As many biologics will or have come off patent, the opportunity for competition, and potentially lower costs through biosimilars, is created. Barriers to entry, specifically product manufacturing as relatively minor changes in the process impact quality or safety, exist. Coupled with the need for manufacturing flexibility and agility, you are faced with a challenging dichotomy.
In this webinar, we discuss the challenges faced in designing & constructing a single production facility that can produce biosimilar MAbs, from clinical through commercial production. We will look forward 10 to 15 years and consider different production scales utilizing SU equipment in conjunction with flexible facility design, and potential economic impacts.