Risk assessment of cells used in early development
This paper should be read in conjunction with the Environmental health and biosafety risk assessment framework for commercial scale cell and gene therapy manufacturing and template. This paper is the first in a series considering real-world scenarios where the EHS companion risk assessment template has been completed. This assessment focuses on cell expansion operations working with the cell line only in R&D labs to develop procedures and controls; it does not include production operations, such as transfection or viral infections.
Completing the templates will share experience, help people learn and build consensus across the industry, covering as many CGT-specific processes as possible. There is a wealth of knowledge of risk assessments in the small molecule arena, but there are many unknowns in the CGT world. As with other areas of CGT, general biologics’ processes and controls cannot just be reused.
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- Create Date 10th September 2021
- DOI https://doi.org/10.46220/2021CGT002
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