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GMP Manufacturing

Wacker Biotech’s multi-purpose GMP facilities in Jena and Halle (Germany), Amsterdam (the Netherlands) and San Diego (USA) offer manufacturing capabilities for microbial-based biopharmaceuticals for worldwide distribution that meet the highest quality standards. Our clients also benefit from our ‘one-stop-shopping’ service offering GMP cell banking, development, production and filling (fill & finish) for drug substances and drug products, as well as providing program flexibility, reduction in time and a reduction of costs.

With more than 1,200 released batches for our customers across the globe, Wacker Biotech has extensive expertise in the production of recombinant proteins (soluble and refolding), microbial vaccines, polysaccharides (including activation and conjugation), and plasmid DNA.

Take a Virtual 360° Tour of Our Facilities in Jena and Halle

Click on the links below and use your cursor to explore. With the drop-down menu at the top left of the screen you can switch between the Jena and Halle sites.

Enjoy a 360° panoramic tour of our state-of-the-art EMA/FDA-certified GMP facilities – right from your desk.

GMP Facilities

Five production lines in Jena, Halle (Germany) and Amsterdam (the Netherlands) are equipped with single-use bioreactors, as well as with stainless steel fermentation vessels ranging in volume from 270 to 1,500 liters. 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
  • 250 L single-use bioreactor with associated downstream processing
  • 1,500 L stainless steel fermenter with several separate downstream processing suites
  • BSL 1 and 2

Experience with 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 motifs

Five production lines in Jena, Halle (Germany) and Amsterdam (the Netherlands) are equipped with single-use bioreactors, as well as with stainless steel fermentation vessels ranging in volume from 270 to 1,500 liters. 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
  • 250 L single-use bioreactor with associated downstream processing
  • 1,500 L stainless steel fermenter with several separate downstream processing suites
  • BSL 1 and 2

Experience with Vaccines

  • Polysaccharide vaccines
  • Live attenuated vaccines
  • Conjugate vaccines
  • Recombinant protein vaccines

Experience with Vaccine Strains (Examples)

  • Escherichia coli
  • Corynebacterium diphtheriae
  • Haemophilus influenza B
  • Klebsiella oxytoca
  • Neisseria meningitidis A, C
  • Pseudomonas aeruginosa
  • Salmonella typhi
  • Saccharomyces cerevisiae
  • Vibrio cholerae

Wacker Biotech has over 10 years of specialist experience in working with live microbial products, which also includes 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
  • 250 L single-use bioreactor with associated downstream processing
  • 1,500 L stainless steel fermenter with several separate downstream processing suites
  • BSL 1 and 2

Experience with Live Microbial Products

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

pDNA can be used either directly for nucleic acid-based gene therapies and for vaccines or as a starting point for innovative therapeutic agents including messenger RNA (mRNA) and viral vectors.

The production site in San Diego is equipped with 30 L single-use bioreactors and 500 L stainless steel fermentation vessels. Corresponding primary recovery and downstream capabilities are available to suit various customer needs along the manufacturing path.

GMP Facilities

  • 30 L single-use bioreactors with associated downstream processing stream
  • 500 L stainless steel fermenter with associated downstream process stream

Experience with pDNA

  • Manufacturing of pDNA-based VM202 products for gene therapies – for Helixmith up to Phase III (campaign mode & multiyear supply)

Wacker Biotech GmbH

Hans-Knöll-Strasse 3
07745 Jena
Germany
+49 3641 5348-0

Contact Location