GMP Production - Wacker Chemie AG


GMP Production

GMP Manufacturing Proteins & Vaccines

With over 20 years of experience producing microbial derived proteins and vaccines, Wacker Biotech is a world-leading partner when it comes to manufacturing microbial biopharmaceuticals for our customers. Five production lines in Jena, Halle (Germany) and Amsterdam (The Netherlands) are equipped with stainless steel fermentation vessels from 270 to 1,500 liter as well as single-use bioreactors and WAVE bags. Corresponding primary recovery, downstream and Fill & Finish capabilities are available to suit various customer needs along the development path (BSL 1 and 2).

Wacker Biotech`s multi-purpose GMP facilities in Jena, Halle (Germany) and Amsterdam (The Netherlands) offer manufacturing capabilities for microbial-based biopharmaceuticals for worldwide supply according to the highest quality standards. Our clients also benefit from our ‘one stop shop’ service offering (GMP cell banking, development, bulk drug substance and drug product production), providing program flexibility, reduction in time and a reduction of costs.

With more than 200 successfully accomplished projects for our customers across the globe, Wacker Biotech has expertise in production of soluble and insoluble recombinant proteins (including inclusion bodies and re-folding capabilities), wild-type microbial antigens, microbial vaccines and polysaccharides (including activations and conjugations capabilities).

GMP Facilities:

  • Stainless Steel: 270 l, 350 l, 2 x 1,500 l
  • 250 l SUB (single use bioreactor)
  • BSL 1 and 2

GMP Manufacturing Live Microbial Products

Wacker Biotech is leader in the manufacture of live microbial products, which are products containing whole, live microorganisms, such as bacteria or yeast with an intended therapeutic or preventive effect in humans (distributed oral, topical, intravenous etc.).

Wacker Biotech has over 10 years of specialist experience in working with live microbial products, which, involves, inter alia, the development of scalable and fully closed monoseptic production processes (full aseptic handling from fermentation to filling of the product capable of parenteral administration). As a world leader in this field, we can offer both bulk drug substance (BDS) and drug product (DP) production (including lyophilization) in our facilities in Amsterdam.

GMP Manufacturing

Wacker Biotech has experience in working with many different types of live microbial products, helping its customers to create a robust and controlled process, allowing them to expedite products through the various clinical phases to commercial launch.

The GMP microbial facilities for the production of clinical phase and marketed live microbial products at Wacker Biotech include:

  • 270 l stainless steel fermenter with associated downstream processing stream
  • 250 l single use bioreactor (SUB) with associated downstream processing stream
  • 1,500 l stainless steel fermenter with several separate downstream processing suites
  • Several WAVE bioreactors (20 l to 200 l) for use in the production of a range of products, all with associated downstream processing stream

Jena

  • Jena, First Floor
  • Jena, Second Floor
  • Jena: primary recovery compartment 300 l – 2800 l stainless steel vessels
  • Jena: fermentation compartment bioreactor 300 l
  • Jena: taking a fermentation sample
  • Jena: chromatography compartment
  • Jena: primary recovery compartment 300 l – 2800 l stainless steal vessels
  • Jena: primary recovery compartment 300 l – 2800 l stainless steel vessels
  • Jena: chromatography compartment
  • Jena: primary recovery compartment 300 l – 2800 l stainless steel vessels

Halle

  • Floor Plan Halle
  • Halle: fermentation compartment bioreactor 1500 l
  • Halle: fermentation compartment bioreactor 1500 l
  • Halle: refolding tank 2700 l
  • Halle: fermentation compartment bioreactor 1500 l

LOCATION SELECTION

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Contact

Wacker Biotech GmbH
Jena and Halle (Germany)
Tel. +49 3641 5348-150

Wacker Biotech B.V.
Amsterdam (the Netherlands)
Tel. +31 20 750 3600