GMP Manufacturing

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 1,100 released batches 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, polysaccharides (including activations and conjugations capabilities) as well as Live Microbial Products.

GMP Facilities

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. Corresponding primary recovery, downstream and Fill & Finish capabilities are available to suit various customer needs along the development path.

GMP Facilities

  • 270 l stainless steel fermenter with associated downstream processing stream
  • 250 l single use bioreactor with associated downstream processing stream
  • 1,500 l stainless steel fermenter with several separate downstream processing suites
  • BSL 1 and 2

Experience Proteins

  • Antibody fragments
  • Single domain antibodies
  • Scaffolds
  • Fusion proteins
  • Enzymes including proteases
  • Interferons
  • Cytokines
  • Growth factors
  • Hormones
  • Peptides
  • PEGylated/PASylated proteins and peptides
  • Multi-domain proteins
  • Disulfide-rich proteins
  • Cysteine-knot motives

Experience Vaccines

  • Polysaccharide vaccines
  • Live attenuated vaccines
  • Conjugated vaccines
  • Recombinant protein vaccines

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 and drug product production (including lyophilization) in our facilities in Amsterdam.

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 with associated downstream processing stream
  • 1,500 l stainless steel fermenter with several separate downstream processing suites
  • BSL 1 and 2

Experience Live Microbial Products

  • Vibrio cholera
  • Salmonella typhi
  • Lactococcus lactis
  • Lactobacillus acidophilus
  • Lactobacillus reuteri
  • Bifidobacterium lactis
  • Bifidobacterium longum
  • Oxalobacter formigenes
  • Saccharomyces cerevisiae
  • Listeria monocytogenes

Wacker Biotech GmbH

Hans-Knöll-Strasse 3
7745 Jena
Germany
+49 3641 5348-0

Contact Location