How Beta-lactams Can Pose A Risk To Your Cell And Gene Therapies

Beta-lactams are widely used antibiotics that pose a significant, life-threatening allergic reaction risk to patients. For cell and gene therapy manufacturers, this risk is compounded by the difficulty of detecting trace amounts of beta-lactams and the lack of a known minimum dose required to cause a reaction. Regulatory bodies like the FDA and EMA mandate stringent controls to prevent contamination, requiring comprehensive separation of facilities and processes that handle beta-lactams from all other drug manufacturing. Even raw materials—like recombinant proteins that may use beta-lactams as selection markers—can carry a residual risk. If these contaminated materials are used in your culture protocols, residual beta-lactams could end up in your final drug product. Understanding these risks is critical for developing a robust strategy to protect your patients and ensure regulatory compliance.

Read the full article to learn more about the regulatory landscape and how to mitigate the risk of beta-lactam contamination in your cell and gene therapy manufacturing.