A Powerful Pairing: Using Mass Spectrometry with Analytical Chromatography

摘要

Biological product and process characterization are not new to this quality by design (QbD) and process analytical technology (PAT) era. In the 1990s we saw the FDA introduce the concept of well-characterized biologies: an acknowledgment that analytical technology had advanced to the point where the bioprocess did not necessarily (or not fully, anyway) define a biopharmaceutical product. That ultimately led to the regulation of some types of products within the United States moving from the purview of FDA's Center for Biologies Evaluation and Research (CBER) to its Center for Drug Evaluation and Research (CDER). Now some biopharmaceuticals go to market through the biologies license application (BLA) process whereas others use the new drug application (NDA) instead. While the regulators were adjusting to this new scientific reality, suppliers of analytical equipment continued to improve their instruments, making it ever more possible for bioprocess engineers to build quality into their manufacturingprocesses by way of PAT and design space definition — as well as ever more precision in product characterization.