BPDF Downstream Manufacturing
Harvested material is processed according to PBRs generated during process development or provided by the client. In general, purification is accomplished using column chromatography, ultrafiltration/diafiltration, or other product-specific unit operations. All aspects of buffer preparation, equipment preparation, process conditions for each purification step, in-process and release testing, and product bulking and storage are detailed in the PBRs.
Our staff has extensive expertise and experience optimizing and scaling-up many different operations such as cell disruption, lysate clarification, product capture, purification, and polishing steps. Purified product is bulked into client approved containers and stored at appropriate conditions in monitored controlled chambers.
- Column chromatography
- Ultrafiltration TFF
- Controlled temperature reactions
- Enzymatic digestions
- Low endotoxin production of recombinant proteins and other biomolecules.
- Aerobic and anaerobic fermentation up to 80L.
- Ultra-low temperature product storage.