How To Mitigate Cell And Gene Therapy Manufacturing Risks Amplified By The COVID-19 Pandemic

By Rupa Pike, Director of Enterprise Science and Innovation Partnerships, and Nidhi Sharma, Head of External Collaborations Cell & Gene Therapy, Thermo Fisher Scientific

According to a study published by McKinsey & Company in June of 2020, there were more than 750 ongoing clinical trials in the cell and gene therapy (CGT) space involving  30,000 patients.1 A 2021 report from Alliance for Regenerative Medicine stated that there are 504 clinical trials for cell-based therapies with 133 trials in Phase 1, 295 in Phase 2, and 76 in Phase 3.2 The same report indicated a total of 294 clinical trials in gene therapy with 72 in Phase 1, 176 in Phase 2, and 46 in Phase 3. CGT products account for approximately 12% of the pharmaceutical industry's clinical pipeline and 16% of its pre-clinical pipeline.3 These numbers tell a compelling story.

While the biopharmaceutical industry has been greatly affected by the COVID-19 pandemic, the CGT space has seen the most impact. Industry experts believe this is due to the complexity of CGT manufacturing and delivery process as well as its lack of standardization and scalability, especially when compared to the traditional manufacturing model for biologics and monoclonal antibodies. Particularly, autologous therapies are even more complex with sparing starting materials, heterogeneity of cells, diverse manufacturing workflows, and a circular supply chain. Download the full article to understand the various ways the COVID-19 pandemic has disrupted the CGT industry as well as what strategies CGT manufacturers can implement to optimize and digitalize their supply chain in order to overcome these growing issues.