Production of cGMP-grade and non-cGMP-grade bulk material in BL1 and BL2 qualified laboratories (final dosage form): media design and optimization; development of synthetic or defined media for fermentation or cell culture; cell culture adaptation to serum-free or protein-free media; process development, optimization and scale-up; process validation; production.
|
Microbial fermentation
IBA Biologics offers a comprehensive range of cultivation and primary separation options for microbial processes from laboratory scale up to production scale.
Expertise and capabilities
- Development of recombinant production strains
- Production of cell banks (MCB/WCB)
- Adaptation of strains to defined synthetic media
- Development of microbial cultivation processes
- Process scale up to 200 L (cGMP, BL2) or 2 m3 (non-cGMP, BL1)
- Development and validation of analytical procedures for in-process controls
- Strategy development for harvesting and primary separation
- Unit operation and process validation
- Toll/custom fermentation (non-cGMP and cGMP)
- Full documentation
- Organisms: E. coli, S. cerevisiae, P. pastoris, etc.
|
Animal cell culture
We are able to offer a large range of animal cell culture services, including gene cloning into suitable expression systems, cultivation in various bioreactor geometries (stirred tank, airlift and hollow fiber) and aeration systems (conventional and bubble-free).
Expertise and capabilities
- Optimization of culture conditions; development of feeding and/or bleeding strategies
- Adaptation of processes/cell lines to synthetic media (serum-free and/or protein-free)
- Production of master (MCB) and working cell banks (WCB)
- Development of recombinant Baculovirus stocks for insect cell culture
- Process development and up-scale
- Custom cultivations (non-cGMP and cGMP)
- Development and validation of analytical procedures for in-process controls
- Full documentation
- Organisms: CHO, BHK, SF9, Hi5, HeLa, hybridoma etc.
Order information
for a quote please contact info@iba-go.com
|
