Biosafety risk assessment template for manufacturing and processing of biological materials

The biopharmaceutical industry is expanding exponentially, with a focus on getting cell and gene therapy products to market as quickly and safely as possible for the benefit of patients. One of the main impediments can be timelines around facility build, fit-out, and various certifications. If some operations are deemed acceptable to be performed in a Biosafety Containment Level 1 (BL1) environment, it may allow retrofitting of existing facilities to facilitate quicker manufacturing timelines.

Published in the Journal of Applied Biosafety, the paper gives you a strategy by which a manufacturing process with a BL2 designation can be downgraded to BL1. The principles of the downgrading process are based on the robust contamination controls in clinical and commercial manufacturing that typically are not part of R&D processes. These strict requirements and the application of cGMP principles provide a framework by which processes can be suitably managed and controlled to mitigate biohazard risk, specifically for cell lines that may be contaminated with human pathogenic viral agents.

We demonstrate how a risk assessment guide can be used to define the risk profile of a theoretical process with a human cell line intended for clinical/commercial application. Based on the risk assessment, key BL2 elements were identified as suitable for downgrading, including facility containment controls, emergency spill response plans, and storage and shipping requirements.

This  accompanying Biosafety risk assessment template for manufacturing and processing of biological materials  can be downloaded and used to assess and mitigate biosafety risk for human-derived cell lines susceptible to adventitious agents.

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• File Size 276.85 KB
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• Create Date 1st September 2023
• DOI https://doi.org/10.46220/2023CGT008
• Last Updated