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Vetter Pharma International

High-Quality Aseptically Pre-Filled Injection Systems, Cartridges and Vials

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Vetter Pharma International

From preclinical development through commercial supply.

For more than 25 years, the Vetter name has stood for quality, innovation and strategic partnership.

An independent, leading provider of aseptically prefilled syringes, cartridges and vials, Vetter supports pharmaceutical and biotech clients throughout a product’s lifecycle, from preclinical development through regulatory approval and market supply worldwide.

Vetter is headquartered in Ravensburg, Germany.

Monoclonal antibodies, peptides, interferons and vaccines

Biotechnology drugs, in particular, are highly sensitive complex compounds that are very expensive to produce.

Vetter has extensive experience working with biotech substances, including monoclonal antibodies, peptides, interferons and vaccines. Types of stopper, types of glass, and degree of siliconisation can all potentially interact with a product’s active ingredient.

Knowing how to match drug product to delivery system is critical, along with designing an appropriate manufacturing process. So is maximising active pharmaceutical ingredient (API) yield. Vetter’s state-of-the-art technology preserves APIs during the filling process, and Vetter’s experience in the industry minimises wasteful trial and error.

Aseptic prefilled drug-delivery systems

Vetter is an acknowledged leader in aseptic filling. Its key features include:

•  Vetter works with the world´s leading pharmaceutical and biotech companies

•  Vetter is a leader in the use of restricted access barrier system (RABS)2 technology in cleanrooms

•  Vetter invented dual-chamber technology, including the Vetter Lyo-Ject® dual-chamber syringe3 and V-LK® cartridge

•  Vetter holds numerous patents on drug-delivery system processes and components

•  Vetter is an expert in lyophilisation (freeze-drying), often required to prolong product shelf-life

Dual-chamber technology and anti-counterfeiting measures

Vetter’s services include:

•  Vetter Development Service: product management from preclinical development to market launch

•  Vetter Commercial Manufacturing: large-scale production and packaging of aseptic prefilled drug-delivery systems

•  Vetter Solutions: proprietary innovations, from dual-chamber technology to anti-counterfeiting measures

Regulatory expertise for pharmaceutical product approvals

Vetter supports clients on effective strategies for achieving multinational product approvals.

Approved as a foreign manufacturer by the Government of Japan, Vetter offers broad global regulatory experience, including support for numerous customer product approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Vetter has also worked with regulatory authorities in Canada, Russia, Brazil, Mexico, Saudi Arabia, Algeria, South Korea, Taiwan and Iran, among others.

Supporting a faster time-to-market

Vetter’s services include:

•  Project management: Across functions and facilities, throughout the development effort, Vetter teams communicate and coordinate using project management principles. This process-driven approach helps keep projects on track and timelines tight.

•  Technology transfer: Development and commercial teams closely coordinate a product’s transfer from Vetter’s development labs to its large-scale manufacturing facilities. Vetter replicates commercial-stage processes in its early-stage laboratories to help prevent surprises at market production.

•  Partnership: Client collaboration is one of Vetter’s distinguishing hallmarks. A close working relationship not only opens communication and instills trust, it helps prevent wrong turns and rework – which, in turn, helps save time and costs.

Aseptic filling operations and a secondary packaging facility

Vetter’s commercial manufacturing facilities include three aseptic filling operations and a state-of-the-art secondary packaging facility, which together represent a total capacity of up to 400 million production units per year.

Vetter production facilities work independently of each other and, to a large extent, have identical production processes, which enables them to serve as backup reserves, offering customers an extremely high degree of delivery and process security.

Vetter’s new Chicago facility supports small-batch preclinical through phase II products. At phase III, products will be transferred to Vetter’s commercial manufacturing facilities. Since two-thirds of early-stage development projects are located in North America, the Chicago site – an expansion of Vetter Development Service, represents Vetter’s strategic approach to serving the needs of its clients.

Contact

Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg
Germany

Tel: +49-(0)751-3700-3729
Fax: +49-(0)751-3700-7707
press@vetter-pharma.com
www.vetter-pharma.com

2RABS = restricted access barrier system, an innovation in contamination control
3Freeze-dried drug resides in one chamber; liquid in the other. Pushing the plunger mixes the two, reconstituting the drug. This prolongs shelf-life, promotes accurate dosing, and enables patients to self-administer.

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Vetter Solutions

Vetter Solutions develops proprietary, patented innovations. The Vetter Lyo-Ject® dual-chamber syringe was designed especially for pharmaceuticals preserved by freeze-drying.

One chamber contains the lyophilised drug; the other, the solution. The drug is reconstituted immediately before application. This all-in-one concept enables longer storage periods and a more user-friendly product, as well as more accurate dosing. Vetter's V-LK® dual-chamber cartridge enables multiple dosages of lyophilised drug, and is used in pen and auto-injection systems. The V-OVS®…

Vetter Development Service

It is essential that a substance and its delivery system are optimally compatible. Biotechnology drugs, in particular, contain highly sensitive active ingredients that can interact with the drug-delivery system. Other considerations include a drug's sensitivity to oxygen or to the silicone that coats the inside of a syringe to lubricate the plunger.

Vetter Development Service specialises in taking complex compounds from preclinical development through market launch. In close collaboration with its customers, Vetter selects: The drug-delivery system that matches the requirements of the drug in development Appropriate processes, such as lyophilisation (freeze-drying) for unstable products Suitable transport magazines and secondary packaging components Special inspection devices and methods…

Vetter Commercial Manufacturing

Vetter Commercial Manufacturing serves a global customer base, including the world's leading pharmaceutical and biotech companies. The company fills products in accordance with international standards and handles the full scope of production, from aseptic filling to final packaging.

Vetter's manufacturing facilities are highly automated and use innovative technologies. Vetter is a leader in restricted access barrier systems (RABS) technology, used in state-of-the-art cleanrooms to minimise risk of contamination. RABS combines the functionality and stability of an insulator with the flexibility of a classical cleanroom. Laminar airflows establish barriers between staff and machinery. All…
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Vetter introduces South Korea’s pharma and biotech community to meet company management

In an event at its new branch office attended by key customers and business associates, Vetter’s senior management representatives presented...
2nd February 2018

Vetter lays the foundation for a state-of-the-art administration building

At a cornerstone ceremony, Vetter officially signaled the start of a project for the creation of a new administration building...
28th September 2017

Vetter and Microdermics Enter into a Strategic Cooperation Agreement to Develop Innovative Microneedle Drug Delivery Systems

Vetter, a leading and innovative provider of aseptic prefilled drug delivery systems and Microdermics Inc., a Vancouver-based medical device company...
12th July 2017

Vetter and Microdermics Enter into a Strategic Cooperation Agreement

Vetter and Microdermics Enter into a Strategic Cooperation Agreement to Develop Innovative Microneedle Drug Delivery Systems.
1st June 2017

Vetter’s Dr. Claudia Roth is appointed to the Fraunhofer Advisory Board

Appointment will allow for active involvement within the Fraunhofer Institute for Manufacturing Engineering and Automation IPA
1st June 2017

New Vetter Data Processing Center is Officially Certified

IT experts of TÜV Süd, a German industrial testing organization, have certified the new data processing center at Vetter's headquarters...
3rd March 2017

Vetter’s Skokie Site Successfully Manufactures Batches on New Clinical Syringe Filling Line

Vetter, a leading international contract development and manufacturing organization (CDMO) that specializes in aseptic filling for its (bio-)pharmaceutical customers, has...
3rd March 2017

Vetter Starts Operations in its Center for Visual Inspection and Logistics

Vetter, a leading global Contract Development and Manufacturing Organization (CDMO) for development, aseptic filling and final packaging of injectables, has...
3rd March 2017

Vetter announces Oliver Albrecht has been appointed Managing Director

Vetter, a leading contract development and manufacturing organization that specializes in aseptic manufacturing, today announced that the company’s Advisory Board...
13th April 2015

State-Of-The-Art Chicago Facility is Fully Operational

Vetter’s 24,000-square-foot site includes microbiology and chemical analysis labs, material preparation and compounding functions, as well as three cleanrooms for...
26th March 2012

Vetter Internationally Recognized For Environmental, Health and Safety Program

Vetter received certification for its integrated management system for environmental, health and safety (EHS). The company earned ISO 14001 certification...
26th March 2012

Vetter Packages Success with New Facility

Vetter's new secondary packaging operation allows the company to double its production in half the time.
21st January 2010

Pharma Supplier Vetter Shares Pride in Consistent Growth and International Success with Distinguished Visitor Minister zu Guttenberg

Economics and Technology Minister visits global leader's headquarters in southern Germany.
21st January 2010

Vetter Dedicates New Facility in Suburban Chicago

The new facility will enable collaboration very early in development process
21st January 2010
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