NEXT GENERATION MANUFACTURING FOR BIOLOGICS: INTEGRATION OF A HYBRID MODEL FOR CONTINUOUS MANUFACTURING CONCEPTS INTO A CLINICAL FACILITY

摘要

The "one size fits all" concept is rarely applicable in life, this is also true for the concept of continuous manufacturing where specific applications will differ based upon the requirements of the end user. This is the scenario we describe here in which aspects of continuous manufacturing for both upstream and downstream biologies manufacturing are being incorporated to address the current pipeline needs within Bristol-Myers Squibb. The application is for stable, easily expressed monoclonal antibody processes that require moderate volumes and throughputs, such as for most oncology or immuno-oncology therapies. However, this is countered by challenges of an expanding pipeline that necessitates looking beyond the current platform philosophy for how to modify the process with the goal to increase overall productivity in a flexible manner.