Closure analysis of a mock autologous cell therapy process

Closure analysis of a mock autologous cell therapy process

Cell therapy manufacturing comprises several open and manual operations, which increase the risk of contamination. To address this risk, BioPhorum’s Cell & Gene Therapy Commercialization Workstream has generated a ‘mock’ process detailing the manufacture of a...
Cell and gene therapy validation challenges

Cell and gene therapy validation challenges

The purpose of this paper is to highlight the numerous challenges in validating cell and gene therapy (CGT), drug substance (DS) and drug product (DP) manufacturing processes and analytical methods. It is not intended to be a comprehensive overview of all stages of...