Thursday, April 28, 2022 Daily Archives

The Impact of Protein Stability on Virus Filtration

by , and

Filtration of protein-based biologics is essential for minimizing viral contamination and ensuring product safety and high quality. The tendency of therapeutic monoclonal antibodies (MAbs) and recombinant proteins to aggregate under a number of conditions can complicate selection of a virus filter. An increasing demand for high concentration formulations creates additional challenges. When performing filterability studies and to ensure meaningful virus filter evaluations, downstream process scientists must address factors that can lead to aggregation. This special report on virus filtration by…

April 28, 2022

eBook: Intensifying Processes for Monoclonal Antibodies

by , , , , and

The commercial manufacturing success of monoclonal antibodies (MAbs) has become a touchstone of the biopharmaceutical industry. MAbs are so well established that they often are referred to as “traditional†biologics, and well-known MAb processing methods have become a model for processing of other “advanced†or “emerging†therapies. But MAb processing continues to advance as biomanufacturers seek ways to improve efficiencies, lower costs, and (most recently) increase sustainability of facilities. Drug makers are particularly interested in strategies for MAb process intensification.…

April 28, 2022

Genezen fast tracks second phase expansion in US

by

Genezen’s aggressive approach has not been aggressive enough says firm as a second phase expansion begins earlier than expected at its lentiviral vector plant.   Gene therapy contract development manufacturing organization (CDMO) Genezen Laboratories has completed construction of a 75,000+ square-foot lentiviral vector production facility in Indianapolis, US and says the next phase of the expansion is underway. The firm said it had allocated space for future expansions but did not expect to be initiating the next phase of the…

April 28, 2022