Ipi outsourcing supplement 2013

Outsourcing Supplement

www.ipimedia.com

Issue -1

International Pharmaceutical Industry Supporting the industry through communication

InternAtIOnAl PhArmACeutICAl InDustry 1www.ipimedia.com

DIRECTORS: Martin Wright Mark A. Barker

PUBLISHER:Mark A. Barker

EDITORIAL MANAGERJaypreet [email protected]

BOOK MANAGER: Anthony Stewart [email protected]

BUSINESS DEVELOPMENT:Madalina SlupicOvidiu Terinte

DESIGN DIRECTOR: [email protected]

CIRCULATION MANAGER:Dorothy Brooks

FINANCE DEPARTMENT: Martin [email protected]

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2013 PHARMA PUBLICATIONS

IPI - OUTSOURCING SUPPLEMENT 2013

International Pharmaceutical Industry Supporting the industry through communication

API & FINE CHEMICALS

02 – 03 BACHEM AG

04 – 05 FEF CHEMICALS A/S

06 – 07 GEO® SPECIALTY CHEMICALS

08 – 09 THERAPURE BIOPHARMA INC

10 – 11 VALSYNTHESE SA

CLINICAL RESEARCH

12 – 13 MPI Research

CDMO/CMO

14 – 15 Almac Group

16 – 17 GLYCOTOPE GmbH

18 – 19 Hospira One 2 One

20 - 21 GROUPE SYNERLAB

FC NOVOZYMES BIOPHARMA

OutsourcingSupplement

2013

PACKAGING

22 – 23 Chesapeake

24 – 15 Packaging Coordinators Inc

IBC Pöppelmann GmbH & Co. KG

26 – 27 Presspart Manufacturing Ltd.

28 – 29 Vetter Pharma International GmbH

LOGISTICS & SUPPLY CHAIN

30 – 31 AmSafe

32 – 33 TURKISH CARGO

MANUFACTURING PRODUCTS & EQUIPMENTS

34 – 35 DRIAM

36 – 37 Rapid Micro Biosystems, Inc.

38 – 39 Woodley Equipment Company Ltd

Pharmaceutical and Healthcare Packaging

API & FIne ChemICAls

• 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, nasaland 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 signifi cantly superior to other less pure compounds. If the required product is not in the standard assortment, FeF Chemicals can design customised products. Its fl exible 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 Certifi cates 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 fi rst 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 fi nished products, are carefully analysed in a modern, well-equipped laboratory. Fast and reliable services in documentation, analysis and manufacturing, fulfi lling 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 avery high level of purity of liquid and crystalline productssuch as benzalkonium chloride, strong cetrimide solution,

No Compromise on Quality

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FeF Chemicals

• 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


6

Therapure Biomanufacturing

Contract manufacturing of biologics is more than having superior technology - it’s having experienced people who are passionate, responsive and committed to developing and manufacturing your biotherapeutics to improve patient care. As a fully integrated contract development and manufacturing organisation (CDmO), our people have the scientifi c and technical expertise to successfully deliver at every stage of product development (preclinical, clinical and commercial). Our 130,000 ft2 (12,000 m2) cgmP manufacturing facility meets FDA, emA and hPFB regulatory standards and includes fl exible clinical and commercial production suites.

Development ServicesTherapure appreciates the complexity of the development process. Our range of services is supported by a deep scientifi c understanding of process and analytical development. Our development services include:• Cell line – generation of well-characterised, stable mammalian

cell lines• upstream – development of scalable cell culture processes• Downstream – development of reproducible, scalable and

cost-effective processes for purifi cation of proteins from a variety of biological sources including plasma, transgenic sources and mammalian cell culture

• Analytical methods – bioanalytical assay development and characterisation throughout the product development stages

cGMP ManufacturingWe recognise that a strategic partnership with you is required to achieve complex cGMP manufacturing solutions. We meet your clinical and commercial cgmP manufacturing needs through superior technology and scientifi c expertise. Our cGMP manufacturing services include:• upstream processing – mammalian cell culture capacities

from 50 – 2500 l• Downstream processing – purifi cation techniques including

chromatography, fractional precipitation, pasteurisation and virus removal/inactivation

• qC analytical testing – cgmP analytical laboratories which provide comprehensive analytical testing in support of development and manufacturing

Aseptic Fill/FinishA key aspect of biotherapeutic manufacturing is the delivery of a sterile product to the patient. therapure’s state-of-the-art facility supports aseptic fi ll of your biologic products from preclinical

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stages through clinical trials to commercialmanufacturing.Our aseptic fi ll/fi nishservices include:

• Vials• Prefi lled syringes• lyophilisation

Quality ControlWe provide a full range of quality control services that follow through each stage of your product’s development into commercial manufacturing. Prior to product manufacturing, analytical methods are transferred to therapure’s quality Control department where they are qualifi ed (for Phase I–II clinical programmes) or validated (for Phase III commercial programmes).

Quality AssuranceWe understand that the quality of your product is critical, and our quality assurance team shares your passion. As a therapure client, your product is manufactured according to a rigorous quality management system (qms) that includes an automated deviation and corrective and preventative action (CAPA) management system.

Project Managementtherapure assigns each client a dedicated project manager, who serves as your conduit for communication within the therapure organisation. Our project managers have the management skills necessary to coordinate Therapure’s technical expertise and ensure your project is delivered on time, in full, on budget and within the terms of the agreement.

Highlights of our cGMP Facility• 32,000 ft2 (3000 m2) of cleanroom suites, ranging from Class A

(Class 100:IsO 5) to Class D (Class 100,000:IsO 8)• 13,000 ft2 (1200 m2) of quality control and analytical labs• cgmP warehouse with temperature-controlled storage at

+4°C and low temperature (-20°C to -80°C)• 10 l to 3000 l stainless steel process tanks• 5 clean-in-place (CIP) units for process equipment • Water for injection (WFI) steam-in-place (sIP) capability

We invite you to feel the difference at therapure Biomanufacturing, where the client experience is our passion and patient care is our commitment.

Company ContactDina IezziDirector of marketing & special Projectstherapure Biopharma, Inc.2585 meadowpine Blvd.mississauga, Ontario, Canadal5n 8h9Telephone: (905) 286-6270Email: [email protected]

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Passion for your Process, Product and Patients

Contract manufacturing of biologics is more than having superior technology – it’s having experienced people who are passionate, responsive and committed to developing

and manufacturing your biotherapeutics to improve patient care.

We invite you to feel the difference at Therapure Biomanufacturing, where the client experience is our passion and patient care is our commitment.

Please visit us at

www.therapurebio.com/CDMOOr contact:

Dina IezziDirector, Marketing & Special Projects

Phone: +1 (905) 286-6270Mobile: +1 (647) 234-3395

Email: [email protected]

Therapure Biomanufacturing, a division of Therapure Biopharma Inc. ©2013 Therapure Biopharma Inc. All rights reserved.

Development Services Cell Line; Upstream;

Downstream; Analytical

cGMP ManufacturingUpstream Production;

Downstream Purification

Aseptic Fill/FinishVials; Syringes; Lyophilization

CDMO_AD_IPI_print.pdf 1 9/12/2013 1:20:12 PM


are grown from laboratory-scale to full-scale production. skilled personnel and well-equipped laboratories and a gmP pilot plant are available to meet your needs.

Phosgenation ChemistryPhosgene is a powerful reagent allowing effective access to key reactives such as chloroformates, acid chlorides and carbamoyl chlorides, thereby permitting the clean and effi cient construction of isocyanates, carbonates, carbamides or ureas. A dedicated laboratory for safe handling of phosgene during process development has been newly installed (see picture above). 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 environmentally-friendly working conditions. By using phosgene, Valsynthese is able to offer you both quality and value for money.

Quality you can TrustValsynthese is certifi ed according to ISO 9001 and is cGMP approved by sWIssmeDIC (swiss health Authority). Continuous improvements of our quality and manufacturing processes are a benefi t 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 satisfaction. Valsynthese regulatory and cgmP services include process validation, preparation of DmFs and stability testing according to ICh guidelines. Various DmFs have been submitted to european and Japanese health authorities.gmP Facilities

• Two multipurpose plants with reactors from 500 to 4000 litres• high-pressure reactor up to 25 bar (2500 l)• Centrifuges, fi lter nutsche dryer, vacuum mixing dryer• Phosgenation plant with phosgene generator (40 kg/h)• Cleanroom plant for pharmaceutical intermediates preparations• Continuous manufacturing plant for nitroglycerin, pharma

grade

Valsynthese 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 fi rst samples to the bulk quantities of kilograms and tons, you have one partner to speak with. With Valsynthese, your chemistry is in safe hands.

Contact Infohelmut ZimmermannValsynthese sASociété Suisse des Explosifs GroupFabrikstrasse 483900 Brig, switzerlandTel: +41 27 922 71 11; Fax: +41 27 922 72 00E: [email protected]; W: www.valsynthese.ch

Valsynthese

10

Valsynthese is a subsidiary of Société Suisse des Explosifs. Since its foundation in 1894, the group has acquired broad experience in the fi eld of civil explosives, which has developed into expertise in hazardous and high-energy chemistry for the pharmaceutical and fi ne chemical industry. Today Valsynthese is a contract manufacturing organisation (CmO) offering solutions for your chemical needs wherever 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 a

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.

Valsynthese is mainly active in the pharma business sector, 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 & fl avours and performance materials. These are mostly chemical intermediates based on the technological platform Valsynthese specialises in.

Valsynthese 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 fi ts to the customer’s needs.

High Energetic and Hazardous ReactionsValsynthese has extensive expertise and capabilities in the fi eld of high-risk chemical reactions and 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 customers and stakeholders, Valsynthese strives to adapt the technology in such a manner that a reliable, cost-

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MARKET SERVED

COMPANY AT A GLANCE

SERVICES OFFERED

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, your know-how is protected to the highest standards. your ideas

12

ClInICAl reseArCh

infrastructure, and cutting-edge technology in which we have heavily invested. We recognise that our sponsors need to make vital decisions based on solid data that will have important implications for their company as well as the world’s healthcare portfolio. mPI research takes its role in that process very seriously.

Our dedication to being a solutions-oriented partner goes beyond the modern facilities, innovative procedures, and scientifi c expertise. Our team of nearly 1300 employees, ranging from technicians to veterinarians, pathologists, and senior-level scientists, is there for our sponsors to ensure all their needs are met. We are proud of our long-term relationships with our existing sponsors and are equally excited about building partnerships with new ones. most important, we are committed to the success of all our sponsors, ensuring each the same level of scientifi c excellence, technical quality, and passion for their success, irrespective of the size and/or number of studies we conduct for them. each and every employee welcomes the opportunity to show sponsors that they made the right choice in selecting mPI research as their drug development partner.

Company Name: mPI researchAddress: 54943 North Main Street, Mattawan, Michigan, 49071, USTel: +1.269.668.3336 Fax: +1.269.668.4151Web: www.mpiresearch.comKey Contact: Joan mannersEmail: [email protected]

mPI research is the largest single-site full-service contract research organisation (CrO) in the world. Its global headquarters are in mattawan, michigan. With over 1,000,000 square feet in one location, it serves the pharmaceutical and biotech industries in meeting their early drug/device development needs. Sponsors benefi t from the company’s well-developed understanding of today’s therapeutic and regulatory environments, and this knowledge is anchored in the strength of scientifi c experience at MPI Research.

As a full service CrO, mPI research partners with biopharmaceutical, medical device, animal health, and chemical companies globally in meeting their preclinical research and development needs. Scientifi c knowledge and experience, integrity, trust, teamwork, and dedication to strong and enduring sponsor relationships are the defi ning attributes that characterise us as a high-performance, high-quality organisation committed to bringing safer and more effective products to the world. Our open and responsive culture is evident in the collegial, collaborative atmosphere where we conduct thousands of drug safety, discovery, bioanalytical, and analytical studies each year, taking pride in being selected by companies who want a CrO partner on the leading edge of drug development. Committed to excellence in quality across all services and at all levels, mPI research operates in full compliance with international, federal, and state regulatory agencies. Our regulatory and quality assurance programmes include:

• AAAlAC International accreditation• Compliance with FDA, ePA, usDA, emeA, OeCD, ICh,

and JmhW guidances and regulations• Dedicated quality Assurance, with registered qA

professionals (rqAP-glP)• Continuous operational auditing, including subcontractors• Ongoing customised inspection of glP studies and reports• Lean Six Sigma

Our sponsors not only benefi t from our familiarity with regulatory agencies worldwide, but are also able to take full advantage of our state-of-the-art facilities, robust

MPI ResearchBRIEF HISTORY

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CANDIDATE SELECTION

LEAD OPTIMIZATION

DRUG EFFICACY

TARGET ID & VALIDATION

DRUG SAFETY

ANALYTICAL/BIOANALYTICAL

Beyond Expectations.MPI Research is more than your typical CRO. We are leading the way in drug and device development, from discovery through early clinical testing.

Beyond Transactional.At MPI Research, our broad scope of preclinical and early clinical services are supported by excellent scienti� c expertise. As the world’s largest preclinical research CRO in one location, our depth of experience enables us to o� er a collaborative environment, the knowledge base to handle all types of studies, and the capability to smoothly transition from preclinical to clinical testing. Our Sponsors appreciate our ability to be their strategic partner in moving their drug or device along the development pathway.

Ready to Go Beyond?

GOING BEYOND

For more information, visit www.mpiresearch.com

210x297 MPIdna_IPI.indd 1 2/12/13 10:29 AM

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distribution activities.

Clinical TechnologiesAlmac has been a leader in providing interactive voice and web response (IVr / IWr) technologies since 1995. through our industry-leading IXrs® integrated (IVr / IWr) technology, we offer fl exible solutions for patient enrolment, screening, randomisation, drug assignment, inventory management, patient compliance, electronic patient-reported outcomes, and adaptive trials.

Commercial ServicesWe offer integrated commercial services for all drug products from manufacturing, testing and packaging to end-user distribution. specialising in the manufacture and primary packaging of solid oral-dosage forms and with a wide range of packaging technologies, we also provide customised secondary labelling and packaging for biopharmaceutical products. Integrating eu import testing, packaging, qP release and distribution, we can assist non-european companies launch their orphan drug or niche products into the european marketplace.

New Developments:Almac have completed their gmP manufacturing facility expansion: highly potent API (Phase I to commercial) can now be manufactured in batches up to 150kg. We are now in a unique position to offer all the services required to manufacture [14C]-labelled antibody drug conjugates, making a real impact to fi rst-in-human study programmes.Almac has also experienced growth through the recent creation of a new 13,400-sq.ft. formulation development facility and analytical laboratories. this facility focuses on the development of tablet and capsule formulations for new drugs which are in the early stages of development, and which have not yet reached the market. Almac also invested $10m to develop a 100,000-sq.ft facility in Pennsylvania, which was audited and approved by the FDA in January of this year. This has also directly benefi ted Almac in Craigavon, now tasked to produce billions of tablets and capsules in its state-of-the-art facilities.Our clinical service offering has been further expanded by the introduction of contained drug-handling capabilities both in europe and us thus enabling Almac to now dispense and bottle solid dosage products. www.almacgroup.comE [email protected]

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organisations alike, providing consulting services such as drug supply management and qualifi ed person release that enhance and supplement the global clinical supply chain, alongside our core manufacturing, packaging and

Almac has the most comprehensive range of integrated drug development services available to the pharmaceutical and biotech industry.Over 600 companies worldwide, including all the market leaders, use our services, testament itself to the quality, innovation and effi ciency of our business as proven over the past 30 years.

Almac’s range of services includes:Biomarker Discovery & DevelopmentOur services range from pre-clinical biomarker discovery, through to full companion diagnostic development and clinical test delivery from our ClIA laboratory. We have a portfolio of proprietary discovery arrays and extensive experience and expertise working with formalin fi xed paraffi n embedded (FFPE) tissue.

API Services & Chemical DevelopmentWe provide services for all stages of drug development for small molecules, potent and cytotoxic compounds, and peptides. Our services include API supply, drug product development, stable and radiolabelling, solid state services and biocatalysis. We also offer rapidd™, a lean, effi cient, integrated package from selection of pre-clinical candidate to Phase I regulatory submission.

Pharmaceutical DevelopmentOur team of highly-skilled scientists can develop your clinical candidate into an optimum formulation, and manufacture drug product for all phases of clinical trial supply (Phase 0 – Phase IV). With bespoke, in-house engineered containment solutions, we can develop and manufacture batches of solid, oral-dose drug product containing potent API to an operator exposure level (OEL) of 0.03µg/m3.

Analytical ServicesOur analytical team delivers comprehensive solutions supporting drug substance (API) and drug product development programmes, including CMC regulatory fi lings. Additionally we provide analytical and microbiological testing solutions for clinical and commercial drug product supply.

Clinical Trial SupplyAlmac has over 20 years’ experience in clinical supplies and have successfully packaged, distributed and delivered supplies for thousands of clinical protocols. We work with small and large

ALMAC Partnering to Advance Human Health

CDmO/CmO

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SERVICES OFFERED

SERVICE ALMACWhy is Almac’s drug development service unique?

Almac has a broad range of services from research through

pharmaceutical and clinical development to commercialisation

of product. This includes niche services such as genomics,

radiolabelling and biocatalysis which, coupled with our continual

commitment to exceptional innovation, makes our service

truly unique.

Unrivalled range of services

Niche offerings

Truly innovative

Depend on Almac for an ace service.

> Biomarker Discovery & Development > API Services &

Chemical Development > Pharmaceutical Development > Analytical

Services > Clinical Trial Supply > Clinical

Technologies > Commercial Services

almacgroup.comEurope: T +44(0)28 3833 2200USA: T +1 (215) 660 8500 E [email protected]

New: Almac’s Mobile Website

Visit us at:

CPhI / ICSE Hall: 4.2

Stand: 42L08

IPI.indd 1 16/08/2013 15:34

CDmO/CmO

• Design and conduct of immunomonitoring assays to support clinical development

• Immundiagnostics

Products• Fsh-geX™ (glycol-optimised follicle-stimulating hormone)

– end of Phase II• Pankomab-geX™ (anti-tumour muC1 antibody) – Phase

IIb• CetugeX™ (glycol-optimised egF receptor antibody) –

Phase IIb• trasgeX™ (glycol-optimised 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

glycotope was founded in February 2001 by Dr steffen goletz, and today employs 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 four mid- to late-stage projects. the main technologies are the glycoBodytm technology, creating new glycoepitope targeting antibodies for treatment of cancer, and GlycoExpressTM, for glyco-optimising a broad variety of biopharmaceuticals resulting in biosuperiors of e.g. already marketed compounds. glycotope and its manufacturing arm glycotope Biotechnology showed competence in developing compounds from very early- to late-stage, contributing signifi cant improvements to healthcare and creating company value. Based on glycotope’s portfolio and business concepts, the participation of Hexal founders Thomas and 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; the world’s broadest, most potent and

validated glycol-optimisation technology for improvement of the vast majority of antibodies and protein biopharmaceuticals

• GlycoBodies; therapeutic antibodies against glyco-epitopes• GlycoProcess; fermentation and purifi cation for optimised

glycoprotein production

GLYCOTOPE “Turning Glycomics into Health”

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Technical ServicesOne2One™ is able to manufacture injectable products in a broad range of delivery systems, including:• Vials, bottles and ampoules• Glass and plastic prefi lled 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 fi ll/fi nish

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Corporate Descriptionhospira’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 qualifi ed personnel in every world-class facility ensure quality, capacity and security of supply.

One 2 OneA Service of Hospira

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• CTM / registration batches• Lyophilisation• Sterile powder fi lling• Terminal sterilisation• Multilingual packaging and labelling• Cold chain management

COMPANY AT A GLANCE

For questions regarding our services and capabilities, the One 2 One team is available to take your call at:

Main: +1-224-212-2267Europe: +44 (0) 1926 835 554Japan: +81-(0)6-4560-2074Australia: +61 8 8234 2660

Parenteral Contract Manufacturing Service of Hospira

KNOWLEDGE | EXPERIENCE | EXPERTISE

Let’s talk about the benefits of

Complementary Capabilities

Let’s talk more

Call +1-224-212-2267 or +44 (0) 1926 835 554

or e-mail [email protected]

iCSE/CPhI 2013AAPS 2013BIO-Europe 2013PDA Europe Universe of Pre-filled Syringes & Injection Devices 2013

Complementary Complementary Complementary Complementary Complementary Complementary Complementary Complementary Complementary Complementary

Let’s talk about the benefits ofLet’s talk about the benefits of

Complementary CapabilitiesComplementary Complementary

Let’s talk more

Call +1-224-212-2267 or +44 (0) 1926 835 554

or e-mail [email protected]

McPherson, USA

Zagreb, Croatia

Liscate, Italy

NORTHAMERICA EUROPE

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

Hospira, Inc., 275 North Field Drive, Lake Forest, IL 60045 P13-4132/R1-210x297-Sep.,13

CDmO/CmO

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operate to the highest local standards and common quality standards and systems; many are accredited to IsO 9001: 2000 and Ps9000.

Total Product CapabilityWe provide our customers with an unrivalled range of printed products. In addition to folding cartons, labels and leafl ets, we’ve introduced many new formats addressing both the legislative and consumer requirements of the sector, for example: re-sealable leafl et-labels; our unique Easipak™ leafl et-cartons; and credit-card-sized booklets. Chesapeake’s recent acquisition of French specialist, Pharmapost, has further extended the range of leafl et styles and formats available to customers, including double and triple-folded reel leafl ets.We continuously evaluate technical developments in both processes and materials. Our unmatched investment programme has benefi ted all our global operations. As well as new generation production equipment, we are committed to product innovation to help our customers develop and extend their markets.

Complete Systems and SolutionsChesapeake supports its global manufacturing capability with impressive design facilities and optimised supply services. the Chesapeake ‘solution set’ combines the best of what we offer: innovative packaging design, seamless and secure manufacture, and a robust supply chain partnership. Our independent design studios offer clients a dedicated artwork facility equipped with the latest technology. this global facility provides outstanding market-specifi c design solutions that help to build strong brands. Our services include a full artwork management consultancy and all forms of proofi ng, as well as quality control and expert proofreading resources.Our capability extends from initial concept to full artwork management services including revision management, through to the complete management of the supply chain. using e-VmI systems we aim to dynamically drive the rationalisation of stock and minimise obsolescence as well as compressing lead times through collaborative planning.

A network to rely onEmail: [email protected]: www.chesapeakecorp.com/pharma

philosophy is actuallyfounded on localcapability andlocal supply. We can confi dently satisfy stringent quality standards and offer asingle-source, multi-sitesolution for allpharmaceutical packaging. All our sites

A global operation with a local touch, Chesapeake Pharmaceutical and healthcare Packaging has over 20 strategically located manufacturing facilities in the us, europe and Asia.We offer an unrivalled range of printed products including folding cartons, labels and leafl ets. Our service also extends to sophisticated anti-counterfeiting measures and all aspects of artwork management. We supply many of the world’s leading pharmaceutical companies, as well as many more specialist niche businesses.

Chesapeake is intent on expanding its international network of strategically located facilities across the world. “Our aim is to introduce new products to market as quickly and cost-effectively as possible,” said Bobby O’Connor, global sales & Key Account Director. “naturally, we offer absolute security of production, providing customers with single- or multi-point service and the assurance of both multinational and local supply.”In europe, Chesapeake is the leading pharmaceutical packaging provider, producing an unrivalled range of components across seven countries. recent investment in our Polish operation has strengthened the range of labels, cartons and leafl ets it offers as well as our presence into central europe. In the us, we are a leading supplier of pharmaceutical inserts and our cgmP-rated facilities also supply a specialist range of labels and cartons. In september 2011, we completed the acquisition of Cortegra, a leading producer of pharmaceutical leafl ets, labels and cartons. this strengthened our service to customers and added both size and scale to our us operations.In Asia, our state-of-the-art 7500m² factory in Kunshan, China manufactures an extensive range of cartons, labels and leafl ets. this facility employs innovative practices and systems to provide a high level of manufacturing security. It is also the fi rst factory outside Europe to be certifi ed to the exacting pharmaceutical manufacturing standard, Ps9000. Borderless Quality AssuranceDespite the fact that Chesapeake Pharmaceutical and healthcare Packaging provides a truly multinational service, our

ChesapeakeWorld-class Pharmaceutical Packaging

BETTER BY DESIGN

SERVICES OFFERED

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Pharmaceutical and Healthcare Packaging

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COMPANY AT A GLANCE

Your customers expect total care!You should expect nothing lessof your suppliers!

We protect and promote the world’s great brands

R

www.chesapeakecorp.com/pharma

When it comes to pharmaceutical packaging, we aim to meet every expectation.

We offer an unmatched range of products and

services through a global network of 23 dedicated

factories. Valuable too, our drive for creativity

shows in innovative solutions such as our unique

Easipak™ leaflet-cartons - just one of the many

ideas we have to offer. We ensure total security

of supply - locally, regionally and internationally.

We also take a holistic view of our service

responsibility, from sophisticated anti-counterfeiting

technology to supply chain management.

Chesapeake …a global leader in pharmaceutical packaging - leaflets, labels, cartons and a whole lot more.

CSK_PMPS_Jan13.pdf 31/1/13 16:15:36

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Packaging Coordinators,Inc.

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PCI is a global healthcare packaging and analytical services provider that partners with pharmaceutical and biotech manufacturers to increase their products’ speed to market and opportunities for commercial success. Working with a wide range of clients from small ‘virtual’ companies to the world’s largest pharmaceutical fi rms, PCI provides services to support customers’ packaging needs throughout the product lifecycle – from Phase I clinical trials through to commercialisation and ongoing supply. these wide-ranging capabilities afford its customers agility in a dynamic market, with the fl exibility to adapt quickly to changing demands and enable them to capitalise on market opportunities.With expertise in clinical trial packaging and global logistics support, analytical services, qualifi ed person consultancy and commercial packaging and storage, the company offers the industry proven experience, combined with continued technology investment and a commitment to exceptional service and quality. The business has a global footprint through strategic locations in the usA and uK, with 12 state-of-the-art packaging, storage and distribution facilities, and more than 1500 highly-trained associates worldwide.PCI’s gateway to europe and Asia is located in hay-on-Wye, Herefordshire. Expanding rapidly to meet demand, it recently enhanced its capacity with a 23,000 sq. ft. storage and distribution facility and a 4000 sq. ft. speciality pharma centre dedicated to potent compounds.

Clinical Trial ServicesPCI provides expertise in clinical trial supply, offering packaging design and development, global distribution, storage and packaging services to meet the needs of today’s clinical trials. the company also offers its clients a range of value-added services including qualifi ed persons, logistics planning, comparator sourcing, label production and language translation, as well as over-encapsulation. skilled associates collaborate with clients to deliver study materials to investigational sites effi ciently and effectively, helping to successfully avoid the challenges and roadblocks inherent in drug development. the company’s clinical trial services meet the needs of ever-changing global clinical programmes with fl exible systems that focus on timely and accurate delivery. It offers scalable development-to-commercialisation solutions for the entire product lifecycle, from Phase I trials to commercial launch and post-approval studies.

BRIEF HISTORY

SERVICES OFFERED

Laboratory ServicesPCI’s laboratory services provide reliable data to support customers’ product development, assisting manufacturers with early-phase analytical services complemented by ongoing testing services over the lifetime of the product. Customers rely on the company’s fl exibility and responsiveness to help them navigate the spectrum of drug development. PCI’s services include method development, method validation, analytical testing, stability storage and testing, import testing and microbiological testing. The company offers extensive resources, including the convenience of laboratories in both europe and north America staffed with analytical chemists accredited in the most comprehensive laboratory standards.

Commercial ServicesPCI is a leader in the commercialisation of new medicines, meeting the varying needs of each customer and each market it serves. the company’s global insights help provide packaging solutions that differentiate products in competitive markets, delivering medicines to patients creatively and effectively. PCI’s experience in commercial product launch is unparalleled, covering packaging design, development and branding, as well as patient compliance and adherence solutions, launch management services and regulatory support.PCI adapts to the unique requirements of each market, from brand and generic ethical pharmaceuticals and biotech medicines, to over-the-counter pharmaceuticals, animal health products and consumer healthcare products, as well as specialised requirements for medical devices and specialty products.

Contact DetailsPackaging Coordinators, Inc.Wye Valley Business Parkhay-on-Wyehr3 5PguK

Tel: +44 (0) 1497 820829Web: www.pciservices.comE: [email protected]

© Copyright 2013 Packaging Coordinators, Inc. All Rights Reserved.AndersonBrecon (UK) Limited trading as Packaging Coordinators, Inc. is a company registered inEngland and Wales with company number 02543975 and VAT registration number GB 549 7026 19whose registered of� ce is at The Broadgate Tower, Third Floor, 20 Primrose Street, London, EC2A 2RS

Global Reach with 14 packaging facilities in North America and Europe

Clinical Trial Services

Commercial Services

Laboratory Services

www.pciservices.com

One Expert TeamTwo Industry Leaders Have Joined Forces.

Introducing the new Packaging Coordinators, Inc.

We’ve brought together the services of Packaging Coordinators, Inc.

and AndersonBrecon to form a global leader in healthcare packaging.

Over 50 years of experience, an exemplary regulatory profile,

and an ongoing dedication to significant investment in cutting

edge technologies ensures our customers a packaging partner

they can trust to deliver unparalled service and quality. The new

PCI leads the market in supporting clients’ needs for pharmaceutical

packaging services and innovation.

We’ve combined two exceptional and proven industry leaders into

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

PCI_IntroFINAL_PMPS.indd 1 7/25/13 9:59 AM

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PRESSPART

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Presspart manufacturing is the world’s leading supplier of metered-dose inhaler (mDI) components, including plain and internally-coated metal cans and plastic actuators to the pharmaceutical market.Presspart’s product portfolio includes deep-drawn aluminum and stainless steel metered-dose inhaler cans as well as precision plastic-moulded metered-dose inhaler actuators, multi-component sub-assemblies and fi nished devices, predominantly for the respiratory drug delivery and medical device markets.Presspart also offer our customers an extensive range of dispenser actuators for various containers and valves across the pharmaceutical market. suitable for mechanical spray pumps and aerosol valves, our dispenser actuators can be used for oral, aural and topical applications. the range also includes caps for aluminium cans.Presspart also offer a wide range of cans and actuators for metered-dose inhaler devices, with standard metered-dose inhaler can sizes of 10ml, 14ml, 17ml and 19ml. Presspart also offer a number of custom solutions, providing complete fl exibility for our customers. these include the ability to have sleeved canisters, ensuring the same component can be used for lower dosing requirements. Presspart also have the ability to produce specialist smaller canisters, and our canister range fi ts all valve sizes and is compatible with gasket and O-ring sealed valves.Presspart manufacture a wide range of metered-dose inhaler actuators for solution and suspension formulations, containers (glass bottles/metal canisters) and valves across the market. Presspart also have the ability to design and manufacture bespoke actuators based on customer requirements. Presspart’s actuators are also all manufactured under cleanroom conditions at our factory in spain.some key features of Presspart mDI inhaler actuators include:

• Tight dimensional tolerances to ensure accurate fi t and position of canister and valve – reproducible over multiple cavities and multiple batches

• Consistent manufacturing processes – which ensure continuity in batch production

• Robust – will withstand temperature extremes and repeat actuations (200+ doses)

• highest quality resins and colorants• Stem block is designed for effective valve stem fi t – no

leakage, no failureBoth the quality of the active ingredients and the reliability of the packaging and delivery systems are crucial to the health of

PROFILE

it is easy to see why Presspart are the partner of choice for some of the biggest names in the pharmaceutical industry.Presspart’s world-class manufacturing capability ensures high-quality products to meet rigorous global customer and regulatory demands, as well as cost leadership through improvement programmes. Presspart are committed to continuous innovation, providing customers with access to leading-edge technologies and next generation solutions to meet their needs in an increasingly demanding global market. An example of this innovation is Presspart’s Plasma technology for pmDI cans, which enables customers to meet the most challenging requirements for formulations, compatibility and fi nal product performance.As part of their commitment to innovation, Presspart have created an Inhalation Product technology Centre (IPtC). the IPtC will deliver the capabilities to support new product developments, and strategic initiatives with our customers. Presspart have an in-depth technical understanding of the products we manufacture, as well as assembly. the IPtC will enhance those capabilities and deliver a customer-focused device development and drug-related performance understanding.Key Capabilities of the Inhalation Product technology Centre will include: • Inhalation device design, concept and development• Device customisation and enhancement to meet formulation

requirements• Device performance / interaction studies with the drug product• Device meteorology and specifi cation development• Component / device evaluation, screening and optimisation• Inhalation product testing support• multi-region regulatory supportthe new Inhalation Product technology Centre will be based at the Presspart Blackburn headquarters. The facility includes extensive offi ces, research and laboratory facilities, as well as a dedicated team to work within the Inhalation Product technology Centre.Presspart have manufacturing facilities in marsberg germany, Blackburn uK and tarragona spain, and are part of the heitkamp and thurman group, the leading global partners for the supply of world-class precision-formed components in both metal and plastic. With 19 medium-sized manufacturing companies, the group performs services for the most demanding customers around the world.

Contact InformationPresspart manufacturingWhitebirk Industrial estateBlackburn, lancashireBB1 5rFE: [email protected]: +44 (0) 1254 584131W: www.presspart.com

patients. It’s Presspart’s precision that makes all the difference here, and that’s why it’s the company’s most important guiding principle. With more than 40 years’ experience and a worldwide reputation for competence, quality and innovation in the manufacture of metered-dose inhaler components,

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72033 Presspart advert 28/9/12 14:41 Page 1

Key steps include compounding, fi ltration, preparation of primary packaging materials, and fi lling. Additional steps may include lyophilisation, terminal sterilisation, and visual inspection. Precise indicators are also generated for the master batch record.

Analytical ServiceValidation of all raw materials, bulk solutions, in-process materials, and fi nished product is determined by sophisticated analytical techniques. Vetter’s analytical quality control staff also provides expert support for the critical transfer of analytical methods. All instruments and methods are aligned with current international requirements.

Regulatory SupportVetter supports you through all phases of regulatory submission. Expert technical writing and dossier preparation begins in parallel with clinical production to streamline the regulatory submission process, supported by our in-depth knowledge of global regulatory requirements, including FDA, emA, PmDA (Japan), and rP (germany).

Vetter is a leading independent contract development and manufacturing organisation (CDmO) that specialises in the aseptic fi lling of syringes, cartridges and vials. The company has extensive experience with biologics and other complexcompounds, including monoclonal antibodies, peptides, interferons and vaccines. Vetter supports your products from preclinical development through global market supply. the company offers state-of-the-art technology and innovative processes to increase product quality and maximise API yield.Vetter’s international success arises from its three interdependent service divisions:

• Vetter Development Service specialises in taking compounds from preclinical development through Phase lll.

• Vetter Commercial Manufacturing provides Phase lll manufacturing through global market supply.

• Vetter Packaging Solutions matches drug substances with the appropriate drug delivery system for a product’s life cycle.

batches; stabilitybatches; validationbatches; methodtransfer and scale-upfor commercialmanufacturing.

Clinical TrialManufacturingFollowing confi rmation of successful process scale-up, clinical production begins.

In 1953, helmut Vetter founded a modest pharmacy in ravensburg, germany. reincorporated as Vetter Pharma-Fertigung gmbh & Co. KG in 1984, the company has grown from a local drug packager to an international CDmO that serves the world’s top10 pharma/biotech fi rms and emerging companies alike. In 2011, Vetter launched its fi rst US facility, an expansion of its Development service division, to meet the growing need for early-stage product support in north America.

Markets Servedmajor markets: usA, europe and Asia

Filling Your Clinical Development NeedsVetter Development service supports your drug-development projects, from inception to market launch. Our Chicago facility, along with our existing sites in Germany, provides clinical manufacturing from preclinical development through Phase II, with scale-up and transfer to our commercial manufacturing facilities. the Chicago site is designed specifi cally for supporting the development of your early-stage, high-value biopharmaceuticals. Vetter Development Service fi lls clinical trial materials under strict aseptic and GMP standards. thanks to state-of-the-art technology and innovative processes, we help increase your API yield.

Vetter Development Service Provides You With:Formulation SupportIn early clinical development, preformulated compounds may sometimes require a higher level of support prior to process development. Vetter can work side by side with your development team to optimise preformulated API for clinical trial – as well as identify the strongest of several prequalifi ed candidate drug formulations through compounding and fi ltration studies, API/material compatibility analysis, and lyophilisation cycle testing. transfer, optimisation of analytical methods, and validation are also provided.

Vetter Development ServiceBRIEF HISTORY

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ProcessDevelopmentthe goal of process development is toenable fast, smoothtransfer of your project to commercial manufacturing.tailored to yourproduct’s specifi c requirements, process development servicesinclude: siliconisation methods studies forthe appropriate drugdelivery system; fi lter compatibility testing; lyophilisation cycle development if required; feasibility studies; engineering

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Learn more at BIO-Europe 2013 International Partnering Conference in Vienna, Austria at Booth # 53.

If you’re going to market in a prefilled syringe, shouldn’t

you go to clinic in one?If your goal is to differentiate your product at launch with a prefilled syringe or cartridge, it’s only logical to start clinical development that way.

• Take advantage of our fully-automated clinical filling of syringes, vials,

and cartridges in 2 sites: Chicago and Germany.

• Benefit from our expertise in process development, lyophilization,

formulation support, analytical method transfer, and validation.

• Profit from our experience in ICH stability testing, scale-up in Phase III,

and seamless transfer to Vetter Commercial Manufacturing.

• And finally, we will support you at each step of regulatory submission.

We can help move you from a vial to a prefilled syringe or cartridge – talk to us today.

Vetter Development Service I Vetter Commercial Manufacturing I Vetter Packaging Solutions

A unique blend of expertise for clinical manufacturing

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

Answers that work

www.vetter-pharma.com

Vetter_Ad_Drug Devel.Delivery210x297_Sept.indd 1 20.09.13 09:49

lOgIstICs & suPPly ChAIn

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Simple, Safe and Fast

We deliver your temperature-sensitive consignments of medicines to the destination point on time and with high safety. • effectively-used simple procedure • easy booking with advanced communication methods • Trained, certifi ed and specialist personnel • the shortest possible transit period 24/7 monitoring by CCTV camera system• Carriage without breaking the cold chain • Tracking all your consignments from the fi rst to the fi nal

process

TURKISH CARGO

In this period of sustained reductions in business volume or stagnation in the global air cargo market, turkish Airlines Cargo has continued its rapid growth. Worldwide, air cargo business volume fell roughly 1% in the years 2011 and 2013. Projections for 2013 estimate that the global market will continue to shrink or, at the very best, remain stable, without exhibiting any growth over the previous year. With this, despite such a negative outlook for the world air cargo market business volume, turkish Airlines cargo is quickly advancing toward its target of growing by 20% in 2013 based on tonnage carried.turkish Airlines is undergoing a period of notable progress. Over the past eight years, the company tripled the size of its fl eet, its service capacity, and the number of destinations it serves. Today, Turkish Airlines Cargo has a fl eet of more than 230 aircraft — nine of which are cargo planes — that fl y to more than 104 countries worldwide. The company runs direct fl ights to more countries than all other airlines in the world.Currently, Turkish Cargo operates 47 freighter destinations worldwide. moreover, the company uses the belly cargo capacity of Turkish Airlines network to more than 240 destinations in 104 countries.

Cool-chain SpecialistturKIsh CArgO performs cargo transport to over 240 cities and also organises truck trips to over 1000 points where we do not fl y yet. Besides, your pharmaceutical consignments are delivered to the required point, at the required temperature range and at the required time thanks to our over 70 sPAs (special Prorate Agreements) and 150 and more Interlineconnections around the world.

BRIEF HISTORY

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EUROPE (11)

ASIA (16)

MIDDLE EAST (10)

AFRICA (10)

VIENNA

DHAKA

CAIRO

ALGIERS

HELSINKI

TBILISI

ERBIL

ACCRA

FRANKFURT

HONG KONG

TEL AVIV

MITIGA

BUDAPEST

NEW DELHI

AMMAN

CASABLANCA

MILAN

MUMBAI

BEIRUT

LAGOS

MAASTRICT

ALMATY

JEDDAH

KHARTUM

MADRID

BISHKEK

RIYADH

NAIROBI

STOCKHOLM

SEOUL

DUBAI

JOHANNESBURG

ZURICH

BANGKOK

KUWAIT

ENTEBBE

MINSK

TASHKENT

TEHRAN

KIGALI

KIEV

GUANGZHOU

SHANGHAI

SINGAPORE

33


Our Difference is Your Privilege the privilege of shipping your cargo through temperature-controlled containers by the number one carrier among all airlines around the world that fl ies to the highest number of countries, and the promise of delivering your cargo to the target without breaking the cold chain through monitoring the temperature at all points.

• 10 years of specialisation in consignments of medicines• handling service for temperature-sensitive consignments of

medicines at over 95 points • Specialist and certifi ed personnel• 65% market share in consignments of medicines to be

delivered both from and to turkey • Average annual carriage of 180,000 kg vaccines and 120,000

kg medicines, a total of over 1,000,000 kg carriage of all medicinal products.

Our certifi ed and specialist personnel act with the awareness of your consignments of temperature-sensitive medicines etc. and execute all procedures with such an approach.

• First-class cold-chain service for your high-value pharmaceutical products.

• Careful carriage and effective cool-chain management • Maximum care and dedication for your medicinal products

which are extremely important for human health • regular tracking services. • Protection from extraordinary weather conditions that might

occur during carriage and storage. • Special temperature-controlled (+2 - +8 °C, +15 - +25 °C) and

freezer storage (-15 - -25 °C).• reliable and rapid delivery by high-quality temperature-

controlled containers. • monitoring of battery level and temperature degree on

container. • Correct temperature range with both heating and cooling

facility.• Dry ice support upon request.

Turkish Cargo Cares for your Temperature-Controlled Consignments of Pharmaceutical ProductsOur cool-chain specialists are ready to listen to you. you can contact us for any inquiries and problems about your pharma consignments. For more information, you can e-mail [email protected] or visit our website www.tkcargo.com.

mAnuFACturIng PrODuCts & equIPment’s

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Rapid Micro Biosystems


microbiologists of samples that are out of specifi cation.Environmental Monitoring- the growth Direct™ system isdesigned to handle the high volumes unique to environmentalmonitoring. With two incubators and a capacity of over 700 cassettes, the system can run a three-day environmentalmonitoring test in 1 ½ days, and over 450 samples per day.the technology supports the sampling of air, surface and personnel with data available for trend analysis.

Sterility Testing - the growth Direct™ system supports the closed loop environment necessary for sterility testing. the detection technology can uncover a positive within hours and fi nal results in about seven days. The test environment includes both aerobic and anaerobic testing. Because the test is non-destructive, any positive can be available at the end of the test for identifi cation, saving time.

Flexible Deployment. the growth Direct™ system is self-contained, housing two incubators, software, robotics and imaging. Once a sample is loaded, the growth Direct™ system manages the incubation, detection, enumeration and reporting.

Automated, Rapid Sterility, Environmental Monitoring and Bioburden Testingthe growth Direct™ system is designed to be a single test method for use with all the key tests in the microbial quality control lab. Sample preparation closely matches the existing tests, simplifying training of technicians. the technology can support all tests within one instrument, or each test within a separate unit.

Bioburden Testing - the growth Direct™ system has been validated for testing in water and bioburden. Preparation of the fi lterable sample mirrors the existing method, with results in about half the time. Action and alert limits notify

rapid micro Biosystems helps companies in the pharmaceutical, biotech, and personal care products industries automate and accelerate their microbial quality control testing, often a gating factor to product release. With offi ces in the US and Europe, rapid micro Biosystems has a singular focus on providing businesses a technology for automated rapid detection through the growth Direct™ system. the growth Direct™ system, by rapid micro Biosystems, automates the detection and enumeration of colonies in microbial quality control in manufacturing. the system includes two incubators, robotics and imaging systems that detect and enumerate microbial growth in about half the time of the traditional method. By using the natural autofl ouresence of living cells, the system “sees” colonies forming at about 100 cells, far sooner than the human eye. this allows the technology to provide results in about half the time of the traditional method.the technology takes the best features of the current traditional method, the mainstay of quality control microbiology for the last 100 years, and improves upon them. the growth Direct™ system is a growth-based method and reports results in CFus. the traditional method relies heavily on technicians to ensure proper incubation and reading of the samples. manual errors, such as forgetting to move plates from one incubator to another during a serial incubation, or miskeying a CFu count, can generate a costly investigation. the growth Direct™ system allows companies to prepare samples in a similar fashion to traditional methods and automates the incubation and detection. Once a prepared sample is loaded into the system, the technology ensures proper incubation, automatically moves cassettes between incubators if needed, and regularly performs an image analysis to look for any growth. In addition, the system reports results in CFu with updates to laboratory information systems (lIms). this automation minimises the human intervention that can cause detection errors.

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Because of this, the system could be deployed outside of the lab, closer to the manufacturing area, saving time in transportation.

Integration to LIMS. the technology is designed to seamlessly integrate with existing laboratory information systems, eliminating manual keying errors.

Positive results in hours. the growth Direct™ imaging technology regularly views and analyses cassettes for growth. this means that positive results can be available in hours, allowing the business to quickly react to an OOs event. Final results are available in about half the time of the traditional method.


Non-destructive. the growth Direct™ system is non-destructive and uses no reagents. Colonies are available at the end of the assay for investigation and identifi cation. Less complex validation. The Growth Direct™ technology is based on the compendial method, uses industry standard media, reports in CFus or positives in the case of sterility, and replicates the current sample preparation. this makes the method less complicated to validate than other technologies.

Full support services. rapid micro Biosystems not only provides the growth Direct™ system, but also supporting services to ensure successful validation and operation. these include:• On-site installation • Instrument services• Validation services - Iq, Oq, Pq and method validation,

including full documentation package and on-site support• regulatory compliance assistance• technical support throughout the Americas and europe• System certifi cation training.

rapid micro Biosystems serves pharmaceutical, biotech and personal care product companies in both north America and europe. manufacturers in these industries struggle to bring product to market faster and at a high level of quality. the ability to accelerate and automate the microbial quality control testing brings tangible benefi ts to these companies.

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No Substitute for Experience

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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 confi guration 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 fi nal 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 serviceWoodley 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 certifi ed 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 (IBms) and the Institute of Clinical research (ICr).

For more information on any of our products or services, please contact Vijay manchha on [email protected] or speak to one of our team on 08456 777001 or 1-800-471-9200.

the best value for money equipment solution from a large range of options.Our highly-qualifi ed technical team includesservice engineers,medical electronics technicians andbiomedical scientists who are also registered

Outsource the procurement of equipment for your next clinical trial to Woodley Equipment, with the confi dence 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 offi ce 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 thatWoodley has developed a unique range of services.From the initial enquiry stage to the fi nal conclusion of a clinical trial, a dedicated account manager will work closely with a customer to understand their specifi c 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

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COMPANY AT A GLANCE

SERVICES OFFERED

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WOODLEY EQUIPMENT COMPANY

UK Office USA Office

www.woodleyequipment.com

Supplying the Clinical Trials Industry for over 25 years:

Full Servicing, Calibration and Technical Support

Total Asset Management and Tracking

Complete Global Logistics

A Fully Tailored Service

Global Equipment SolutionsRental / Purchase

COMPANY KEY FEATURES

Almac Group• Biomarker Discovery & Development• API Manufacture• Formulation Development• Clinical Trial Supply & IVR/IWR Technology• Commercial-scale Manufacture

AmSafe• Heavy duty and lightweight re-usable, thermal, protection blankets• Single/ limited use, easy to handle thermal cover solutions• Manufacturing operations and service facilities around the globe• Technical and performance data to assist validation• Support, guidance and advice with customer trials

Bachem AG• Peptide and Small Molecule APIs• Process development and scale-up• Batch sizes from mg to kg and tons• cGMP and non-GMP production• Regulatory documentation support

Chesapeake Limited• Pharmaceutical packaging• Artwork management• Patient information leaflets• Pharmaceutical cartons• Pharmaceutical labels

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

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

GEO® Specialty Chemicals• GEO glycine is produced in US (Deer Park, TX) only• High Purity grade (833-03) available and currently • used in a variety of pharmaceutical applications in• US, Asia, and EU• ISO 9001:2008 Certified• FDA Regulated• European Pharmacopee ( EP) Certified

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

MPI Research • Drug Safety/Preclinical Solutions• Discovery Sciences• Bioanalytical and Analytical Solutions• Surgical Services and Medical Device Evaluation

Novozymes Biopharma UK Ltd.• Innovative products and technology• Hyasis® – sodium hyaluronate•Recombumin®–recombinanthumanalbumin•EnzymesforBiocatalysis•Technicalsupportandregulatorypackage

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• Healthcare Packaging Solutions• Pharmaceutical Commercial Packaging Solutions• Clinical Trial Packaging Services• Developmental Analytical Laboratory Services• Blistering, Bottling, and Cold Chain Capabilities

Pöppelmann GmbH & Co. KG• Packaging• Dispensing, Dosing, Pouring• Pharmaceutical packaging• Medical Technology• Laboratory and diagnostics

Presspart Manufacturing Ltd. • MDI components• MDI actuators • MDI canisters • Dispensing Actuators • Medical Devices

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

THERAPURE BIOPHARMA INC. • Cell Line Development• Upstream & Downstream Process Development• Analytical Methods Development• cGMP Biomanufacturing – Upstream Processing and Downstream

Purification• Aseptic Fill / Finish – Vials, Prefilled Syringes and Lyophilization

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 Ltd • Rental / Purchase• Global Solutions• Medical/Lab Equipment• Complete Logistics• Technical Support

For Highest Demands.

Pöppelmann GmbH & Co. KG · Kunststoffwerk-Werkzeugbau · Pöppelmannstraße 5 · 49393 Lohne · Germany Phone +49 4442 982-3900 · Fax +49 4442 982-417 · [email protected] · www.poeppelmann.com

We develop and produce sophisticated plastic functional parts and packaging for the medical and the pharmaceutical industry. Our economical standard products are tailored to the needs of small and medium-sized businesses. They help you to reduce time to market and ensure that your product is presented appealingly. Use our tailor-made solutions if our standard program does not have a solution for your application.

Cleanroom production in accordance with DIN EN ISO 14644-1 – Class 7 and Class C of the EU-GMP guide. Quality management system certified in accordance with DIN EN ISO 9001:2008 and DIN EN ISO 13485:2010.

Ipi outsourcing supplement 2013

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Transcript of Ipi outsourcing supplement 2013