Your Strategy To Manufacture, No Longer A One-Size-Fits-All

By Olivier Loeillot

Medicine is no longer one-size-fits-all. Your strategy to manufacture it, shouldn’t be, either.

Healthcare—and accordingly, biopharma--- is changing and improving every day. Biopharmaceutical companies are moving away from the one-size-fits-all blockbuster pharmaceutical model toward increasingly more innovative, targeted biologics that deliver better patient outcomes. In fact, the number of new biologics the U.S. FDA has approved each year has gone from three per year since the 2004-2008 timeframe to more than 20 in 2018 (1). The pharmaceutical industry is also investing heavily in increasingly more precise medicines with major acquisitions in novel gene therapy companies such as Spark Therapeutics (Roche) and AveXis (Novartis). Biologics and cell therapies may not completely replace larger biopharma operations, but with this level of investment, they appear to be here to stay. Of course, that means the tried-and-true model of traditional big batch manufacturing must change as well.