Environmental Health and Safety Offers a Biosafety Risk Assessment for a Theoretical Model of a Gene Therapy Process Transfer from Research and Development to Large-Scale Manufacturing.

Simon GodwinShana ElkindTimmy CareyKimberly DiGiandomenicoAlexa BalboJemma BlocksidgeJessica OlsonJess MikloskoLeo NjongmetaFrancine PrestonRachel Hodges

Published in: Applied biosafety : journal of the American Biological Safety Association (2023)

We have used an established risk assessment guide to show how cGMP compliments and augments biosafety containment. We provide justification for downgrading from BL2 to BL1 for clinical and commercial cell and gene therapy manufacturing with human cell lines.

Keyphrases

gene therapy
risk assessment
human health
endothelial cells
heavy metals
public health
single cell
nitric oxide
healthcare
cell therapy
induced pluripotent stem cells
mental health
health information
pluripotent stem cells
protein kinase
health promotion
social media