Author Archives: Brian Gazaille

eBook: Bioreactor Scale-Up: From Pilot to Commercial Scale in the Modern Era

Upstream bioproduction always has begun with laboratory systems producing limited amounts of product for test purposes, then those bioprocesses are scaled up to make more product more efficiently for larger clinical trials — and ultimately commercial distribution. With the advent of single-use technology and continuous processing, how have scale-up approaches changed in recent years, specifically at the pilot-to-production level? In this online exclusive, BPI editors review the science and technology affecting decisions made at this stage of process development, with…

eBook: Autologous Cell Therapies: Commercialization Strategies

Autologous cell therapies are derived from a patient’s own stem cells, typically collected from bone marrow. Those cells are then cultured, expanded, and reinfused back into the patient. Unlike allogeneic cell therapies, this process is repeated for each dose and for one patient. The one-to-one process carries several challenges to commercialization, including high development costs, the need to control the risks of manual processing, and compliance with strict timelines. This eBook presents two perspectives on addressing these challenges. The first…