Over the past two years EHS & Biosafety (EHS&B) subject matter experts from over 15 global biopharmaceutical industries have met to share and discuss emerging trends and challenges in the field of Cell & Gene Therapy (CGT). Their first focus was the safe production, within the manufacturing area, of commercial scale volumes of drug substances for human trials or as therapeutic drugs. In this video Kim diGiandomenico (AstraZeneca) discusses ”Environmental health and biosafety risk assessment guidance for commercial scale cell and gene therapy manufacturing”.https://journals.sagepub.com/doi/10.1177/1535676020946235
The paper identifies, shares, and enhances best practices and standards from other modalities with the aim of improving risk controls and increasing the speed of learning of the industry. The video also shares the current effort of the team to provide additional tools for the industry e.g. a number of model completed risk assessments and template safety data sheets.
Watch this video if you are interested in learning more about how the work of this team could help with your day to day role in EHS and Biosafety. New members and feedback are always welcome.