The Challenges Of Biopharmaceutical Quality

Today more than ever, the quality functions in biopharmaceutical manufacturing are under pressure.  And that pressure is unlikely to be relieved any time soon due to an unprecedented level of regulatory and political scrutiny (primarily from the U.S. FDA and EMA) combined with a global market rife with a multitude of complex quality standards. It’s a scenario that has quality professionals struggling to embrace new and more efficient ways of manufacturing while maintaining compliance.

In the following Q&A, Samsung Biologics answers some important quality-related questions regarding biopharmaceutical manufacturing that you will likely find helpful.