Scaling Up Gene Therapy Manufacturing With Single-Use Technology

By Tony Hsiao, PhD, Senior Product Manager, Thermo Fisher Scientific

In recent years, the biopharmaceutical industry has increasingly placed special focus on the development of sophisticated gene therapies to treat, prevent, or potentially cure a broad range of life-threatening and life-changing diseases. Nevertheless, implementing traditional scale-up processes in the gene therapy manufacturing environment can be challenging. With product integrity and safety remaining the highest priorities, gene therapy manufacturers are actively looking for ways to optimize their processes to allow for capacity scalability.

Single-use technology (SUT) offers several benefits, which gives it the potential to play a fundamental role across the full spectrum of gene therapy manufacturing workflows, from liquid handling to use with bioreactors and purification systems. However, the abundance of singleuse technologies available means gene therapy manufacturers face a pressing dilemma over choosing the technology that will best meet their needs and allow them to scale to their target operation sizes.

This article will discuss the top five key considerations gene therapy manufacturers need to take into account to make the best possible choice for their SUT equipment and supplier: (1) the target cell culture, (2) the transfection process, (3) the product purification process, (4) the plasmid and reagent supply, and (5) the quality and performance of single-use consumables.