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34 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 P h a r mTe c h . c o m Operations C ell-culture contamination is a common challenge facing cell-culture laboratories, with consequences that range from minor to devastating. Every effort must be made to protect the integrity of cell cultures, both for the ex- periments that are being performed in the laboratory, as well as to prevent problems later on, downstream. When selected and designed correctly, biological safety cabinets (BSCs) play a critical role in pro- tecting cell cultures, laboratory personnel, and the environment. Selecting a BSC requires careful consideration of many factors, in- cluding the performance criteria important to the laboratory in which it will be used, and the service support that the vendor will provide following installation. In recent years, BSC technology has improved significantly, and vendors are offering more features that allow users to make better decisions, such as enhanced monitoring features (e.g., interfaces that provide a visual depiction of airf low in real time) to help operators maintain an aseptic laboratory environment. However, the efficacy of a BSC is only as strong as its weakest link in a complex and multi-faceted operating process. This article summarizes the key criteria for assessing BSC performance so that it prevents contamination. The implications of cell culture contamination The wide variety of potential biopharmaceutical contaminants and their sources show just how vulnerable cell-culture laboratories are. Contaminants may be classed as biological (e.g., bacteria, fungi, mycoplasma, viruses), chemical (e.g., endotoxins, detergent wash residue, trace concentrations of metal ions, chemical disinfectants), David Phillips is senior global product technology specialist for Thermo Fisher Scientific's Clean Air division. RYANKING999 - STOCK.ADOBE.COM Minimizing Contamination During Biopharma R&D David Phillips The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell- culture contamination.