By Derek Pendlebury
Recent FDA approvals of cell and gene therapies (CGTs) are the green light for tackling the manufacturing challenges of these new offerings. Key needs for manufacturing CGTs are speed, sterility, and reduced costs. Industry experts expect single-use technologies (SUTs) to deliver on those needs for CGTs like they do for commercial production of biopharmaceuticals. Choosing the right SUTs for each therapy will require a steep learning curve. But CGT makers do not need to start from scratch. They can adopt lessons from the processing of biologic drugs which have some similar needs.
While SUTs are used for development of CGTs today, those used at the laboratory scale cannot always transfer into commercial manufacturing for a variety of reasons, including extractables, leachables, supply chain security, reproducibility, and scalability. The industry needs to overcome these challenges and develop solutions in the near future to avoid capacity shortages.
The scope of this paper does not permit exploration of all SUTs, but instead focuses on one important SUT decision — fluid connection technology. This is one of the most important, but often overlooked, decisions when developing a single-use-based process.