Creating Tomorrow's Solutions
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 and mRNA-based vaccines, polysaccharides (including activation and conjugation), and plasmid DNA.
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.
In addition to recombinant protein manufacturing, Wacker Biotech Amsterdam is the center of excellence for live microbial products, microbial and mRNA-based vaccines and fill & finish within the manufacturing network. The facility is certified up to biosafety level 2.
Process Transfer & Development Capabilities:
7 – 20 L glass, stirred-tank fermenters
GMP Manufacturing:
250 L stirred single-use bioreactor, 1,500 L stainless steel stirred-tank fermenter, dedicated purification lines
In addition to recombinant protein manufacturing, Wacker Biotech Halle is WACKER’s competence center for in-vitro protein refolding, supporting all other sites in development and optimization projects.
Process Transfer & Development Capabilities:
4 x 5 L Quad System Biostat B, 2 x 15 L Biostat C stainless steel stirred-tank fermenters, 150 L stainless steel stirred-tank fermenter
GMP Manufacturing:
1,500 L stainless steel stirred-tank fermenter, dedicated purification lines
Go to Halle site
In addition to recombinant protein manufacturing, Wacker Biotech Jena helps its sister sites with extensive expertise in soluble protein secretion by ESETEC® .
Process Transfer & Development Capabilities
4 x 3 L Quad System Biostat B, 1 x 6 L Biostat A plus, 2 x 30 L Biostat C stainless steel stirred-tank fermenters
GMP Manufacturing
350 L stainless steel stirred-tank fermenter, dedicated purification lines, dedicated suite for cell bank manufacturing
Go to Jena site
Wacker Biotech US operates a 650-liter-capacity stainless steel fermentation line and 43 L stirred single-use bioreactors for the manufacture and purification of plasmid DNA (pDNA). Further small-scale fermentation and downstream processing facilities for pDNA are currently under construction at the site. The company is supported by staff members who have several decades of experience ranging from clinical start-up to commercial product companies.
Process Transfer & Development Capabilities:
Dedicated process development lab focusing on pDNA (strain generation, process transfer / optimization, process characterization, troubleshooting)
GMP Manufacturing
43 L stirred single-use bioreactors
650 L stainless steel stirred-tank fermenter
Continuous cell lysis
Dedicated purification lines
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.
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.
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:
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. Our PLASMITEC® technology, corresponding primary recovery and downstream capabilities are available to suit various customer needs along the manufacturing path.
