Question:
What is a biological safety cabinet? Do we need one to prepare our gene therapy product?
– Clinical Pharmacist, Medical Center
Answer:
Biological safety cabinets (BSC) are enclosed workspaces that are used to work safely with infectious biological materials. Class II BSCs are the most common type used in research and clinical settings, and these BSCs use a combination of directional airflow and high-efficiency particulate air (HEPA) filters to provide personnel, product, and environmental protection. Room air is drawn into the front of the BSC, which keeps potentially hazardous aerosols generated during work away from the user, thereby providing personnel protection. The room air is diverted under the work surface and through a rear plenum powered by an internal blower. Depending on the type of Class II cabinet in use, a certain percentage of that air is passed through a HEPA-filter and recirculated into the BSC in a unidirectional, laminar airflow pattern, thereby providing product protection. Finally, a dedicated HEPA filter exhausts the remaining percentage of the air from the BSC back into the room or outside of the building through the facility’s exhaust system, thereby providing environmental protection.
BSCs should be used when working with potentially infectious biological materials, and there is a procedural-related risk of generating aerosols, droplets, or splashes that may occur during pipetting, centrifugation, or vortexing. The hazardous characteristics of the gene therapy product in use will often dictate whether a BSC is required for study agent preparation, and this requirement will generally be noted in the sponsor-provided pharmacy or investigational product manual. The Institutional Biosafety Committee (IBC) is also responsible for assessing the risks associated with handling the gene therapy product and determining appropriate mitigation measures, which may include the use of a BSC. For example, the use of a replication-competent, infectious herpes virus vector will generally require that the gene therapy product is prepared inside a properly certified BSC, while preparation of a replication defective, non-infectious adeno-associated virus vector can generally be conducted on a countertop while wearing proper personal protective equipment. In some cases, the gene therapy product may be prepared inside a BSC primarily to maintain product sterility, although there may be minimal concerns related to personnel exposure. It is important to note that laminar flow hoods, or clean benches, should not be used to prepare biological materials. Although laminar flow hoods provide product sterility by directing HEPA-filtered air across the work surface, this air is blown directly into the face of the user, so no personnel protection is provided.
References
- Appendix A – Primary Containment for Biohazards: Selection, Installation, and Use of Biological Safety Cabinets. Biosafety in Microbiological and Biomedical Laboratories, 6th Edition, Centers for Disease Control and Prevention/National Institutes of Health, June 2020. https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf.
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