IPI - Outsourcing & Innovation Supplement - 2014

Outsourcing & InnovationSupplement 2014

www.ipimedia.comInternational Pharmaceutical Industry Supporting the industry through communication

Biologics & small molecule fill & finish

Clinical & commercial supply to 45+ local markets

On-site development and bio-analytical expertise

Advanced lyophilization capabilities

Flexible labeling and packaging

Cold chain management

QP Release services

McPherson, USA

Zagreb, CroatiaLiscate, Italy

NORTHAMERICA EUROPE

Let’s talk

KNOWLEDGE | EXPERIENCE | EXPERTISE

Call +1-224-212-2267 or +44 (0) 1926 835 554 or e-mail [email protected]

GLOBAL REACH | SECURITY OF SUPPLY | EFFICIENCY

THE POWER OF

COMPLEMENTARY CAPABILITIES

Hospira, Inc., 275 North Field Drive, Lake Forest, IL 60045P14-0381-9-210x297mm-Aug., 14

PLEASE VISIT US AT ICSE/CPhI 2014, Paris | BIO-Europe 2014, Frankfurt

INTERNATIONAL PHARMACEUTICAL INDUSTRY 1www.ipimedia.com

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2014 PHARMA PUBLICATIONS

IPI - OUTSOURCING & INNOVATION

SUPPLEMENT 2014

International Pharmaceutical Industry Supporting the industry through communication

BIOLOGICS

02 – 03 Cobra BIOLOGICS

04 – 05 GLYCOTOPE

06 – 07 FEF CHEMICALS A/S

08 – 09 VALSYNTHESE

CDMO/CMO

10 - 11 HOSPIRA ONE 2 ONE

12 - 13 GROUPE SYNERLAB

14 - 15 VETTER PHARMA INTERNATIONAL GmbH

Outsourcing & Innovation

Supplement 2014

PACKAGING

16 - 17 PACKAGING COORDINATORS

18 - 19 SCHOTT AG

LOGISTICS & SUPPLY CHAIN

20 - 21 BERLINGER & Co. AG

22 - 23 TESTO LIMITED

24 - 25 TURKISH CARGO

PRODUCTS & EQUIPMENTS

26 - 27 DRIAM GmbH

28 - 29 Federal Equipment

30 - 31 Woodley Equipment Company Ltd

2 INTERNATIONAL PHARMACEUTICAL INDUSTRY IPI Outsourcing & Innovation Supplement 2014

Biologics

ExpertiseCobra Biologics is a rapidly expanding international contract manufacturing organization (CMO) of biologics and pharmaceuticals for clinical and commercial supply. Cobra has three GMP approved facilities in the UK and Sweden, each with expertise tailored to serving our customers across the world. We offer a broad range of integrated and stand-alone contract services; stretching from cell line and process development through to fill and finish for the supply of investigational medicinal products and commercial production.

ExperienceFor over 16 years we have taken pride in being a trusted manufacturing provider, delivering what we promise and helping our customers to develop medicines for the benefit of patients. Cobra provides manufacturing technologies, platforms and solutions to the pharmaceutical industry covering antibodies, recombinant proteins, viruses, phage, DNA as gene therapies, whole cell vaccines and therapeutics as well as biologics and small molecule API lyophilisation and fill finish.

ExcellenceAt Cobra, we recognize the value of transparent and effective communications with our customers. We ensure that we provide regular progress updates as well as respond to our customers’ needs. Large enough to deliver and small enough to care, Cobra dedicates the attention and resources needed with multidisciplinary teams that remain with each program throughout its life. This seamless integration reduces both transfer risk and time delays, thereby increasing customer satisfaction. Delivering the highest quality products on schedule through trusted relationships ensures that our customers come back for further clinical development and production or with new projects.

Find out more, take a virtual tour and get in touch with our expert team today at www.cobrabio.com

Case study: Minimizing drug product losses in small volume aseptic fillingCobra’s facility in Matfors, Sweden, specializes in aseptic filling using modern, fully automated and disposable systems. Our track record of successful drug product deliveries range in batch size from 3.5L to 50L or more. Historically, the filled products have been manufactured from low cost, small molecule APIs where up to 1L of product waste has been acceptable, for example from line losses and integrity testing of filters, however to better accommodate high value APIs in small volume fills, biologics such as plasmid DNA, recombinant proteins, and antibodies (MAbs) required a solution.

A project was initiated to minimize product losses. This was achieved by careful mapping of the fill process followed by small changes in the working procedure and the choice of disposables. This resulted in a more than 10-fold decrease in product waste.

Challenges & Constraints:• Reduce system volume losses• Minimize design changes • Minimize re-validation works• Minimize staff re-qualification • System design

Process Steps for Improvement:1. Key target points during filtration: • Saturation of filter• Remaining substance in compounding bag• Loss during filtration

2. Key target points during filling: • Losses due to filling weight adjustment• Losses during set up of the filling tubes• Loss of fluid due to failing check weights at end of filling• Loss of fluid trapped in the tubes and bag

Approach:Optimising filtration and fill process diagram:

Method:Filtration of ≈1.0 to 1.5L of H2O or buffer into ≈400 size 10mL vials with a fill volume of 3mL per vial.Results:Losses during filtration & filling process:

Conclusion and Outlook:Having optimized the filtration process with a reduction in downstream losses to less than 100mL, Cobra’s on-going project will be to further minimize volume losses, enhancing customer product yields, by thorough review of drug product sampling and validation procedures.

Cobra Biologics: Contract Manufacturing Excellence

Cobra invites you to visit our modern, purpose built, aseptic manufacturing facility in Matfors, Sweden.

Please visit our website to arrange a tour: www.cobrabio.com

Contract Manufacturing Excellence

Meet us at CPhI 2014 7-9 October Stand 1L20


Biologics

Glycotope was founded in February 2001 by Dr. Steffen Goletz and employs today more than 150 people at two sites in Berlin and Heidelberg. The company is based on two main technology platforms and a clinical pipeline of 4 mid to late stage projects. The main technologies are the GlycoBodyTM Technology creating new glycoepitope targeting antibodies for treatment of cancer and GlycoExpressTM for glycooptimising a broad variety of biopharmatheuticals resulting in BioSuperiors of e.g. already marketed compounds. GLYCOTOPE and its manufacturing arm GLYCOTOPE BIOTECHNOLOGY showed competence to develop compounds from very early to late stage, contributing significant improvements to healthcare and creating company value. Based on Glycotope’s portfolio and business concepts, the participation of Hexal founders Thomas & Andreas Struengmann in 2007 constituted one of the largest biotech investments in Germany.

Management: Dr. Steffen Goletz, CEO&CSODr. Franzpeter Bracht, CFO&COO

Technologies • Services• GlycoExpress, World’s broadest, most potent & validated

GlycoOptimization technology for improvement of the vast majority of antibodies & protein biopharmaceuticals

• GlycoBodies, Therapeutic antibodies against Glyco-Epitopes• GlycoProcess, Fermentation & purification for optimized

glycoprotein production• Design and conduct of immunomonitoring assays to support

clinical development• Immundiagnostics

Products• FSH-GEX™ (glycol-optimized follicel stimulating hormone) –

End of Phase II• PankoMab-GEX™ (anti-tumor MUC1 antibody) – Phase IIb• CetuGEX™ (glycol-optimized EGF receptor antibody) –

Phase IIb• TrasGEX™ (glycol-optimized HER 2 antibody) – End of Phase I

Contact Person: Franzpeter Bracht, Ph.D. Address / PO Box: Robert-Roessle-Str. 10Postal Code / City: 13125State: BerlinCountry: GermanyTelephone: +49 30 9489 2600Fax: +49 30 9489 2609E-mail Address: [email protected]: www.glycotope.com

Turning Glycomics into Health

CDMO/CMO

• Design and conduct of immunomonitoring assays tosupportclinicaldevelopment

• Immundiagnostics

Products• FSH-GEX™(glycol-optimisedfollicle-stimulatinghormone)

–endofPhaseII• PankoMab-GEX™ (anti-tumourMUC1 antibody) – Phase

IIb• CetuGEX™ (glycol-optimised EGF receptor antibody) –

PhaseIIb• TrasGEX™ (glycol-optimised HER 2 antibody) – end of

PhaseI

Contact Person: FranzpeterBracht,Ph.D.Address / PO Box: Robert-Roessle-Str.10Postal Code / City: 13125State:BerlinCountry:GermanyTelephone:+493094892600Fax:+493094892609E-mail Address: [email protected]: www.glycotope.com

GlycotopewasfoundedinFebruary2001byDrSteffenGoletz,and today employs more than 150 people at two sites inBerlin and Heidelberg. The company is based on twomaintechnologyplatforms,andaclinicalpipelineoffourmid-tolate-stage projects. Themain technologies are theGlycoBodyTMTechnology, creating new glycoepitope targeting antibodiesfor treatment of cancer, and GlycoExpressTM, for glyco-optimising a broad variety of biopharmaceuticals resulting inbiosuperiorsofe.g.alreadymarketedcompounds.Glycotopeand itsmanufacturing armGlycotope Biotechnology showedcompetenceindevelopingcompoundsfromveryearly-tolate-stage,contributingsignificantimprovementstohealthcareandcreating company value. Based onGlycotope’s portfolio andbusinessconcepts,theparticipationofHexalfoundersThomasand Andreas Struengmann in 2007 constituted one of thelargestbiotechinvestmentsinGermany.

Management: DrSteffenGoletz,CEO&CSODrFranzpeterBracht,CFO&COO

Technologies • Services• GlycoExpress; the world’s broadest, most potent and

validatedglycol-optimisationtechnologyforimprovementof the vast majority of antibodies and proteinbiopharmaceuticals

• GlycoBodies;therapeuticantibodiesagainstglyco-epitopes• GlycoProcess;fermentationandpurificationforoptimised

glycoproteinproduction

GLYCOTOPE – “Turning Glycomics into Health”

BRIEF HISTORY

COMPANY AT A GLANCE

SERVICES OFFERED

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API & Fine Chemicals

FeF Chemicals is the world-leading supplier of high-quality quaternary ammonium compounds, with a delivery and stock policy for pharmaceutical products that meets the most demanding and urgent requirements of its customers.

FeF Chemicals specialises in the pharmaceutical and personal care industries, providing quaternary ammonium compounds (quats) that comply with global regulations. The company provides only the very best and safest ingredients for formulation, preserving its quality and contributing to patient safety, and is the world-leading supplier of high-class quats.

For its cGMP-manufactured quats, the company offers: • global regulatory compliance • manufacture in accordance with the highest GMP standards

on the market, the ICH Guide Q7 for Active Pharmaceutical Ingredients

• high-purity products • analysis according to multi-compendial pharmacopoeias BP,

PhEur, USP/NF and JP • regulatory documentation.

FeF Chemicals’ quality system meets DS/EN ISO 9001 as well as the aforementioned ICH Guide Q7 for Active Pharmaceutical Ingredients. In-process samples, as well as finished products, are carefully analysed in a modern, well-equipped laboratory.

Fast and reliable services in documentation, analysis and

manufacturing, fulfilling local to international regulatory requirements, are the key to securing customer satisfaction.

The company’s delivery and stock policy for pharmaceutical

products is determined to meet the most demanding and urgent requirements of its customers, and pharmaceutical products can be shipped within a week. A range of products is also offered in a variety of packing solutions, meeting demands for small and large packaging.

Services Offered

The Best in Quats FeF Chemicals’ own innovative synthesis process ensures a very high level of purity of liquid and crystalline products such as benzalkonium chloride, strong cetrimide solution, cetrimide, cetrimonium bromide (CTAB) and myristalkonium chloride (MKC).

By using raw materials of high purity and following the company’s stringent quality system, products are particularly suited for applications within the pharmaceutical industry. They act

as preservatives in many ophthalmic, nasal and oral drugs, and as active ingredients in a variety of topical and antiseptic s o l u t i o n s , ointments and creams. For the cosmetic industry, the products’ purity and characteristics provide ideal conditioning, emulsifying and preserving effects in hair and cream products.

Thanks to a closely controlled production process, reducing

batch variation to a minimum, FeF Chemicals is highly valued by the diagnostic reagent sector. Combined with the high purity, the company’s quats have proven to be significantly superior to other less pure compounds.

If the required product is not in the standard assortment, FeF Chemicals can design customised products. Its flexible production process can meet customer demands for special chain-length distribution and/or solutions of quats mixed in various ratios.

The company is fully aware of the importance of the

registration phase for a drug within the pharmaceutical industry. As a consequence, it offers an extensive range of documentation on its pharmaceutical-grade products, such as multicompendial analysis and access to regulatory documentation.

FeF Chemicals ensures the best possible service and fast preparation of documentation, such as Drug Master Files for its pharmaceutical-grade products. In order to further facilitate the drug registration process for customers, the company offers access to its Certificates of Suitability according to the Monographs of the European Pharmacopoeia, for benzalkonium chloride solution 50%, benzalkonium chloride (95%) and cetrimide.

Company at a Glance

Company Values The company was first established in 1949. It was acquired by Novo Nordisk, a Danish healthcare company and world leader in diabetes care, in 1986, and has been part of the pharmaceutical group since then.

As a Novo Nordisk company, FeF Chemicals believes in respect for all employees and in creating a healthy working environment. Most important of all, it never compromises on quality and business ethics, and this applies to everyone who works for the company.

cGMP Manufacture Quarternary Ammonium Compounds for Pharmaceutical Use

• Global regulatory compliance

• Manufacture in accordance with the highest GMP standards on the market, the ICH Guide Q7 for Active Pharmaceutical Ingredients

• High purity products

• Analyses according to multicompendial pharmacopoeias BP, Ph.Eur., USP/NF and JP

• Security of Supply

• High level of service and support

Contact us for more information.www.fefchemicals.com a Novo Nordisk company

cGMP manufactured quaternary ammonium compounds for pharmaceutical use

are particularly suited for applications within the pharmaceutical industry. They act as preservatives in many opthalmic, nasal and oral drugs, and as active ingredients in a variety of topical and antiseptic solutions, ointments and creams. For the cosmetic industry, the products’ purity and characteristics provide ideal conditioning, emulsifying and preserving effects in hair and cream products. Thanks to a closely controlled production process, reducing batch variation to a minimum, FeF Chemicals is highly valued by the diagnostic reagent sector. Combined with the high purity, the company’s quats have proven to be significantly superior to other less pure compounds. If the required product is not in the standard assortment, FeF Chemicals can design customised products. Its flexible production process can meet customer demands for special chain-length distribution and/or solutions of quats mixed in various ratios. The company is fully aware of the importance of the registration phase for a drug within the pharmaceutical industry. As a consequence, it offers an extensive range of documentation on its pharmaceutical-grade products, such as multicompendial analysis and access to regulatory documentation.FeF Chemicals ensures the best possible service and fast preparation of documentation, such as Drug Master Files for its pharmaceutical-grade products. In order to further facilitate the drug registration process for customers, the company offers access to its Certificates of Suitability according to the Monographs of the European Pharmacopoeia, for benzalkonium chloride solution 50%, benzalkonium chloride (95%) and cetrimide.

Company values The company was first established in 1949. It was acquired by Novo Nordisk, a Danish healthcare company and world leader in diabetes care, in 1986 and has been part of the pharmaceutical group since then. As a Novo Nordisk company, FeF Chemicals believes in respect for all employees and in creating a healthy working environment. Most important of all, it never compromises on quality and business ethics, and this applies to everyone who works for the company.

cenrtimide,centrimoniumbromide (CTAB) and myristalkoniumchloride (MKC). By using rawmaterials of highpurity and following the company’s stringent qualitysystem, products

FeF Chemicals is the worldwide leading supplier of high-quality quaternary ammonium compounds, with a delivery and stock policy for pharmaceutical products that meets the most demanding and urgent requirements of its customers. FeF Chemicals specialises in the pharmacuetical and personal care industries, providing quaternary ammonium compounds (quats) that comply with global regulations. The company provides only the very best and safest ingredients for formulation, preserving its quality and contributing to patient safety, and is the worldwide leading supplier of high-class quats.For its cGMP-manufactured quats the company offers:

• global regulatory compliance • manufacture in accordance with the highest GMP

standards on the market, the ICH Guide Q7 for Active Pharmaceutical Ingredients

• high-purity products • analysis according to multi-compendial pharmacopoeias

BP, PhEur, USP/NF and JP • regulatory documentation.

FeF Chemicals’ quality system meets DS/EN ISO 9001 as well as the aforementioned ICH Guide Q7 for Active Pharmaceutical Ingredients. In-process samples, as well as finished products, are carefully analysed in a modern, well-equipped laboratory. Fast and reliable services in documentation, analysis and manufacturing, fulfilling local to international regulatory requirements, are the key to securing customer satisfaction. The company’s delivery and stock policy for pharmaceutical products is determined to meet the most demanding and urgent requirements of its customers, and pharmaceutical products can be shipped within a week. A range of products is also offered in a variety of packing solutions, meeting demands for small and large packaging.

The best in quats FeF Chemicals’ own innovative synthesis process ensures a very high level of purity of liquid and crystalline products such as benzalkonium chloride, strong cetrimide solution,

No Compromise on QualityBRIEF HISTORY

COMPANY AT A GLANCE

SERVICES OFFERED

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API & FINE CHEMICALS


API & Fine Chemicals

2. Brief HistoryValsynthese is a subsidiary of Société Suisse des Explosifs. Since its foundation in 1894, the group has acquired broad experience in the field of civil explosives, which has developed into expertise in hazardous and high-energy chemistry for the pharmaceutical and fine chemical industry. Today Valsynthese is a contract manufacturing organisation (CMO) offering solutions for your chemical needs where ever a high energetic material is involved. Currently capabilities are being extended by a Phosgenation plant.

• 1894 Foundation of civil explosives company Société Suisse des Explosifs (SSE)

• 1983 Foundation of Valsynthese as joint venture with French Pharma company

• 1995 SSE took full ownership of Valsynthese• 2013 Expansion into Phosgene and Azid Chemistry to widen

technological platform of high-energetic and hazardous reactions

3. Markets ServedValsynthese is mainly active in the Pharma business providing chemical intermediates and APIs. For Nitroglycerin bulk pharmaceutical intermediates are being produced e.g. for transdermal patches. Valsynthese is also active in other industries such as Agro, Fragrance & Flavours and Performance Materials. These are mostly chemical intermediates based on the technological platform Valsynthese is specialised in.

4. Services OfferedValsynthese offers custom synthesis and contract manufacturing of chemical intermediates and APIs. The company provides customers with complete solutions from process development to industrial production and from preclinical to commercial quantities. Services include process validation, stability testing and DMF preparation. A pilot plant and two multipurpose plants can produce under ISO or GMP standards. Valsynthese is providing the standard which fit to the customer’s needs.

High Energetic an Hazardous ReactionsValsynthese has extensive expertise and capabilities in the field of high-risk chemical reactions & energetic processes and where safe handling of hazardous reagents and substances is required. The required calorimetric measurements are performed in-house e.g. by RC1, DSC and others.

Chemical and Technological DevelopmentTogether with the customers and stack holders Valsynthese strives to adapt the technology in a manner that a reliable, cost effective and sustainable supply can be ensured. An open and transparent communication during the process development is a basic principle in Valsynthese project management. Needless to say that your know-how is protected to the highest standards. Your ideas are grown from laboratory scale to a full scale production. Skilled personnel and well equipped laboratories and a GMP pilot plant are available to your needs.

Phosgenation ChemistryPhosgene is a powerful reagent allowing in an effective way access to key reactives such as chloroformates, acid chlorides and carbamoyl chlorides, thereby permitting the clean and efficient construction of isocyanates, carbonates, carbamides or ureas. A dedicated laboratory for safe handling of phosgene during process development has been newly installed (see picture). The hazardous potential of using phosgene is well known. With this in mind, the Phosgenation plant has been constructed to the highest safety standards, guaranteeing safe and environmental friendly working conditions. By using phosgene Valsynthese is able to offer you both quality and value for money.

Quality you can trustValsynthese is certified according to ISO 9001 and is cGMP approved by SWISSMEDIC (Swiss Health Authority). Continuous improvements of our quality and manufacturing processes are a benefit for the customers to always comply with the latest regulations and to guarantee best prices. For all industries the related quality requirements are adapted to achieve customer’s satisfaction. Valsynthese regulatory and cGMP services include process validation, preparation of DMF and stability testing according to ICH guidelines. Various DMF have been submitted to European and Japanese Health Authorities.

GMP Facilities• 2 Multipurpose plants with reactors from 500 to 4000 litre• High pressure reactor up to 25 bar (2500 l)• Centrifuges, filter nutsche dryer, vacuum mixing dryer• Phosgenation plant with phosgene generator (40 kg/h)• Clean room plant for pharmaceutical intermediates

preparations• Continuous manufacturing plant for Nitroglycerin, Pharma

Grade

5. Company at a GlanceValsynthese is a reliable partner for your chemical needs in your next development project or when outsourcing intermediate steps or APIs. Starting from early requirements of first samples to the bulk quantities of kilograms and tons you have one partner to speak with. With Valsynthese your chemistry is in safe hands.

Innovative solutions for your Chemical Needs

1. Contact InfoValsynthese SASociété Suisse des Explosifs GroupFabrikstrasse 483900 BrigSwitzerland

Tel: +41 27 922 71 11Fax : +41 27 922 72 [email protected]

23/09/13 - IPI - Outsourcing Supplement (final).indd 13 08/10/2013 07:09


CDMO/CMO

Hospira’s One 2 One™ business is a world leader in the custom development and manufacture of parenteral products. Whether your product is a small molecule or advanced biologic, One 2 One™’s highly qualified personnel in every world-class facility ensure quality, capacity and security of supply.

Technical ServicesOne2One™ is able to manufacture injectable products in a broad range of delivery systems including:

• Vials, bottles and ampoules• Glass and Plastic Prefilled syringes• Cartridges for self-administration devices

One2One™ has the ability to manufacture a variety of injectable

products, and has a broad range of capabilities and experience with different types of molecules: • Biologics• Small molecules• Vaccines• Cytotoxics• Controlled Substances• Highly potent compounds• • Aseptic Fill/Finish• CTM / registration batches• Lyophilization• Sterile Powder Filling• Terminal Sterilization• Multilingual packaging and labeling• Cold chain management FacilitiesOne2One™ primarily works with four parenteral manufacturing facilities in North America, Europe and the Asia Pacific regions, each registered with multiple regulatory agencies worldwide:

• McPherson, Kansas, USA: A leader in biologics Fill/Finish• Liscate, Italy: Powder filling and lyophilization• Zagreb, Croatia: Biologics Fill/Finish• Mulgrave (Melbourne), Australia: Cytotoxic Fill/Finish

The Power of Complementary Capabilities

Biologics & small molecule fill & finish

Clinical & commercial supply to 45+ local markets

On-site development and bio-analytical expertise

Advanced lyophilization capabilities

Flexible labeling and packaging

Cold chain management

QP Release services

McPherson, USA

Zagreb, CroatiaLiscate, Italy

NORTHAMERICA EUROPE

Let’s talk

KNOWLEDGE | EXPERIENCE | EXPERTISE

Call +1-224-212-2267 or +44 (0) 1926 835 554 or e-mail [email protected]

GLOBAL REACH | SECURITY OF SUPPLY | EFFICIENCY

THE POWER OF

COMPLEMENTARY CAPABILITIES

Hospira, Inc., 275 North Field Drive, Lake Forest, IL 60045P14-0381-9-210x297mm-Aug., 14

PLEASE VISIT US AT ICSE/CPhI 2014, Paris | BIO-Europe 2014, Frankfurt


Chapter Title

CDMO/CMO

20



Zone Industrielly de Krafft • 67150 ERSTEIN • FRANCE • +33 3 88 98 19 27 www.synerlab.com


CDMO/CMO

Vetter is an international specialist in the production of aseptically prefilled syringe systems, cartridges and vials. We are a family-owned, independent company and do not manufacture our own drugs.

Our focus is on providing highly skilled support and state-of-the-art manufacturing resources - from the initial phases of clinical development and regulatory approval process through successful product launch, commercial manufacturing, and life cycle management.

Resources for every stage of growth.Vetter’s full portfolio of services includes dedicated resources for both clinical development and commercial manufacturing. In addition, we provide expert packaging technologies and solutions tailored to your product’s specific market needs.

Vetter Development ServicePlanning for successPreclinical through Phase III is a pivotal and unpredictable period for new molecules. Vetter Development Service helps smooth the path to clinic with dedicated support for key stages of development, testing, clinical manufacturing, and regulatory approval. We also help you integrate thoughtful, efficient life cycle solutions for long-term growth and success. Vetter Development Service provides:

• Formulation support• Process development• Clinical trial manufacturing• Analytical service• Regulatory support

Vetter Commercial ManufacturingFilling your potentialPrecise manufacturing. Creative thinking. It takes both to succeed in a competitive marketplace. Vetter Commercial Manufacturing supports your injectable with more than 35 years of expertise in high-quality, state-of-the-art aseptic filling - and experience-based solutions that add value and increase efficiency. Vetter Commercial Manufacturing provides:

• Fill and finish• Analytical service• Regulatory support• Product life cycle management

Vetter Packaging SolutionsPackaging mattersMaterial compatibility. Patient convenience. Market differentiation. There are many factors to consider in the selection of your primary and secondary packaging materials. Which ones matter most to your compound’s performance and long-term potential? Vetter’s packaging experts help you find the right solutions throughout your product’s life cycle.

Vetter Packaging Solutions provides: • Customized packaging development• Specialized technologies• Proven platform technologies• Packaging services• Logistic services

Fast facts: Vetter-at-a-glance• Headquarters in Ravensburg, Germany• Additional clinical development facility in Chicago, US• Approximately 3,300 employees• Worldwide specialist in the aseptic production of prefilled

drug delivery systems• Global experience and expertise with regulatory authorities

including FDA, EMA, PMDA (Japan), and RP (Germany), in multiple countries

• Numerous patents including technologies for protection against tampering and counterfeiting

• Lyophilization (freeze-drying) and siliconization specialist

ContactFor US inquiries please contact +1-847-581-6888 or [email protected].

For EU inquiries please contact +49-751-3700-0 or [email protected].

Visit www.vetter-pharma.com for more information.

A strategic partner focused on your success

For US inquiries please contact [email protected] or for EU, Asia and other international inquiries, please contact [email protected].

Answers that workwww.vetter-pharma.com

Complex packaging? Vetter is the simple choice. Today’s demand for injectables that meet both patient convenience and market requirements can make secondary packaging complex. But your choice of a packaging partner should be simple: Vetter.

Our packaging development experts support you from early packaging concepts through to market launch. The team is ready to help with:

n Flexibility to meet custom packaging and serialization needs

n Expertise in specialized packaging, including complex pen/autoinjector assembly and kit packaging

n Broad spectrum of packaging options, from blister packaging to toploader cartoning

For packaging solutions tailored to meet your product and patient needs, there’s a simple choice. Choose Vetter.

Learn more at CPhI / ICSE 2014 in Paris at Booth # 1G35.

Vetter_SecondaryPackaging_Ad_CPhI/ICSE_210x297.indd 1 19.09.14 15:49


Packaging

The global healthcare industry trusts PCI for the d e v e l o p m e n t solutions that increase products’ speed to market and opportunities for commercial success. Only PCI brings the proven

experience that comes with more than 50 successful product launches a year and over four decades in the healthcare business. Leading technology and continued investment enables us to address development needs throughout the product life cycle – from Phase I clinical trials through commercialization and ongoing supply. Our clients view us as an extension of their business and a collaborative partner, with the shared goal of improving patients’ lives.

FacilitiesFacilities in North America and Europe support products destined to over 100 countries. Our state-of-the art cGMP facilities feature site segregation for Schedule II-IV Controlled Substances, Cold Chain, Animal Health, Hormonal Products, Penicillin Products, Cytotoxins, and Band 1-4 Potent Compounds. Facilities support Cold Chain packaging and distribution at 2-8°C, -20°C, and -80°C, low humidity packaging, as well as modified environments for oxygen and light sensitive products.

Products And ServicesPharmaceutical Development and Contained Product Manufacturing: through the services of Penn Pharma

Clinical Trial Services: Global Storage & Distribution and Returns Management & Destruction

Packaging Services: Primary Packaging, Secondary Packaging, Parenterals and Injectables, Device Assembly, Compliance Prompting & Child Resistant Packaging, Overlabeling & Expiry Date Extension

Support Services: Project Management, Protocol Interpretation, Comparator Product Procurement, Product Blinding, Label & Randomization Generation, Translation Services, QP Services, Distribution & Logistics Planning, Package Design & Development, IVRS/IWRS & Web Connectivity

Laboratory Services: Analytical Development & Testing, Stability Testing, Microbiological Testing and Import testing for EU requirements

Recent DevelopmentsMay 2013 - PCI acquires the services of AndersonBrecon, Inc. from AmerisourceBergen Corp.

August 2014 - PCI finalizes the acquisition of Penn Pharma

September 2014 - PCI completes construction of new 93,000 sf Clinical Storage & Distribution facility inRockford, IL

OUR TEAMCEO and PresidentBill Mitchell

Chief Operating OfficerBill Bolding

Sr. VP Sales & MarketingPhil DiGiacomo

Sr. VP Global Clinical ServicesRobert Misher

Exec. Dir. - Marketing, Bus Dev & DesignJustin Schroeder

Dir. Business Development (E.U.)Craig Taylor

Chief Executive Officer - Penn PharmaRichard Yardwood

Director of Business Development - Penn PharmaRob Jones

LOCATIONSCorporate Headquarters3001 Red Lion Rd.Philadelphia, PA 19114+1 215 613 3600

Rockford, IL4545 Assembly DriveRockford, IL 61109+1 815 484 8900

Woodstock, IL2200 Lake Shore DriveWoodstock, IL 60098+1 815 206 1500

EuropeUnited KingdomWye Valley Business ParkHay-on-Wye, HR3 5PG+44 (0) 1497 820829

PENN PHARMAUnited Kingdom23-24 Tafarnaubach Industrial EstateTredegar, Gwent, NP22 3AA

Global Reach with 15 Packaging Facilities in North America and Europe

© Copyright 2014 Packaging Coordinators, Inc. All Rights Reserved.

Global Reach with 15 packaging facilities in North America and Europe

Clinical Trial Services

Manufacturing Services

Commercial Services

Laboratory Services

www.pciservices.com

One Expert TeamTwo Industry Leaders Have Joined Forces.

PCI welcomes the services of Penn Pharma

PCI has joined forces with Penn Pharma to form a global leaderin healthcare manufacturing and packaging services. With over50 years of experience, an exemplary regulatory pro� le, and anexpert staff dedicated to delivering unparalleled service andquality, PCI leads the market in supporting clients’ needs forinnovative pharmaceutical outsourcing solutions.

We’ve combined two exceptional and proven industry leaders into

One Expert Team, One Partner for all your development needs.


Packaging

New Cone Design Leads To A Superior Delivery System for Biotech Drugs.

Interaction between drugs and primary packaging has become an increasingly important topic. In particular, biotech drug substances tend to interact with primary packaging components more easily due to their complex and sensitive makeup. Particular attention should be given to drugs that are filled in prefilled syringes. “In prefillable syringes, the drug is in contact with more materials than in other types of pharmaceutical primary packaging,” says Anil-Kumar Busimi. Busimi is Head of Global Product Management Syringe Business at SCHOTT, and finding new packaging solutions for sensitive drugs is a topic his company has been working intensively.

A quite challenging task: From the end user’s point of view – whether it be a healthcare professional or the patient – a prefilled syringe is the most convenient way to administer an injectable drug. The number of manual preparatory steps is reduced to a minimum, and it is ensured that the patient always receives exactly the right dosage. “From a packaging and drug stability

point of view, however, it is a very complex system. There’s the glass, needle, needle glue, needle shield, plunger, and a silicone oil used as lubricant inside of the syringe barrel. With so many materials coming in contact with the drug, the chances of an interaction between the drug and syringe components increase significantly, and the risk is even higher for sensitive biotech drugs,” Busimi explains.

In response to these challenges, one can think of new syringe designs that decrease this risk. According to Busimi, one way of reducing the number of materials and components the drug comes into contact with is a newly-designed syringe cone with a fluid path made of rubber, including a staked-in needle. A so-called ‘pinch seal’ keeps the fluid path closed during storage. And it’s exactly this newly-designed closure that prevents the drug from coming in contact with the metal needle or the adhesive. As a result, the drug cannot interact with these potential contaminants.

This special design of the glass barrel also eliminates the use of a tungsten pin during the glass-forming process. Heat-resistant tungsten pins are commonly used to form the fluid path or luer channel in syringe barrels. Numerous studies have shown that tungsten residues could interact with sensitive biological drugs leading to protein aggregation. This not only destabilises the pharmaceutical formulation, but also possibly could cause an undesirable immune response from the patient following the injection. The special design of the glass barrel avoids this problem as no tungsten pin is needed to form it – a fact making the syringe entirely tungsten-free.

Yet another issue is the silicone oil used to lubricate the inside of the syringe barrel to ensure smooth injection. This lubricant is seen as an “essential evil” which is required for the functionality of the syringe, but it has also been attributed to unexpected reactions with some biological drugs, leading to protein aggregation or an increase in subvisible particles. The new syringe design allows for baked-on silicone, which significantly reduces the interaction between the drug and the silicone while maintaining the functionality.

Additionally, the design ensures the needle is not in contact with the needle shield, preserving the needle’s sharpness and minimising the risk from the occurrence of ‘hooks’. This, combined with high-tech needle siliconisation, leads to low-penetration force, making injections less painful for the patient.

In an additional effort to ensure packaging and drug integrity, the syringe needle shield can be equipped with a tamper-evident closure. This enables physicians or patients to determine easily if the syringe is still unused.

“All in all, one can say that with this design approach, the drug has the same contact materials [as] a vial – glass and rubber,” Busimi concludes. “This is also important if pharma companies want to switch the packaging from vials to syringes, which normally implies a lot of additional testing for all additional materials. These efforts can be significantly reduced.”

Rise in Sensitive Drug Formulations Requires New Syringe Concepts

Pharmaceutical SystemsSCHOTT AG

Hattenbergstrasse 1055122 Mainz

GermanyPhone: +49 (0)6131/66-1589

Fax: +49 (0)6131/[email protected]

www.schott.com/pharmaceutical_systems

The syriQ™ InJentle. The syringe with limited contact materials just like a vial.

The syriQ™ InJentle offers a tungsten-free design, keeps the

drug separated from adhesive or needle itself and offers

a baked-on silicone to ensure less particles. The thin needle

with no contact to the needle shield enables a safe and

convenient injection. All in all you get a best in class solution

for highly sensitive biotech drugs and sensitive application

fields like e.g. ophtalmic.

The best about it? syriQ™ InJentle with all of these special

features can still be easily integrated in your process.

SHP-8140385_AZ_Injentle_IPI_210x297.indd 1 25.08.14 16:32


Logistics & Supply Chain

Innovation and Tradition We have maintained our traditions for almost 150 years. One in particular: Progress.Berlinger & Co. AG, founded in 1865 in the form of a weaving shop, is a family run company based in Switzerland, in the middle of the idyllic Toggenburg. We, the sixth generation of Berlinger’s to head the company, are proud to be able to carry the values and traditions of our family business into the future. Today the name Berlinger stands for innovative technology to the benefit of our two main business portfolio:

• reliable and easy to use temperature monitoring systems • internationally standardised doping control systems

Above all, Berlinger stands for openness, quality and fairness.

2014 - Expansion into software marketIn June 2014 the Berlinger group expands into software market with the acquisition of Antaris Solutions B.V. With the web-based SmartView application, Antaris Solutions established itself in the market as a provider of innovative solutions for cold chain data management. Today, SmartView is fully validated and one of the world’s most advanced data management system for shipment monitoring and facility monitoring. SmartView is fully integrated with the Berlinger Q-tag CLm doc devices, as well as other ‘best in class’ wireless monitoring devices.

Marked ServedAs one of the leading manufacturers of temperature monitoring systems, Berlinger & Co. AG has provided the pharmaceutical and other industries for over 25 years with reliable and easy to use temperature indicators.Our devices are designed for everyone shipping valuable goods with temperature management issues, including

• manufacturers• logistic service providers• wholesalers in the pharmaceutical supply chain• wholesalers in the food supply chain• and many more...

Every single device is currently used across various industries by hundreds of operators worldwide.

Services OfferedTrust is good – control decisive. Reliable and seamless temperature monitoring is essential for comprehensive quality assurance. The transport of temperature-critical products especially is a challenge for all concerned,

particularly when various companies are involved. Our temperature monitoring systems offer the highest security for quality management. It started first with c h e m i c a l - b a s e d indicators and

moved on to electronic devices. Whether simple indicators, reusable or single-use loggers, dry ice or long-term monitoring, we have the right solution for any requirement. Experience the power of control and ask for more information about our Hardware and Software solutions for significant improvements within your cold chain. It was never that easy to automate your workflow and to meet requirements with our new online data management system SmartView.

Solution Highlights:

Company At A Glance - Company valuesWe are a leading partner globally for secure, simple and lasting doping control, temperature monitoring and special solutions of the best Swiss quality.Berlinger & Co. AG specializes in different niche products. Quality, customer service and customer proximity are the common denominator. As an ideal addition to our comprehensive standard ranges, we offer you the possibility of customer specific products to meet individual requirements for various perishable goods. In the development of new overall solutions and systems, based on special raw and standard materials and technologies, we support our customers with many years of experience and ensure the knowledge with constant trainings of our staff.

Quality AssuredWe value the ongoing quality controls from our competent QM – team as well as external certification institutes and are proud of our different certificates such as ISO 9001:2008, ISO 14001:2004, NIST / ILAC and more.

Ask for professional supportThe optimum temperature monitoring system offers clarity, transparency and documentation for every delivery of your high-quality, sensitive products – easily and securely. Our cost efficiency and its easy handling gives our customers an additional advantage in comparison to conventional products on the market. Contact us for more information, we will be happy to advise you:

Berlinger & Co. AGMitteldorfstrasse 29608 GanterschwilSwitzerland tel +41 (0)71 982 88 11fax +41 (0)71 982 88 [email protected]

1. 24/7 access to authorized users

2. Integrated global view3. Fully automated data collection4. User-defined business and

automated workflow rules5. Secure data storage6. Advanced reporting and

analytics

7. GAMP 5 validation framework8. Remote network management9. Individual adaption to

customer specifications10. Data hosting in high-secure

data center, with back-ups in separate data center

Berlinger - Your Reliable Partner for Hardware and Software Solutions

Experience the power of control using

Berlinger & Co. AG

Mitteldorfstrasse 2 • CH-9608 Ganterschwil

Phone +41 71 982 88 11 • Fax +41 71 982 88 39

[email protected] • www.berlinger.ch

Berlinger USA LLC

222 Turnpike Road, Suite 3 • Westborough, MA 01581 • USA

Phone +1 508 366 0084 • Fax +1 508 366 0087

[email protected] • www.berlinger.com

Berlinger – Your reliable partner for hardware and software solutions.

SmartView is for everyone shipping valuable goods with temperature management issues, including manufacturers, logistic service providers, and wholesalers in the pharmaceutical and food supply chain.

Data is collected through our Q-tag® CLm doc USB family of data loggers designed for easy use in all temperature environments.

SmartView is an award-winning web platform for cold chain optimization that has proven to deliver signifi cant value.

Improve regulatory compliance and enhance Good Distribution Practices (GDP) with a system that allows you to manage excursion acknow-ledgements and causes in a 21 CFR Part 11 database. Reduce time addressing excursion events when they occur and chasing down documents during audits.

Improve process effi ciency by tracking data loggers and their expiry dates. Experience instant access to calibration reports.

Reduce IT time associated with validating and installing software or updates. Avoid common problems with ERP and operating systems due to a 100% online software based on the SaaS model.

Enjoy easy reporting and analysis tools contained within the smartview reports module. Spend less time due to integrated data and world wide access 24/7, automated workfl ow and E-Mail-/SMS notifi cations.



Testo Limited was established in 1983 as the UK subsidiary of testo AG and is based in Alton, Hampshire where we sell the full range of test equipment across the UK and Ireland, both direct and through distributors.

We are a key supplier to the Facility Management and Industrial Maintenance Sectors where we are able to provide the full range of instruments which are critical to the effective and efficient maintenance of premises, and allow compliance with all key regulations.

Testo instruments are widely used in the following sectors: HVAC-R: heating, ventilation, air conditioning and refrigeration. Process Industry: manufacturing industries, service companies and utilities. Food Sector: including food manufacture, transport, storage and retail. Thermal Imaging: for building surveys, maintenance, electrical inspections and production monitoring.

This website is designed to allow easy purchasing of testo products, whilst providing you with vital technical data, new products/promotions and support through our FAQ Forum. Testo instruments cover a range of measurement parameters including: Thermal Imaging, Temperature, Humidity, Velocity, Compressed Air Measurement, Gas analysis, RPM, Pressure, Light, pH, Sound and Instrument Service and Calibration.

Testo Limited Products:We have an unrivalled range of test equipment which is divided into 3 sections:• Gas Analysis - Measuring instruments that analyse

the different flue gas parameters of heating systems or industrial burners, thus helping adjust them to be more environmentally-friendly.

• Hand Held Instruments - Portable instruments to measure temperature, humidity, air flow, pressure, pH values, conductivity, illumination levels, sound level, water activity, and instruments for adjusting refrigeration systems.

• Infrared and Thermography - Non-contact instruments for measuring temperature. These instruments record the infrared radiation being emitted by an object (thermal radiation) and display this either as an individual value or thermal image.

Testo Limited Industries:• Air Conditioning Installation and Maintenance• Building Maintenance, Surveying and Energy Management• Electrical Inspections and Engineering• Energy and Utilities• Facility Management• Food Manufacture, Production, Transport and Storage• Heating Installation and Maintenance• Manufacturing• Refrigeration Installation and Maintenance• Ventilation Installation and Maintenance

This is all supported by our UKAS (ISO/IEC 17025:2005) accredited laboratory where we can calibrate a wide range of instrumentation, from numerous manufacturers, and manage

equipment inventories of varying quantities along with offering fixed term contracts with fast turnaround times. We are able to serve customers throughout the UK and offer a pickup/delivery service in conjunction with our logistics partner UPS, and for customers local to our office in Alton we are able to offer a drop/collect service.

Customer service is a cornerstone of our business management and we have introduced a number of innovative solutions over the last 2 years to improve our speed of delivery and customer communications across product supply, calibration and service. This is a continual process and we are always looking for ways we can improve our performance with further plans for 2014.

Testo AG HeadquartersTesto AG, with its headquarters in Lenzkirch in the Black Forest, is a global leader in the field of portable measurement technology. Worldwide there is approximately 2,450 staff involved in research, production and marketing, with the key objective of developing innovative measurement solutions for our customers, e.g. in the fields of air conditioning and ventilation, food quality, building technology and emission control.

With 30 subsidiary companies and over 80 distribution partners, Testo AG is represented on all five continents, and is a true global manufacturer.

In 2012 Testo AG achieved a turnover of 221 million Euros. The basis for this success was, in addition to the highly qualified and motivated staff, the above average investment in future oriented product development. Approximately 10 percent of the company’s annual worldwide turnover is spent on Research & Development to provide a sustainable and success-oriented step towards the future.

Registered Office:Testo LimitedNewman LaneAltonHampshireGU34 2QJCompany Registration Number: 1688780Telephone number: 01420 544433E-mail: [email protected] Sales CoverageOur technical sales team cover the UK and Ireland, please contact us on 01420 544 433 to arrange an appointment.

We Measure it



Turkish Airlines, which has operated its first international air cargo shipment in 1936, is a 4-star airline company operating flights to more than 260 destinations around the world. The Company, which has been maintaining its cargo services and operations under the sub-brand Turkish Cargo since the beginning of the 2000s, stands as the internationally fastest-growing brand offering air cargo service to the highest number of countries around the world.

Turkish Cargo has been continuing to grow along with Turkish Airlines in recent years. Today, Turkish Cargo is at your service in all over the world with a network reaching more than 260 destinations in 108 countries. We are proud to say that our fleet consisting of more than 255 passenger airplanes and 9 freighters, is one of the youngest fleet amongst the European carriers.

Turkish Cargo, a subsidiary brand of Turkish Airlines, has been able to maintain its ever-envolving and rapid development and continues to raise its cargo and mail shipment volumes.

We cemented trust and dedication in our brand by having six new-generation Airbus A330-200F offering long range services with wide body fuselage. Also three Airbus A310-200F exists in our cargo fleet. Concerning A330-200F additions have enabled Turkish Cargo to make direct scheduled cargo flights to long haul destinations. We, at Turkish Cargo, would like to share our excitement for our new freighter destinations. Thanks to A330-200F’s, we were able to start high quality cargo services to new destinations and increase our freighter cargo capacity in existing destinations as well.

Turkish Airlines is in the fourth rank in the international arena in the world in terms of network, continues to expand its fleet by acquiring Boeing 777 and Airbus A330 planes. As a consequence of our network and fleet expansion policy, we will be able to provide you with closer access to your business partners in many main commercial hubs, and also increased cargo delivery capacity to even more destinations.

In addition to the growth of its cargo network capacity, Turkish Cargo is significantly revising its infrastructural and procedural processes. In September 2013, an additional 10.500 m² of space was added to the cargo center’s service capacity. Additionally, a new 43.000 m² cargo center for Turkish Cargo is still under construction and planned to be operational by 4th quarter of 2014.

Turkish Cargo plans to use a new software solution, instead of TACTIC system used for process management of cargo operations since 1990. The Product iCargo is an integrated new-generation solution suite to handle the cargo management requirements of full freighter carriers, passenger & cargo combination carriers, ground handling agents and airports in the areas of cargo sales &

reservations, terminal operations, mail management & accounting, cargo revenue accounting, cargo revenue management and ULD management; all in a single seamless solution.

Turkish Cargo aims at making Istanbul a logistics hub with a new cargo center of 150.000 m² indoor area which will be built at the third airport in Istanbul, while continuously improving its service quality. We know that our ever envolving quality cargo services is that all what you need while expanding your business globally.

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Products & Equipment Manufacturing Products & EquiPMEnt’s

34


Products & Equipment

+1.216.271.3500 or email us at [email protected]

High-Quality Used Pharmaceutical Processing Equipment!

Your source for surplus Pfizer

equipment!

p. +1.216.271.3500f. +1.216.271.5210

[email protected] www.fedequip.com

8200 Bessemer Avenue Cleveland, Ohio, USA 44127

Techceuticals, the leader in solid dosage training and troubleshooting, welcomes companies to take advantage of their Pilot Manufacturing Lab, which is equipped with moisture and particle analyzers, blenders, mills, wet and dry granulating, tablet presses, coating, and encapsulation. Techceuticals assists customers with equipment selection, formula development, optimization, and training. Visit www.techceuticals.com

p. +1.216.658.8038f. +1.216.916.4383

[email protected] www.techceuticals.com

2917 E. 79th Street Cleveland, Ohio 44104

Federal Equipment Company offers high-quality pharmaceutical processing and packaging equipment at a fraction of the price and lead-time required for new equipment.

Investment Recovery Services. We provide investment recovery services for surplus equipment; whether that equipment is a single item, a complete processing line, or an entire manufacturing facility, including rigging, dismantling, transportation, storage.

Our market knowledge and purchasing ability allows us to pay top dollar for quality used equipment.

Mobile-Friendly Website. Visit www.fedequip.com to review our entire inventory of used pharmaceutical/nutraceutical processing equipment. Our site is mobile-device friendly, allowing our entire inventory to be viewed online anytime, and anywhere.

Ancillary Services. We offer ancillary services such as rigging, dismantling, transportation, and storage needed to effectively manage your surplus equipment while ensuring maximum return on your investment.

Visit www.fedequip.com Today!

• Capsule Fillers • Centrifuges• Coating Pans• Tablet Presses• Dryers

• Fluid Bed Dryers• Fluid Bed

Granulators• High Shear Mixers• Mixers • Lab Equipment

• Tanks• Filters• Roller Compactors• Blister Lines• Bottling Lines

Categories

Federal Equipment Company • 8200 Bessemer • Cleveland, Ohio 44127 • 216-271-3500 • www.fedequip.com

+1.216.271.3500 or email us at [email protected]

High-Quality Used Pharmaceutical Processing Equipment!

Federal Equipment Company offers high-quality used pharmaceutical processing and packaging equipment.


Products & Equipment

Outsource the procurement of equipment for your next clinical trial to Woodley Equipment, with the confidence and knowledge that Woodley can source and deliver the right equipment at the right time to ensure that your trial is delivered smoothly, on time and in budget.

Woodley Equipment Company Limited is a specialist global service provider to the clinical trials industry, with 25 years’ experience, unrivalled levels of customer service, and an extensive range of laboratory and medical equipment available for rental and sale. Woodley is the supplier of choice to many of the largest companies in clinical research. With detailed knowledge of the global equipment market, Woodley will ensure smooth shipments and shorter lead times.

Global SupplierFounded in 1989, Woodley has successfully expanded into a global business. Woodley has multiple company-owned sites and many global partners.

As well as three warehouses and office buildings in the Manchester area of the UK, Woodley has further UK facilities located near to Gatwick Airport, London. Our extensive supplier and distributor networks across Europe extend our European reach further. We also have our own facility outside Boston, Massachusetts, in the USA, and are further supported by numerous partners across North and South America.

Woodley are well placed to provide a fast, responsive, global service to all of our customers.

Complete Clinical Trial Equipment SolutionsWoodley has an ongoing commitment to working closely with our customers to provide personalised services to meet their individual needs. Woodley is focussed on meeting our customers’ expectations and achieving high levels of customer satisfaction. It is through this close partnership working that Woodley has developed a unique range of services.

From the initial enquiry stage to the final conclusion of a clinical trial, a dedicated account manager will work closely with a customer to understand their specific requirements and create a package entirely tailored to their needs. Combining information such as expected trial length, site locations, and equipment requirements, the account manager will source the best value for money equipment solution from a large range of options.

Our highly-qualified technical team includes service engineers, medical electronics technicians and biomedical scientists who are also registered chartered scientists. Their advice and support can minimise equipment downtime, ensuring that your study continues with no delay. Our technical support service includes: advice during initial equipment set-up, advice on maintenance issues as they arise, and troubleshooting issues, including advice on laboratory protocols, the configuration and calibration of medical analysers with the supply of quality control samples, and a multi-lingual 24/7 telephone and email support service.

Our complete service includes:

• Full servicing from initial enquiry to final collection• Dedicated account manager to coordinate and manage all

requests• Total asset management, tracking and service• Global logistics management across hundreds of countries• In-house biomedical and technical support• Global training options• A fully tailored service

Woodley can provide a ‘one-stop’ solution that can bring simplicity to the most complex trial.

Extensive Product RangeWoodley can source, supply and service equipment from any established manufacturer.

Our comprehensive range of laboratory and medical equipment for rental and sale includes: centrifuges, ECG monitoring, patient monitoring, blood pressure monitoring, laboratory equipment, capnography, infusion systems, pulse oximetry, temperature monitoring, point of care, medical refrigeration, medical freezers, ultra-low freezers, spirometry and patient weighing, measuring and examination.

Quality AssuredWoodley Equipment is an ISO 9001:2008 certified company, recognising the quality of administrative and management systems.

Industry Association MembershipWoodley is a member of the Clinical Contract Research Association (CCRA).

Woodley and our team are members of the Institute of Biomedical Science (IMS) and the Institute of Clinical Research (ICR).For more information on any of our products or services, please call our team on 08456 777001, or contact Vijay Manchha on [email protected].

No Substitute for Experience

WE KEEP YOUR

CLINICALTRIALSO N B U D G E T

Blood Pressure Monitoring

Capnography

Centrifuges

ECG Monitoring

Infusion Systems

Laboratory Equipment

Medical Freezersinc. Ultra Low Temperature

Medical Refrigerators

Patient Thermometers

Point of Care

Pulse Oximeter

Spirometer

Temperature Monitoring

Vital Signs Monitoring

Weighing, Measuring & Examination

...we won’t let you down

• Equipment rental/purchase

• Complete worldwide logistics

• Calibration, servicing and technical support available

• Breakdown equipment replaced free of charge

• Global equipment solutions/ outsourced procurement

• No minimum hire/deposit*

Ensuring that your clinical trials arebrought in on budget, we offer full financialmanagement support and a wide range oftailored rental and purchase options.

With over 25 years’ experience wespecialise in global logistics and maintainrigorous cost control across the enterpriseto deliver the most cost-effective solutions.

UK Office: T: +44(0)8456 777001 F: +44(0)8456 777002

USA Office: T: 1-800-471-9200 F: 1-508-625-1721

E: [email protected]

www.woodleyequipment.comFor best value for money visit:

*subject to terms & conditions

JCS-full page-onbudget 9/4/14 15:30 Page 1


Company Key Features

Berlinger & Co. AG• Reliable and seamless temperature monitoring systems• Complete overall solutions (Hardware and Software)• Compliant with various guidelines (FDA, GDP, GAMP 5)• Nearly 30 years of experience in the temperature

monitoring sector• Swiss Quality• ISO 9001:2008, ISO 14001 :2004 certified

Cobra Biologics• CDMO – Contract Development and Manufacturing

Organisation• Comprehensive Service Offering – Cell Line Development

to Supply of IMP• Small molecules, mAbs, Recombinant Proteins, DNA,

Viruses, Phage and Cell Line Derived Products• Pre-clinical, Clinical and Commercial Scale Supply• Aseptic Fill & Finish – Vials, Pre-filled Syringes and

Lyophilisation

Driam GmbH • Continuous mini-batch coater, customized • Batch coating installations in different sizes • Lab coaters – batch or continuous mode • DRIAM laboratory for test and training • Turnkey projects

Federal Equipment• High-Quality Used Pharmaceutical Equipment At A

Fraction Of The Price Of New Equipment• Investment Recovery Services, Whether A Single Item, A

Complete Processing Line, Or An Entire Manufacturing Facility

• Maximum Return On Your Investment• Mobile-Friendly Website, www.Fedequip.Com Shows

Our Entire Inventory Of Used Processing Equipment• Ancillary Services, Such As Rigging, Dismantling,

Transportation, And Storage, To Effectively Manage Your Surplus Equipment

FeF Chemicals A/S• Global regulatory compliance • Manufacture in accordance with the highest GMP

standards on the market, the ICH Guide • Q7 for Active Pharmaceutical Ingredients • High purity products • Analyses according to multicompendial pharmacopoeias

BP, Ph.Eur, USP/NF and JP • Regulatory documentation

GLYCOTOPE GmbH • Technolgies • Contract Research • Analytical Services • Manufacturing Services • Immunodiagnostics

GROUPE SYNERLAB • Contract Manufacturing Organization • Analytical & Galenical Development, ICH stability studies • Manufacturing & packaging • Solid, semi-solid and liquid dosage forms • Aseptic filling • Freeze drying

One 2 One – A Service of Hospira • Injectable product fill – finish manufacturing • Comprehensive development services Phase I - IV • Lyophilization • Vials, Prefilled Syringes and Cartridges, Ampoules • Global regulatory support

Packaging Coordinators Inc • Drug Development and Pharmaceutical Manufacturing• Healthcare Packaging Solutions • Pharmaceutical Commercial Packaging Solutions • Clinical Trial Packaging Services • Developmental Analytical Laboratory Services • Blistering, Bottling, and Cold Chain Capabilities

Rapid Micro Biosystems, Inc. • Quality Control • Microbiology • Automated Environmental Monitoring • Automated Sterility Testing • Automated Bioburden Testing

SCHOTT AG • Glass tubing• Primary packaging solutions• Specialized analytical lab services• Global footprint• Highest international quality standards

Testo Limited• Test and Measurement Instruments• Instruments designed to GxP and 21 CFR Part 11

standards• Temperature and Humidity Monitoring Equipment• UKAS & ISO Accredited Laboratory• Clean Room Equipment

Turkish Cargo • One of the widest global network • High service quality • Istanbul as hub • Expertise in special cargo acceptance and handling • Ever growing cargo capacity

Valsynthese SA • Custom Manufacturing • Hazardous Chemistry • High Energetic Chemistry • Active Pharmaceutical Ingredients & Chemical

Intermediates • Process Development for Chemicals

Vetter Pharma International GmbH • CDMO - Contract Development and Manufacturing

Organization • Aseptic Fill & Finish • Analytical Service • Regulatory Support • Clinical Trial Manufacturing

Woodley Equipment Company• Medical and laboratory equipment rental/purchase• Complete worldwide logistics• Calibration, servicing and technical support available• Breakdown equipment replaced free of charge• Global equipment solutions/outsourced procurement

What if we only hired diabetics to work in the active cold chain? Would they take more care handling health-

care products? We think they would. They know what happens if they don’t get insulin.

Of course we don’t just employ diabetics. But we do share their understanding of the value of what we ship

in our containers.

We educate the members of the active cold-chain on the difference they make to the lives of diabetics

and others who rely on healthcare products. Because people do a better job when they understand

the importance of why they are doing it.

Gunay Hadjimehmed is a diabetic. And his son Mehmet works for us.

Diabetics do it betterenvirotainer.com

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IPI - Outsourcing & Innovation Supplement - 2014

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Transcript of IPI - Outsourcing & Innovation Supplement - 2014