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, Nick Beaumont, VP and managing director of Samsung BioLogics who is responsible for the Quality Assurance Center of the company, answers some important quality-related questions regarding biopharmaceutical manufacturing that you will likely find helpful.
Q. Explain the importance of understanding all the nuances related to how raw materials can affect product quality.
Beaumont: In biopharmaceutical manufacturing, the process involves growing live cells under optimal conditions. The cells can be very sensitive to environmental changes but also to the variability of trace elements in the growth medium or in the product contact surfaces of filters, single use hoses, and aseptic connections. The cell growth media selection is a key development activity used to identify the media components that provide the optimal cell growth and cell viability performance under controlled design of experiments. Raw material variability may occur as a result of changes in the vendor ...