, for mechanical systems, production and QC testing equipment used in the manufacturing and testing of radio-pharmaceutical products.

Project Management for the validation and compliance activities required to achieve FDA approval for a Radiopharmaceutical Cancer Therapy.

Validation of the Manufacturing Operation of isotopes for Radiopharmaceutical applications – preparation of protocols and the review of documents for various systems and equipment.

2000

MDS Pharma Services Mississauga, Ontario

Validation of a Clinical Trial Database System

Various Computer Validation projects, which include:

• Compliance Audit for Clinical Trial Database System

• Preparation of report detailing remediation activities for the database system

• Preparation of Test Plans for customized interfaces

• Preparation and execution of Test Scripts for customized interfaces

2006

2003

MDS Pharma Services St-Laurent, Quebec

Development of a management system for the revision of 5 years of clinical studies results and information

Computer Validation (PQ software system)

2006

Medicago Ste-Foy, Quebec

Training on validation

Conformity Audit

Validation and commissioning of HVAC system

2006

Merck Frosst Canada Montréal, Quebec

Validation of laboratory equipment: Karl Fisher Titrator

2002

Compressed Air Renovation Qualification 2000

Various Projects, including: • Qualification of the Quality Operation

1999

Client Project Year

(QO) Building • QO Building - Autoclave and Incubator

Qualification • Training Documentation for the QO

Facility • Track 3 – Qualification of the USP

Water System • Mogensen Sizer Qualification; Kady

Mill Qualification

Building 2 – Building Automation System Process Equipment Qualification

QO Building – BAS Qualification Preparation of the Standard Validation Format for the BAS system

1998

Cold Room Distribution Centre Lot 3

BAS Qualification – Phases I and II

Lot 4 – Vacuum and Drainage Systems

1997

Validation of the Clinical Supplies Packaging Building, including the preparation of the Validation Master Plan and preparation of applicable SOPs

1996

Pilot Plant, Clinical Production 1993

Merck Sharp & Dome (South Africa)

Packaging Plant Validation 2000

Methapharm Brantford, Ontario

Validation services for the qualification of the new Glovebox and the Powder Filling System

2003

Novartis Pharmaceuticals (USA)

Preparation of SOPs for large scale production equipment and Process Automation system

1998

Compression/Encapsulation Department – Statistical Process Control project

1997

Novex Pharma Richmond Hill, Ontario

Validation projects for various systems and equipment, including:

• VHP Generator • HVAC system

Non-sterile Filling Line – Commissioning and IQ/OQ/PQ for monoblock filler, capper, crimper, labeler, checkweigher, cartoner and

2003

Client Project Year

vision system.

Blow/Fill/Seal Line, including compounding tanks and process piping system.

Novocol Inc. Cambridge, Ontario

Preparation and execution of IQ/OQ/PQ protocols for the purified water, HVAC, compressed air and sterilizer.

2001

Novopharm Ltd. (TEVA) Toronto, Ontario (Partnership since 1998)

Preparation of the VPP for the expansion of 2 existing facilities.

Qualification of each facility – preparation and execution of protocols for various utility systems such as HVAC, Compressed Air, Purified Water System, and manufacturing and packaging equipment.

Preparation of the QMP for 6 facilities; Qualification of each facility – preparation and execution of protocols for the Facility, HVAC, Compressed Air, Pure Steam and BAS systems

Warehouse Facility Qualification, including the preparation of the Qualification Master Plan

2001-2003

1998-2000

Nuvo Research Varennes, Quebec

Qualification of various lab equipment and incubators, including evaluation and execution

2001

On-Ice Express Toronto, Ontario

Provided GMP guidance temperature controlled distribution services. Development of Validation Master Plan for GMP and related temperature controlled distribution services.

Additional compliance services also included: • cGMP review of internal distribution

and handling processes • cGMP review of local SOP’s

Protocol preparation and execution. Validation of 16’ temperature controlled transportation trailers including IQ/OQ/PQ with focus on: • Trailer on board monitoring systems, • Temperature control systems, • Empty chamber, loaded chamber

temperature mapping studies. • Temperature recovery studies

Parima Validation of water system, neutralization 2002

Client Project Year

St-Laurent, Quebec system, HVAC, compressed air and architectural finish

PendoPharm Montréal, Quebec

Personnel loan to Validation department

Validation of Kalix-Dupuy Filler, air mixers and tanks.

2004

PerfectLab Quebec, Quebec

Qualification (IQ, OQ) of various process equipment.

2006

Writing of Validation Master Plan and qualification of equipment utilities and process equipment for a solid dosage facility.

2002

Pfizer Canada Inc. Arnprior, Ontario

Qualification of the Filling System

Validation of the Vision System

1996

Pharma Lab Quebec, Quebec

Provided assistance to the validation department for evaluation of cleaning validation of equipment.

2006

Pharmascience Montréal, Quebec

Validation of a LIMS 2006

Training on lyophilisation techniques 2005 Personnel loan to Validation department.

Validation of the following equipment: • 200K Tray Drying Oven • Fast coat (tablet coating assembly) • Purified Water System • High Shear Mixer/Granulator • Roller Compactor • Tablet Counting Machine • 5kg and 15kg Fluid Bed Dryers • Bin Blender

2004

Validation of the new Production Facility including:

• HVAC systems (IQ,OQ,PQ) • Clean compressed air (IQ, OQ, PQ) • Neutralization system (IQ,OQ,PQ) • USP water (IQ,OQ,PQ, PQ sampling

Note: PQ was completed only 12 weeks after Site Acceptance by Client.

2002-2003

Client Project Year

Audit, conformity on Performance qualification protocols

Audit on process validation

2001

ProMetic Pharma Inc. Toronto, Ontario

Equipment and Utilities Qualification – Vial Tunnel, Vial Filler, Vial Washer, Capper, Autoclave; HVAC, WFI, and Pure Steam systems

1999

Ratiopharm Mirabel, Quebec

Qualification of a new HVAC (IQ,OQ) with BAS amendment (IQ, OQ, PQ) for new production area

Preparation of related SOPs

2004

Rougier Bio-tech Montréal, Quebec

Validation of the upgraded facilities; HVAC, BAS and Compressed Air

Qualification of a new clean room suite and production equipment, including the preparation of the Validation Master Plan and applicable SOPs

1997 1995

Roussell Institute Pre-Inspection Audit (PIA) in regards to an FDA inspection

Validation of process equipment

2005

Sabex Inc. Boucherville, Quebec

Validation including IQ/OQ/PQ, writing protocols, implementing validation and preparing final reports for:

• Vial washing machine • Sterilizing tunnel • Capping equipment

2003

Validation for systems and equipment for parenterals, ophthalmics, creams and solid dosage facility, including:

• Processing equipment • Filling equipment • Washers • Cappers • Clean Utilities, Medical Gas, WFI • CIP System

2002

Support to the validation department for the following equipment:

• Incubators

2001

Client Project Year

• Cold room • Packaging Lines • Sterilizers • Washing machines

Support to the validation department for the FDA pre-approval inspection

Document preparation and reviewing (protocols, Validation Master Plan, validation files, etc.)

Dry Heat Oven

Validation of the depyrogenation process for a new vial load in a dry heat oven

Preparation of qualification protocols and final report, along with support to the validation team

2000

Schering Plough (Canada) Kirkland, Quebec

Validation of the SCADA system 1995

Process Validation 1999

Shire Canada Oakville, Ontario

Documentation Review and Validation of the Modifications to the Building Monitoring System

2000

Skelton Truck Lines Sharon, Ontario

Provided GMP guidance temperature controlled distribution services.

Protocol preparation and execution. Validation of approximately (28) twenty-eight 30’ - 53’ temperature controlled transportation trailers including IQ/OQ/PQ with focus on: • Trailer on board monitoring systems, • Temperature control systems, • Empty chamber, loaded chamber

temperature mapping studies. • Temperature recovery studies

2002 -2004

Steris Beauport, Quebec

Validation of the HVAC and BAS for the BioSafety Level 2 (BSL2) laboratories.

2004

Topigen Montréal, Quebec

Audit regarding GLP (21CFR part 58) for a clinical research organisation

2004

Tyco Montréal, Quebec

Audit of the Preventive Maintenance Department and recommendation for improvement

Ongoing

Client Project Year

GMP training

Valeant St-Laurent, Quebec

QA/QC and production support

Update, improve and write SOP’s of the QA/QC Systems: • Complaints • Management of SOP’s • Management of Training • Change Control • Internal Audits and External Audits • Vendor Audits and Qualifications • Corrective Action and Preventive Action

(CAPA) • Event Investigation • Re-Work and Re-Process • QC Sampling (Raw, Manufacturing,

Packaging and Laboratory Material)

2006

QA/QC and production support

Implementation of a CAPA system

2005

Vetoquinol Prolab Inc., Princeville, Quebec

Cross Contamination Study – Preparation of a report with comments and recommendations regarding regulatory conformance with Canada, US and EU

2005

Wyeth Montréal, Québec

Commissioning of utilities (plant and clean utilities plumbing, electrical and mechanical) and HVAC for the renovation of laboratories in Buildings 14 and 11.

Ongoing

5. PERTINENT EXPERIENCE - AUTOMATION AND INTEGRATION

The Automation and Integration group has renowned expertise in the pharmaceutical industry. The group has successfully completed, on time and on schedule, many projects, ranging from simple control systems to the most complex integrated automated production systems. Moreover, within the scope of the development of a control system for the production of liquid products for the American market, the group was successfully audited by the international pharmaceutical group, Novartis.

The Integration department has all the technical personnel required to complete all manufacturing and packaging projects. The term Integrated System applies to our team, meaning that no sub-contractors are required, consequently improving efficiency, and team communication, reducing installation costs, and ensuring client satisfaction, thereby allowing us to ensure total dedication and satisfaction to all our customers.

You will find hereafter a partial listing of the our group’s pertinent projects:

I.C.C.E. SA / NV, Brussels, Belgium

• Development of IT solution prototypes to meet GMPs.

YSI Inc., Yellow Spring, OH

• Software development.

Lilly del Caraïbe, Carolina, Puerto Rico

• Delta V software / New Bulk Humalog.

Eli Lilly & Co., Indianapolis, IN

• Preliminary engineering for the development of an Autoturb System.

• Design and development of Microbiological Autoturb Assay System software.

• Autoturb proof of concept study to identify the best software design for the Autoturb Project.

Eli Lilly & Co., Indianapolis, IN

• Preliminary engineering for the Biuret Reporting System.

• Design and development of Biuret system software.

Sabex 2002 Inc., Boucherville, QC

• Vacuum system for adding ingredients in powder form: controls and instrumentation.

AETERNA Laboratories, Quebec City, QC

• Computer systems assessment with respect to 21 CFR part 11.

E-Z-EM Canada, Montréal, QC

• Production relocation pre-feasibility study (2003).

• Feasibility study on Paclitaxel production. Preparation and issuance of PFDs and final report (2002).

Novopharm, Stouffville, ON (2003)

• Design of a USP 24 purified water system.

Centre Hospitalier universitaire de Québec (Université de Québec Hospital Center), Hôtel Dieu de Québec, Montréal, Quebec (2003)

• Kidney dialysis: purified water system upgrade.

Merck Frosst Canada & Co., Montréal, QC

• MK-734 Project.

Draxis Pharma, Montréal, QC

• Topical Room: control system upgrade.

• Topical Room: control system (2000).

Schering Canada Inc., Pointe-Claire, QC

• Preliminary analysis for an electronic weighing system.

• Control system support service.

• Environmental control system (2000) upgrade.

• Control system for purified water system (2000).

• Development and installation of a control system for Room 111 (2000).

• Development and implementation of a new data and temperature system (2000).

Therapex – Division of E-Z-EM Canada Inc., Anjou, QC

• Lee Room: installation of a process control system (1999).

Biomatrix Médical Canada Inc., Pointe-Claire, QC (1999)

• Data acquisition and process control system: analyses and recommendations.

ConjuChem Inc., Montréal, QC (1998)

• New research laboratories: development of a report defining scope of work.

Novartis Pharma Canada Inc., Dorval, QC Development and implementation of a control system for receiving, storing, and distributing bulk sugar in liquid form

This project consisted in setting up an independent control system to manage and move liquid sugar used in bulk for the various production processes in the plant.

Automation and/or integration services rendered

Operator interface programming (Factory Link) and PLC programming (TI 555) controlling outside reception panels as well as storage tanks and distribution lines inside of the plant. Specifications, development, and commissioning of the system and cleaning of equipment in contact with the liquid sugar by circulation.

DSM Biologics (previously Bio-Intermediair Inc.), Ville Mont-Royal, QC Design, construction and start-up of a plant, utilities and biotechnological production processes The company and its facilities provide cGMP contract manufacturing services to biotech and pharmaceutical companies in the US, Europe, and the Far East. The focus is on products derived from mammalian and prokaryote fermentation and purification. The facility contains areas that are approved for work with biological materials requiring a BL2LS containment level. In fact, the clean room area provides a dedicated fermentation suite for each product and up to eight products may be manufactured in parallel depending on their respective levels of containment and application. The total surface area of the plant is 45,000 square feet.

Automation and/or integration services rendered

Planning, design, documentation, programming, installation and validation of the architecture and of the independent control systems in the production rooms (Softscreen) and on utilities as well as for a central system for the management and monitoring of production activities (FIX DMACS).

Novartis Pharma Canada Inc., Whitby, ON Development and implementation of a control system for the production of a liquid destined for the American market

The goal of this project was to start up an area for the automated production of liquids in a remarkably short timeframe (fast-track method). All production and cleaning steps are automated.

Automation and/or integration services rendered

Preparation of control system specifications documents (URS, FRS, DDS, P&ID, control loop diagrams, and so on), development of the PLC code (TI 545) as well as that for the operator interface (Citect).

Pfizer Canada Inc., Arnprior, ON Visine Line

This project, which was carried out in two phases, consisted in the supply and installation of equipment for the production and packaging of Visine for the international market.

Automation and/or integration services rendered

P&IDs, instrument list, instrument specifications, control network architecture, control panel design, instrument location drawings and connection diagrams, supervision of installation and automation work, PLC programming and operator interface configuration and programming, commissioning, preparation of operation and maintenance manuals, operator training, assistance in IQ and OQ activities.

Pfizer, Arnprior, ON Ophthalmic Liquid Line – 300 bottles per minute

This project consisted in the creation of drawings and specifications to integrate new equipment and modify automation to maximize the packaging line speed from 70 vials to 180–250 vials/minute. The project included tender assessment and recommendations to the client. Partial work supervision, start-up assistance, and validation service assistance were also provided.

Martec Pharmaceutical, Kansas City, MO Hormone granulation

• Glatt SWG 120 Fluid Bed Granulation Dryer

This project consisted in the installation of one used Glatt SWG 120 fluid bed granulation dryer.

Automation and/or integration services rendered

The complexity of this project resided in the fact that the equipment was missing components, which had been left at the previous owner’s premises.

Piping, plumbing, structural, and roof work were coordinated by our on-site technicians.

The validation work was provided by SNC-Lavalin Pharma’s Validation group.

• Eurovent Fluid Bed Granulation Dryer

This project consisted in the installation of a Eurovent fluid bed granulation dryer.

Automation and/or integration services rendered

All phases of installation for this project were supervised and accomplished by our technicians, including roof work and steam piping.

Mallinckrodt, Hobart, NY Lab equipment for special projects

This project consisted in the installation of a Eurovent 25-liter fluid bed granulation dryer and a 25-liter high-shear mixer.

Automation and/or integration services rendered

Both units were second hand. The installation also included the supply of a dehumidification unit.

6. PERTINENT EXPERIENCE – PROCESS ENGINEERING

Laboratoires Riva

Preparation and issuing of a report detailing recommendations to improve the existing purified water system.

Design and preparation of PI&Ds, drawings and specifications for the installation of a new USP purified water system; construction and project management.

Shire Biochem

Studies aimed at increasing influenza vaccine production capacity, including development of PFDs and PI&Ds of the manufacturing processes.

Church & Dwight Canada

Preliminary phase study of a new USP purified water system, Phase 2. Report preparation and issuance.

Infectio Diagnostic Inc.

Preparation of PFDs, feasability studies and recommendations with regard to solutions for maximizing operations; preparation of a call for tenders document and further bids sollicitation for the purchase of a labeller (ongoing).

Université de Montréal – Main building and containment units

Productions animales et qualité de l’environnement (PAQE) (Animal production and environmental quality) – Preliminary study (ongoing).

Dermolab Ltd.

Assessment of the purified water system’s operating condition. Issuance of a network drawing and recommendations report.

Ethypharm Inc.

Design of the sterile suite for 5FU production. Detailed engineering for plant expansion; P&ID preparation; call for tenders document preparation to purchase equipment (autoclave, lyophiliser, pure steam generator, biosafety cabinets, and other small equipment).

Pharming, SGF

Development of a transgenic cow milk protein recovery process.

Novopharm

Design of a USP 24 purified water system.

Aventis Pharma Inc.

Preliminary study of the purified water system.

Eli Lilly

Optimisation Study of the water-for-injection (WFI) network.

Preliminary and detailed engineering of a new USP purified water system including preparation of PFDs, P&IDs, and functional specifications.

Transition package for the new storage and distribution of purified water.

Bioniche Life Sciences Pharma

Corrective measures established and call for tenders documents prepared for work on the pretreatment, and water-for-injection (WFI) production systems and networks.

Sabex 2002 Inc.

Studies and recommendations aimed at retrofitting production areas. Development of PFDs and layout plans of the new production lines (2003).

Design and detailed engineering of a vacuum intake system (2003).

Haemacure Corporation

Feasability study for the construction of a new production and packaging plant for a biological adhesive made from a human blood-derived protein. This study included PFD development, mass balance, and overall process analysis.

E-Z-EM Canada

Feasibility study on Paclitaxel production. Preparation and issuance of PFDs and a final report.

Université de Montréal Hospital Research Centre

Functional and Technical Program for the Public Health Research Centres, the Immunology, Virology and Vaccines Institute of Montréal, Biomaterials Research Centre, and Orthopedic Imaging Research Centre. Report issuance (2002).

Development of process flow diagrams (PFDs) for cancer treatment (1999).

Advitech Solutions Inc.

Production of maximization studies and PFD development.

Pharmascience

Analysis of processes and preliminary studies of future R&D and production facilities. Report preparation and issuance (2000).

Production study and project cost estimate.

MDS Nordion

Study of radioactive waste treatment from a sterilizer (2003).

Design of a washing pan device for a glassware washer (2003).

Detailed engineering of the new water room and component preparation rooms: overall revision of clean utilities design including water-for-injection production network; preparation of drawings and specifications for call for tenders; partial work supervision.

Proxima Project: studies and recommendations for possible solutions to maximize handling and manufacturing of the IOTREX™ radioactive product. PFD and report preparation and issuance.

Merck Frosst

Improvements to the USP water production system in Building No. 9. Drawings and specifications for call for tenders (2004).

MK-734 Project for Merck Frosst Canada & Co.: preliminary studies, final drawings, and specifications for a new tablet production project and process waste water treatment (2002).

Conveyor network study for incoming and outgoing warehouse products (1997).

Héma-Québec

Definition and preparation of process flow diagrams (PFDs) for blood handling processes.

Astra Pharma Inc.

Warehouse and manufacturing plant expansion for the addition of Blow-Fill-Seal (BFS) fillers: feasibility study of resin transfer systems; process flow diagram (PFD) development; and preparation of final drawings and specifications for call for tenders.

Bioniche Life Sciences Pharma

PFD development for the production of vaccines destined for human and animal use. Flow diagram development for four (4) new filling, labelling and packaging lines for 1000- and 2000-mL vials.

Schering Canada

Preparation of drawings and specifications for the installation of a USP XXIII purified water production system. Call for tenders and partial work supervision.

Pepco Plant for Theratechnologies

Pepco Plant, preliminary study for solvent transfer, distribution and waste disposal (2000).

Therapy pilot plant – PFD preparation (1999).

Corporation Pharmaceutique Professionnelle

Plant retrofit. Preparation of drawings and recommendation report (2000).

Purified water system. Preparation of drawings and specifications for call for tenders (1999).

Biomatrix Médical Canada Inc.

Report on modifications to the deionized water system (2000).

Utlities P&ID development (2000).

Explosion-proof room for two (2) new 4000-L tanks. Preparation of drawings and specifications for a call for tenders (1999).

Purified water system analyses. Report issuance (1998).

Explosion-proof room – Room 16. Preparation of drawings and specifications for a calls for tenders (1998).

DSM Biologics

Design of Centocor processes (2003).

“Large Scale Expansion Project”, P&ID and functional specifications development for downstream process equipment (including chromatograph and filtration system) (2002).

Modifications to the purified water system. Report issuance (1999).

Galderma Production, Cream and lotion manufacturing plant

Pre-project and preparation of specifications for the purchase of manufacturing skids; preliminary development of CIP processes; call for tenders specifications for supply and installation of six (6) filling and packaging lines for containers, tubes, and bottles, a CIP system, an automatic washer for detachable parts, and various manufacturing equipment and palletizers (1998); site supervision; start-up assistance.

Vaccine production centre for IAF Biovac

Preliminary study for the installation of centrifuges in accordance with Good Manufacturing Practices.

Schering

Operating assessment of purified water, pure steam, and water for injection systems. Report issuance.

Huntsman Chemicals

Polystyrene bead manufacturing area expansion. Pre-project study for the addition of a third reactor.

Bio-Intermediair of North America: New research and biopharmaceutical production centre

Design of process and CIP/SIP systems and networks for the production of antibodies via fermentation and purification processes of products resulting from bacterial fermentation.

Development of piping, process and CIP diagrams; development of waste and decontamination diagrams; preparation of equipment layout and piping plans, isometrics and specifications for call for tenders; tenders assessment and recommendations to Bio-Intermediair; work supervision and start-up assistance.

Pfizer Canada Inc., Arnprior Plant

Secondary 8000-litre Visine tank ($500 000, 1998):

Process and CIP piping design to connect this new tank to the production system installed in 1997. Development of piping, process, and CIP diagrams, and equipment and piping layout plans; preparation of drawings and specifications for call for tenders; bid assessment and recommendations for Pfizer; partial work supervision and start-up assistance.

Design of piping, process, and CIP networks for the production of Visine. Development of piping and process diagrams for the CIP processes; development of layout plans for an 8000-L preparation tank and other equipment; piping,

preparation of drawings and specifications for purchase tenders; sollicitation and assessment of tenders; recommendations for Pfizer; partial work superivision and start-up assistance (1996).

Visine Packaging Line (1996):

Maximization and new layout for the Visine packaging line. Line speed was increased from 70 vials (10 and 15 mL)/minute to 180 to 250 vials/minute. Technical surveys of the plant; developing PFDs and new layout drawings; preparing specifications for performance and integration work; call for and assessment of tenders; recommendations for Pfizer; partial work supervision and start-up assistance.