Process development innovations to improve gene therapy manufacturing

Cell & Gene Therapy Insights 2022; 8(3), 541–548

DOI: 10.18609/cgti.2022.081

Published: 9 June 2022
Jessica Hilmoe, Michael Shen

As viral vector-based gene therapies move toward indications with larger patient populations, the pressure to improve manufacturing efficiency is rising. To support efficient manufacturing, therapeutic developers must begin by putting a robust process development (PD) plan in place. The industry has been working towards a robust PD plan using innovations such as templated processes to improve yield whilst reducing costs of goods sold (COGS) and time-to-clinic. Templates will help, but there will always be a need for PD to optimize the upstream/transfection, as well as downstream due to differences in the gene of interest (GOI). In this article, we will discuss the PD innovations that Merck’s teams have worked on to improve manufacturability, robustness of analytical testing, and scale-down models, all with a view to meeting the needs of large-scale viral vector manufacturing.