What Does it Take to Scale Cell and Gene Therapies from Discovery to Commercialization

Cell and gene therapies (CGT) continue to advance in the pharmaceutical industry. Despite continued investment in R&D, the space still faces significant barriers. Primarily, the expensive nature of the treatments and complexity of manufacturing them.

Maher Masoud, CEO of MaxCyte, spoke with Pharmaceutical Executive about the CGT space and how the industry is working to move past these barriers. Advancements in platform technology are allowing companies to more efficiently partner with manufacturers to improve those processes, while new areas of research (such as non-viral cell engineering) are opening new possibilities.

Pharmaceutical Executive: What will it take to scale cell and gene therapies from discovery to commercialization?
Maher Masoud: What it takes in this environment is developers that can work with manufacturers that have the ability to scale from R&D to commercial. What I mean by that is working where you're not having to re-optimize processes on a regular basis and not having to start from scratch every time you're working with a manufacturer.

That's what it’s going to take for this industry to have developers come together with best-in-class platforms that have the ability to do optimized processes early in research, and then translate that from that early research optimization into a clinical platform so that a clinical process that can make it all the way to commercialization.

In this environment, you must work with across-the-board, unit manufacturing operations, where you're recreating the wheel each time. It makes it very difficult for developers. The science is there.

If you look where we are right now, we have a lot of curative products out there for oncology and rare genetic diseases. But being able to work with developers that have done it in the past, and have been in the clinic multiple times, is going to be the key for what developers need to do, which is work with seamless, automated and scaled up processes.