To date, there has been a reluctance for cell therapy manufacturing facilities to move away from Grade B manufacturing suites even with the implementation of closed processing or the use of isolator technology. Read this article, “Cell Therapy and Closed Process Manufacturing” by Stephen Judd to learn about the potential to effectively operate cell therapy facilities in lower grade cleanroom...
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies is accelerating, introducing tough decisions for manufacturing development. Gene editing therapy production is complex, often involving multi-modality manufacturing operations in one facility to produce a single therapeutic. This article considers whether retrofitting an aging monoclonal...
Cell and gene therapies (C>) have unique needs in manufacturing suites that differ from those for classic product biopharmaceuticals. Facilities must be created with flexibility in mind, able to run multiple products and production types to remain viable.
