Decoding AAV Manufacturing: Navigating Critical Quality Attributes And Their Analytics

Ask the expert with Roland Pach

For adeno-associated virus (AAV) gene therapies to be consistently safe and effective, they must meet stringent quality standards throughout their complex manufacturing. These standards are formally defined by critical quality attributes (CQAs) – essential characteristics like identity, safety, quantity, purity, and potency, as outlined by ICHQ10 guidelines. However, accurately measuring these CQAs presents a significant challenge, particularly in distinguishing fully packaged therapeutic viruses from impurities.

Traditional analytical methods such as HPLC and optical density measurements often require substantial optimization for improved detection limits, quantification, and baseline separation, and may lack GMP compliance. New techniques are constantly being developed. In this article, global analytics expert Roland Pach from Roche shares valuable insights on these vital CQAs, discussing current analytical tools and emerging technologies like mass photometry. Read further to learn more.