Vetter Pharma International - Filling your clinical development needs

Vetter Development Service supports your drug-development projects, from inception to market launch. Our facility in Chicago, US, along with our existing sites, provides clinical manufacturing from preclinical development through Phase II, with scale-up and transfer to our commercial manufacturing facilities. The Chicago site is specifically designed to support the development of your early-stage, high-value biopharmaceuticals. Vetter Development Service fills clinical trial materials under strict aseptic and GMP standards. Thanks to state-of-the-art technology and innovative processes, we help increase your active pharmaceutical ingredient (API) yield.

Vetter Development Service provides you with:

Formulation support

In 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 APIs for clinical trial - as well as identify the strongest of several prequalified candidate drug formulations through compounding and filtration studies, API/material compatibility analysis and lyophilisation cycle testing. Transfer, optimisation of analytical methods and validation is also provided.

Process development

The goal of process development is to enable the fast, smooth transfer of your project to commercial manufacturing. Tailored to your product's specific requirements, process development services include:

  • siliconisation methods studies for the appropriate drug delivery system
  • filter compatibility testing
  • lyophilisation cycle development if required
  • feasibility studies
  • engineering batches, stability and validation batches
  • method transfer and scale-up for commercial manufacturing.

Clinical trial manufacturing

Following confirmation of successful process scale-up, clinical production begins. Key steps include compounding, filtration, preparation of primary packaging materials and filling. Additional steps may include lyophilisation, terminal sterilisation and visual inspection. Precise indicators are also generated for the master batch record.

Analytical service

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

Regulatory support

Vetter 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).

Company at a glance

Vetter is a leading independent contract development and manufacturing organisation (CDMO) that specialises in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds 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 Packaging Solutions matches drug substances with the appropriate drug delivery system for a product's life cycle.
  • Vetter Commercial Manufacturing provides Phase lll manufacturing through global market supply.

Products and Services

Contact Details

Vetter Pharma International
Eywiesenstrasse 5
88212 Ravensburg
Germany
Contact: Newsletter subscription
Tel: +49-751-3700-0
Fax: +49-751-3700-4000
Email: info@vetter-pharma.com
URL: http://www.vetter-pharma.com/ja/newsletter_en/subscription-vetter-news
URL: www.vetter-pharma.com

Semi-automated filler at Vetter's Chicago facility: vial fitting.
Fully automated vial filler at Vetter's Chicago facility: lyophilised vials are prepared for capping.
Lyophilisation of vials.
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