Live Biotherapeutic Products
With its LIBATEC platform, Wacker Biotech offers its customers vast experience in process development and optimization, as well as in the manufacturing of live biotherapeutic products (LBPs). EMA/FDA-approved production lines are available for this, with volumes ranging from 250 L (single-use reactor) to 1,500 L (stainless-steel fermenter).
The LIBATEC® platform is suitable for a wide range of LBPs and fermentation regimes, allowing aerobic as well as specific anaerobic bacteria to be used. Wacker Biotech can set up and run closed production systems (monoseptic processing), ensuring maximum culture purity and allowing specific routes of application, such as parenteral administration.
Our proven track record and experience in the LBP field allows us to meet the requirements of any project at every development phase. Our expertise extends to:
- Replacing animal-component-containing media
- Maintaining cell viability throughout the production process by developing new freeze-drying cycles if necessary
- Process characterization, process validation, clinical and commercial GMP manufacturing experience with LBPs
Following upstream and downstream processing, the bulk drug substance or drug product can be filled into vials or freeze-drying trays. Integrated drug product production, including lyophilization, provides a seamless manufacturing process, which may be critical in cases where there are limited hold times between cell harvesting, filling and storage. Wacker Biotech performs aseptic filling within the GMP fill & finish facility, which includes both formulation / preparation and the main filling area, supporting batch sizes up to 20,000 units (DIN 2R to 20R) and bulk lyophilization runs up to 65 L.
More about LIBATEC®