
FDA's Francis R.W. Godwin (CDER) and Kathleen Jones, PhD (CBER) detail a record pace of drug warning letters and the CGMP deficiencies most commonly cited in biologics facility inspections.
Sterile filtration is essential within many steps of a bioprocessing operation, both upstream and downstream, ensuring the biopharmaceutical product’s proper performance, safety, and quality. When seeking to maximize filtration efficiency, it helps to understand how sterile filtration and single-use systems work together, as well as how optimizing the filter design for specific applications can enhance performance.






