Wacker Biotech is leader in the manufacture of live microbial products, which are products containing whole, live microorganisms, such as bacteria or yeast with an intended therapeutic or preventive effect in humans (distributed oral, topical, intravenous etc.).
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 (BDS) and drug product (DP) 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 (SUB) with associated downstream processing stream
- 1,500 l stainless steel fermenter with several separate downstream processing suites
- Several WAVE bioreactors (20 l to 200 l) for use in the production of a range of products, all with associated downstream processing stream