GMP Manufacturing

With over 30 years' experience producing microbial-derived proteins and vaccines, Wacker Biotech is a world-leading partner when it comes to manufacturing microbial biopharmaceuticals for our customers.

Production lines in Jena, Halle (Germany), Amsterdam (The Netherlands) and San Diego (USA) are equipped with single-use bioreactors, as well as with stainless-steel fermentation vessels ranging in volume up to 1,500 liters. Corresponding primary recovery and downstream capabilities are available to suit various customer needs along the development path.

GMP facilities

• 43 L stirred single-use bioreactors
• 250 L single-use bioreactor with associated downstream processing
• 350 L stainless-steel fermenters with several separate downstream processing suites
• 650 L stainless-steel fermenters with several separate downstream processing suites
• 1,500 L stainless-steel fermenters with several separate downstream processing suites
• BSL 1 and 2

With over 30 years' experience, Wacker Biotech has profound expertise in the process development and manufacturing of a variety of vaccine products, including live attenuated, inactivated, (conjugated) polysaccharide and mRNA- and protein-based vaccines.

Production lines in Jena, Halle (Germany), Amsterdam (The Netherlands) and San Diego (USA) are equipped with single-use bioreactors, as well as with stainless-steel fermentation vessels ranging in volume up to 1,500 liters. Corresponding primary recovery and downstream capabilities are available to suit various customer needs along the development path.

GMP facilities

• 43 L stirred single-use bioreactors
• 250 L single-use bioreactor with associated downstream processing
• 350 L stainless-steel fermenters with several separate downstream processing suites
• 650 L stainless-steel fermenters with several separate downstream processing suites
• 1,500 L stainless-steel fermenters with several separate downstream processing suites
• BSL 1 and 2

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 is a pioneer in new field of live biotherapeutic products, which are products containing whole, live microorganisms, such as bacteria and yeast, with an intended therapeutic or preventive effect in humans (administered orally, topically, intravenously, etc).

Wacker Biotech has over 10 years of specialist experience working with live biotherapeutic 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). Wacker Biotech has experience in working with many different types of live biotherapeutic products, helping its customers to create a robust and controlled process and 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 biotherapeutic products at Wacker Biotech include:

GMP facilities

• 250 L single-use bioreactor with associated downstream processing
• 350 L stainless-steel fermenters with several separate downstream processing suites
• 1,500 L stainless-steel fermenters with several separate downstream processing suites
• BSL 1 and 2

Our production sites are supported by staff members who have several decades of experience in pDNA production (GMP), ranging from clinical start-up to commercial product companies. Fermentation, downstream purification, including continuous lysis, and pDNA quality control, are part of our proprietary platform.

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.

Our customers benefit from our 20 years’ experience in the production of plasmid DNA, including the manufacture of pDNA-based VM202 products for gene therapies – for Helixmith up to Phase III (campaign mode & multiyear supply).

Our PLASMITEC^® technology and corresponding primary recovery and downstream capabilities are available to suit various customer needs along the manufacturing path.

GMP facilities

• 43 L single-use bioreactors with associated downstream processing stream
• 650 L stainless-steel fermenter with associated downstream process stream
• 1,500 L stainless-steel fermenters with several separate downstream processing suites

Wacker Biotech offers production of mRNA-based products from a single source: from pDNA as starting material up to mRNA production, including LNP formulation.

Large-scale production capabilities for mRNA process transfers are available at our GMP facility in Amsterdam, the Netherlands.

The new mRNA competence center at Wacker Biotech in Halle is a fully equipped, stocked and dedicated facility to produce GMP-grade mRNA (including pDNA template and LNPs) meeting the highest standards of regulatory compliance and quality. This additional GMP unit is an extension of our commercial GMP site in Halle, leveraging decades of experience in biopharma manufacturing. Key features of the mRNA expansion include:

• 1,600 m2 clean room area
• 400 m2 lab space quality control
• 4 production lines with different IVT scales
• 2 x 30 L and 2 x 3 L to meet different demands depending on development stage and dosing
• g to kg scale within a few months
• Flexibility based on fast-track supply of raw materials
• Equipment aligned with state-of-the-art production processes