A unique blend of expertise - Vetter Pharma · 2018-10-19 · Vetter Development Service I Vetter...

Vetter Development Service I Vetter Commercial Manufacturing I Vetter Packaging Solutions Vetter Development Service I Vetter Commercial Manufacturing I Vetter Packaging Solutions

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SIZE: 42 cm x 29.7 cm

@ crops with ..3175 cm

bleed; FOLDED SIZE: 21 cm x 29.7 cm

205 N. Michigan Ave.–Suite 2315

Chicago, Illinois 60601-5923 Tel: 312.645.0100 Fax: 312.645.0120 ALL LIVE G

RAPHICS INCLUDED IN LINKS FOLDER.

FONTS: Helvetica LT Std, Univers LT Std, Zaph Dingbats

A unique blend of expertise

From clinical development to commercial production

Answers that work

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There are many sides to your product’s success.

Build them together at Vetter.

Whether your injectable is still at the starting line or in full-scale production, there are possibilities all around you. Thoughtful questions that can open new doors. Precisely planned processes that can shorten lead times. Innovative solutions that can transform complex challenges.

At Vetter, we look at your project from every angle to help you find answers that work – answers that support your goals for quality, reliability, innovation, safety, and efficiency.

Succeeding in today’s global pharmaceutical and biotech markets takes both flexible thinking and precise manufacturing. We invite you to learn how Vetter can help you get the right results on all sides.

Vetter Development Service I Vetter Commercial Manufacturing I Vetter Packaging Solutions 3

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There are many sides to your product’s success.

We are a global leader in aseptic contract filling. Our foundation of experience spans more than 35 years and dozens of successful pharmaceutical and biotech compounds. We offer specialized resources from development and clinical supply to commercial fill and finish, final packaging, and life cycle management.

As a family-owned, independent company, we do not manufacture our own drugs. Our focus is solely on our customers’ success.

Who is Vetter?

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Experience-based

solutions

High-quality manufacturing

Precise project

management

Future growth planning

Fully integrated resources

We are proud of our partnerships and continually invest in high-quality, specialized resources and technologies that help our customers develop and supply their products with confidence.

Be confident. Your product is on target.

Why choose Vetter as your clinical development and manufacturing partner? The answer is simple: a unique blend of expertise that helps launch and grow successful products.

Keeping our customers on the leading edge

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Be confident. Your product is on target.

A partnership for every stage of growth.

–Formulation support –Process development –Clinical trial manufacturing –Analytical services –Regulatory support

–Fill and finish–Analytical services–Regulatory support –Product life cycle management

–Customized packaging development–Specialized technologies –Proven platform technologies –Packaging services–Logistic services

Preclinic I IND I Phase I and II I Phase III NDA I Approval I Launch

Integrated through all stages of development and manufacturing

Vetter Development Service I Vetter Commercial Manufacturing I Vetter Packaging Solutions

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Vetter Development Service offers 2 state-of-the-art clinical production locations strategically located in Ravensburg, Germany and Chicago, US. Each facility provides a wealth of expertise and manufacturing resources to support the successful development of new compounds, including peptides, monoclonal antibodies, suspensions and diluents, and vaccines (non-live).

How can we grow your success?

Vetter Development Service helps streamline your product’s path to clinic.

Every new compound has high expectations – and highly specialized requirements that are pivotal to a successful clinical trial. Vetter Development Service brings together a unique blend of people, processes, and technology to guide your molecule from preclinical development through market launch.

Resources where you need them

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The smallest decisions can have long-term consequences. From the first planning meetings, quality is first and foremost, and strict quality assurance protocols guide all process design, testing, and validation steps.

Quality for the long run

The right solutions. The right results.

Vetter brings you decades of experience solving complex development challenges.

Vetter Development Service is divided into specialized departments that work together to accomplish critical goals, such as optimizing efficiency and expediting time-to-market.

The foundation of your project is a well-defined project plan, which guides the development of key implementation details such as material compatibility, pump, and filtration studies. It also reflects long-range needs, allowing solutions for future growth to be built into your product’s design from the ground up.


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People Process Technology

Inside Vetter Development Service

Advanced expertise in

– feasibility studies

– compounding, pump and filtration design

– chemical and microbiology analysis

–lyophilization

–siliconization

–regulatory compliance

– packaging material development

Integrated steps encompass

– peer-to-peer project management

– implementation of process design

– method transfer

– full regulatory support for streamlined approval

– seamless transfer to commercial manufacturing

Preclinical and Phase I– Phase III manufacturing includes

– non-cGMP/cGMP automated filling

– liquids and lyophilized products in vials, syringes, and cartridges

–clinical supply

– extensive primary and secondary packaging capabilities

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Vetter Commercial Manufacturing offers state-of-the-art fill and finish services for a wide range of injectable compounds, including analytical testing, life cycle management, and regulatory support.

How can we fill your needs?

From patient safety to security of supply, every detail counts.

Vetter Commercial Manufacturingdelivers seamless expertise across the production chain.

Choosing a manufacturing partner for your injectable is a major strategic decision. With years of experience mastering complex manufacturing challenges, Vetter knows the smallest details can impact your success.

This is why we continually invest in processes, training, and technologies that support consistent, high-quality results, including

n state-of-the-art equipment and facilities designed to deliver products with efficient precision

n integrated software to monitor quality and track regulatory data across all production sites

n a process optimization program staffed by Six Sigma team members certified as black, green, and yellow belts

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Vetter takes active steps both downstream and upstream to maintain the integrity of the supply chain, including regular quality reviews of all suppliers, cross-linked IT systems to monitor manufacturing processes, and new, advanced cold chain logistics and storage resources.

Locking in security of supply

Creative thinking. End-to-end quality.

It takes both to manufacture injectablesthat set a higher standard.

Sterile injectable manufacturing is just the beginning of Vetter’s expertise. Finding new ways to deliver added value – with better yields, shorter lead times, and innovative solutions to difficult or costly problems – is fundamental to our partnership with you. So is meeting the highest possible safety and quality standards.

n Our production sites include 3 independent commercial facilities, each with its own analytical testing and 100% visual inspection process

n Industry-leading Restricted Access Barrier Systems (RABS) and Vetter CleanRoom Technology (V-CRT®) ensure exceptional sterility in filling and finishing

n High-quality results are maintained by tightly integrated Quality Assurance and Quality Control programs as well as ongoing quality improvement initiatives


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Exceptional expertise through all stages of production, including

– analytical service

– engineering and pharmaceutical production

– dedicated customer service

– Quality Control/Quality Assurance

Finely tuned systems and procedures designed to

– enhance transparency and production monitoring

– optimize yields and reduce batch cycle times

– provide precise supply chain management

– streamline regulatory approvals

– guide innovative life cycle management

Ongoing investment in state-of-the-art resources that support

– redundant power supply at each site

– both high-value dedicated equipment and disposable equipment

– a broad menu of drug delivery systems and packaging solutions

– integrated TrackWise® system for quality management

People Process Technology

Inside Vetter Commercial Manufacturing

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From materials to safety devices, all aspects of packaging are now under tighter regulatory scrutiny to ensure patient safety. At Vetter, the safety and integrity of our packaging solutions are carefully planned right from the start. Our manufacturing facilities meet strict hygiene and environmental controls, and comply with cGMP guidelines for the US, Europe, and Japan.

Safety first

Ready to reshape your product’s potential?

Vetter Packaging Solutionsbuild in safety, quality, and opportunity.

In today’s parenterals market, packaging matters. Specialized delivery technologies that promote a compound’s integrity, growing demand for user-friendly pens and autoinjectors, advanced materials for silicone-sensitive APIs – so many factors can play a role in your choice of primary and secondary packaging design and materials.

Which options are key to your product’s performance and long-term potential? Learn how Vetter’s packaging experts can help you identify and develop the right solutions at key product life cycle stages.

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One product. Many options.

Find the best ways to fill your product with Vetter.

Throughout your product’s life cycle, Vetter works closely with you to develop packaging solutions that optimize your strategic goals.

Customized packaging development As specialists in the production of many kinds of compounds, Vetter can

n help you select the ideal injection system and materials for your compound’s specific characteristics

n provide in-depth advice on important considerations in primary and secondary packaging

n develop custom packaging solutions to help optimize end user convenience and production efficiencies

Specialized technologiesVetter’s specialized packaging systems help you deliver your injectable with exceptional innovation and convenience.

n Vetter-Ject®, a tamper-evident closure system for prefilled syringes, allows baked-in siliconization of an integrated needle syringe, offering many advantages for highly-sensitive compounds such as biologics

n Vetter Lyo-Ject® dual-chamber syringes for lyophilized compounds increase storage time, add patient convenience, and differentiate your product in the market

n V-LK® dual-chamber cartridges enable multiple dosages of lyophilized drug in pens

n V-OVS® tamper-evident closure systems promote your product’s safety and integrity

n Versatile technologies for specialized manufacturing or compound needs also include

– bulk glass syringes

– polymer syringes

– safety devices

– cartridges for pens and pump systems

– syringes for autoinjectors


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FONTS: Helvetica LT Std, Univers LT Std, Zaph DingbatsProven platform technologies When conventional delivery systems are best suited to your product needs, Vetter offers high-quality aseptic filling of both vials and presterilized/nested glass syringes (with staked needle or luer lock cap options).

Sterile, prefilled water for injection (sWFI) syringes for reconstituting lyophilized compounds add additional flexibility. Designed with all-in-one convenience, sWFI syringes are simpler and safer for patients to use, and include proven stability data to streamline registration and accelerate your path to market. Ready-to-submit documentation is available for Europe, Japan, and the US.

Find the best ways to fill your product with Vetter.

Packaging servicesVetter’s integrated state-of-the-art packaging services support your product with carefully designed, efficient solutions. Choose from a comprehensive menu of services, including

n packaging services for smaller batch sizes, from assembly through storage

n full market supply services for commercial production

– assembly

– printing

– labeling

– blister packing

– cartoning – storage

– serialization – cold chain logistics

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Knowledge that goesabove and beyond.

Vetter Answers: How specialized expertise gives you an inside edge.

Vetter is more than just a single-source partner for contract manufacturing. We’re a company of integrated specialists who collaborate on your project’s success from initial planning through full market supply and beyond.

Our answer-focused approach is built on decades of hands-on problem solving and innovation in key areas including

n siliconization

n lyophilization

n analytical methods transfer

Vetter works with you through all phases of regulatory submission. We have an excellent track record with global regulatory agencies, including FDA, EMA, PMDA (Japan), and RP (Germany). Vetter undergoes about 10-15 inspections by different international regulatory authorities and 30-40 customer audits each year. We have successfully completed approx. 50 FDA client products (drug products and diluents) approvals.

Global regulatory expertise

n process optimization

n strategic life cycle planning

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Peptides

Monoclonalantibodies

Vaccines(non-live)

Peptides

DiluentsSuspensions

Everyday challenges. Exceptional solutions.

Bring us your challenges. Vetter finds answers.

Imagine a sensitive biologic product with tremendous potential suddenly sidelined during development by excessive reactivity to silicone oil. It’s a roadblock that can be difficult to predict in early planning, yet can significantly impact time-to-market.

At Vetter, anticipating complex technical challenges is a critical early step in the project planning process. Scientists and manufacturing specialists then focus on developing novel, efficient solutions tailored to your product’s specific needs.

Your team will include experts with in-depth experience in many technical disciplines and classes of products.


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Lyophilization A significant number of injectable drugs now require lyophilization to protect biological activity, increase dosing precision, and extend shelf life.

Vetter offers decades of expertise and innovation in lyophilization. Recognized industry specialists work closely with your team to design a lyophilization cycle that optimizes efficiency and yields. They also conduct comprehensive feasibility analyses to help ensure your active substance is perfectly matched to its method of administration.

Method transferVetter’s analytical team is regularly involved in highly customized, intensive work to guide the critical transfer of microbiologic and chemical analytical methods.

Their experience and skill streamline the many complex issues involved in a successful transfer, including starting material testing, new method validation, instrument validation, process qualification, stability testing, and clinical testing.

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Purpose. Process. Performance.

A collaborative partnership with Vetterkeeps you at the center of success.

What makes Vetter a different kind of contract manufacturing organization? It starts with vision. We see you as equal partners in a collaborative process built on trust and clear communication.

Just as importantly, everything we do is centered around quality. We take pride in our ability to generate innovative ideas, and to implement them systematically and cost effectively.

Vetter is recognized for excellence in operational performance and end-to-end supply chain management by Oliver Wight International.

Class A operational performance

Strategic approachOur strategic approach can be defined in a single word: alignment. All decisions, both within the company and with our customers, are aligned to clear, specific goals. From corporate planning and forecasting to creative, proactive life cycle strategies for our customers, we believe the best results come from never losing focus on the results you want to achieve.

Management Employees Facilities ProcessesCustomer


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Vetter’s long-standing commitment to safety and sustainable development is reflected in a wide range of initiatives, including healthy working conditions, energy-saving production methods, and innovative waste-recycling strategies. Our efforts have been acknowledged by 3 international certifications:–ISO 14001 certification for the Vetter environmental, health, and safety (EHS) system – BS OHSAS 18001 certification for the Vetter occupational health and safety management system

–ISO 50001 certification for the Vetter energy management system

Protecting our employees and the environment

Project management and product planningAt the heart of every successful project is a clear dialogue between partners and an intelligent, disciplined project management process.

n Structured peer-to-peer communication streamlines information flow between customers and key staff members

n Dedicated project managers follow projects from conception through final delivery, providing continuity at all stages

n Transparency in all aspects of project workflow supports efficient time-to-market

n Early, proactive life cycle management strategies strengthen market success

Quality systems and key performance indicatorsVetter’s quality and performance measures set a high bar for your product’s success. Quality management consists of multiple elements, including

n ongoing quality reviews and trending initiatives

n analysis of all process steps to determine potential production changes that can improve yields, reduce batch cycle times, and reduce errors

n close monitoring of Key Performance Indicators, such as Right-First-Time (RFT) batch quality and On-Time-in-Full (OTIF) supply performance

Vetter is recognized for excellence in operational performance and end-to-end supply chain management by Oliver Wight International.

Answers that workwww.vetter-pharma.com

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For further information, please get in touch with us

Vetter Pharma International GmbH Eywiesenstrasse 5 88212 Ravensburg Germany

phone: +49-(0)751-3700-0 fax: +49-(0)751-3700-4000 e-mail: [email protected]

Vetter Pharma International GmbH Singapore Branch The Metropolis, Tower 2 Level 8 Unit-09, North Buona Vista Drive Singapore 138589

phone: +65-6808-7766 e-mail: [email protected]

Vetter Pharma International GmbH South Korea Branch#1106 Get-Pearl Tower, 12 Gaetbeol-roYeonsu-gu, IncheonKorea 21999

phone: +82-32-831-7039e-mail: [email protected]

Vetter Pharma International USA Inc. 10 W. Algonquin RoadDes Plaines, IL 60016 USA

phone: +1-847-581-6888 fax: +1-847-581-6880 e-mail: [email protected]

Vetter Pharma International Japan K.K. Level 28 Shinagawa Intercity Tower A 2-15-1 Konan Minato-Ku Tokyo 108-6028 Japan

phone: +81-3-6717-2740 e-mail: [email protected]

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A unique blend of expertise - Vetter Pharma · 2018-10-19 · Vetter Development Service I Vetter...

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