In 2020, the Cell and Gene Therapy Phorum published an article Environmental Health and Biosafety Risk Assessment Guidance for Commercial-Scale Cell and Gene Therapy Manufacturing*.
This identified best practices and improved risk controls to consider when setting up a commercial-scale cell and gene therapy manufacturing line – from an EHS perspective.
The paper has a companion risk assessment template that is freely available on the BioPhorum website. This highlights the complexity of commercial-scale manufacturing, areas to assess, potential questions to ask, and other parties who may input to the risk assessment.
The team has now published the first in a series of follow-up articles considering real-world scenarios where the risk assessment has been completed.
This first 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.
Using the article and latest completed template as a guide, users can download and complete their own templates and have a framework to develop their experience using a model that can be adapted for their own CGT EHS processes.
In the future, BioPhorum will publish completed templates using different scenarios and will, for example, look at moving cells from R&D into the manufacturing environment and what changes are needed, e.g. GMP considerations, other staff training matters, HVAC, etc.
*DiGiandomenico et al., Applied Biosafety 2020; vol 25 No. 4.