The recent FDA warning letter to Sanofi highlights a critical issue in biopharmaceutical manufacturing: the integrity of single-use systems (SUS) and the prevention of leaks. This incident serves as a stark reminder of the importance of robust control strategies in bioprocessing, particularly when it comes to high-pressure events and product leakage. The Sanofi Case: A … Continue reading Leaks in Single-Use Manufacturing: A Critical Challenge in Bioprocessing