Phase 3 and Commercial Projects
Defined the causes of poor protein production yields and characterized the instability of the master cell bank under specific growth conditions for a Phase 3 product.
Audited a publicly traded company’s production capability and characterized needed upgrades to meet current regulatory and CMC requirements.
Defined current practices for Baculovirus/Insect Cell antigen production and trained a diagnostic company's operators, enhancing viral and protein yield. Developed product appropriate purification processes.
Implemented a fermentation parameter which increased drug substance yield >50%.
Trained regional sales forces on multiple product applications for a national company.
Implemented process yield improvements achieving COG targets.
Identified and characterized a temperature sensitive mutation that resulted in production run failures. Developed process modifications circumventing future run failures with the same Cell Bank.
Supported large scale formulation with key equipment and processing parameters.
CMO Support Projects
Identification of multiple process solutions for an International CMO needing to rapidly increase cell paste harvest and freezing capability.
Defined production scale disc stack and tubular bowl centrifuges for a North American Contract Manufacturer. Developed fermentation oxygen enrichment schemes and the associated equipment for the same CMO.
Supported a CMO with details for appropriate equipment to minimize product shear.
Identified fermentation parameters resulting in low product yield. Supplied details that not only resulted in increased product production but minimized downstream issues.