Our system has noticed that you are based in , but the current country setting is . Do you still want to change your country?

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 customers also benefit from our ‘one-stop-shopping’ service which offers GMP cell banking, development, production and filling (fill & finish) for drug substances and drug products, as well as providing program flexibility, time reduction and cost reduction.

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 and mRNA-based 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. You can use the drop-down menu at the top left of the screen to 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.

Wacker Biotech US In San Diego

Wacker Biotech US, headquartered in San Diego, California, is a pharmaceutical contract manufacturer of plasmid DNA (pDNA). Relying on decades of experience in process development, clinical and commercial manufacturing of protein therapeutics within the global Wacker Biotech organization, the San Diego site now extends its offering to the production of recombinant proteins, operating a 650 L stainless-steel fermentation line and 43 L stirred single-use bioreactors. The new capabilities enable processes transferred from the client or using Wacker Biotech’s proprietary ESETEC® secretion platform.

Wacker Biotech US is ideally positioned to serve US-based clients.

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

Vaccine Manufacturing | Extensive Experience and Strong Track Record PDF, 394.7 KB | English

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

  • mRNA-based 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

LIBATEC® – The Technology for Live Biotherapeutic Products PDF, 223 KB | English

Wacker Biotech has over 10 years of specialist experience in 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). 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 biotherapeutic 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 biotherapeutic 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 biotherapeutic 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.

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).

The production site in San Diego is equipped with 43 L single-use bioreactors and 650 L stainless-steel fermentation vessels. 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

The future mRNA competence center at Wacker Biotech Halle is a fully equipped, stocked and dedicated facility to produce GMP-grade mRNA (including pDNA template and LNP’s) meeting the highest standards of regulatory compliance and quality. This additional GMP unit in Halle is planned to be operational by Q1/Q2 2024. It 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

Quality Control

Our state-of-the-art microbiology, biochemistry and analytical chemistry labs offer certified analytical methods for biologics characterization of both drug substance and drug product. We offer validation of the analytical methods in accordance with current validation requirements, as outlined in the ICH Q2 guideline for the validation of analytical procedures.

We follow GMP guidelines and meet the regulatory authorities’ requirements for the analytical determination of your product’s general characteristics, molecular structure determination, identity, activity, purity and safety, as well as the stability of the produced therapeutic proteins, vaccines, live microbial products and plasmid DNA.

In our biochemistry and microbiology labs, we carry out the analyses necessary for maintaining our GMP standards on raw materials, water and environmental control.

Our aseptic filling suite consists of a formulation/preparation area as well as the principal filling area, which contains a Flexicon FMB210L Monobloc semi-automated filling machine (filling, stoppering and capping) and an Edwards freeze drier (6 m2). Depending on vial size (DIN 2R to 20R), batch sizes of up to 20,000 vials can be filled.

Wacker Biotech has experience in formulation and lyophilization development and is ready to collaborate with you on the development of your biopharmaceutical drug product. Wacker Biotech has bench-scale equipment for running small-scale processes, to match the large-scale fill & finish equipment in our facility.

Experience in aseptic liquid filling

  • Monoclonal antibodies
  • Recombinant proteins
  • Alum-containing vaccines
  • RNA/DNA
  • Allergy vaccines
  • Live microbial products (LMPs)
  • Diluents and placebos

Experience in lyophilization (bulk or vials)

  • Recombinant proteins
  • RNA/DNA
  • Allergy vaccines
  • Live microbial products (LMPs)

Wacker Biotech GmbH

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

Contact Location