07.18.23 -- Mitigate Risk Through Effective Impurity Characterization

Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants, presenting a risk of toxicity. The first challenge chemists address is to narrow the focus on the most likely suspects. Expert efforts to identify, quantify, and ultimately minimize any impurities can improve product safety and regulatory success.

Explore the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal. Fate and purge studies can expose other CPPs or indicate the downstream removal of a CQA from a drug substance, ultimately providing an understanding of impurity formation and improving end product quality.

A forum of industry experts discusses topics including early development outsourcing strategy, supply chain security, and how to foster mutually beneficial relationships between sponsors and vendors. This conversation also sheds light on risk mitigation and time-saving approaches that have shown efficacy in building and managing drug development.

A 360-degree approach entails full CMC development and analytical release testing in support of biopharmaceuticals in development and in clinical trials. Outsourced testing also ensures biopharma clients can change manufacturing partners between early development and commercial production while having their analytics needs reliably fulfilled in one place.