Wackey Wackey Sleepyhead- A case study in adapting Single Use Bioreactors to a sensitive cell line

摘要

Single Use Bioreactors have been in vogue for almost a decade. Characterization of films and adaptation of bioreactor preparation to accommodate sensitive cell lines is still a challenge and our Industry continues to invest in analytical technology for root cause analysis. This effort, in turn, can result in more stringent requirements that can be levied as part of new film/bioreactor qualification. The case study presented here details the challenges posed by a sensitive cell line, root cause assessment, interim and long term solutions.