CGT Manufacturing Resolution #2: Explore Novel Partnership & Outsourcing Structures

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

In early December, I invited Katy Spink, COO and managing partner of Dark Horse Consulting, to sit down with me for a discussion on her expectations and predictions for CGT manufacturing paradigms in the new year. But because cross-industry collaboration, face-to-face communication, and transparency are critical in this burgeoning industry (and, let’s be honest, can be a lot of fun), Katy and I were also joined by a small group of CGT manufacturing experts from different companies across the industry.

Our conversation ultimately outlined five best practices — or, more fittingly, New Year’s Resolutions — that companies should embrace in 2022 that will (incrementally) help us define and achieve manufacturing maturity in the future.

In the second of this five-part article, Spink dives into resolution #2, advising companies to explore the increasingly wide variety of outsourcing and partnership models emerging to help companies collaboratively de-risk their manufacturing processes.

In my Life Science Leader magazine 2022 outlook on CGT manufacturing, one expert argued that the outsourcing industry has its work cut out for it to offer CGT biotechs more meaningful solutions and partnership constructs. The Cell & Gene Collaborative discussion with Spink only reinforced this notion that the partnership dynamics emerging in the CGT space are increasingly “out-of-the-box.”

While the question regularly posed in article headlines and from conference podiums is “build vs. buy?” the answer emerging is hardly black and white. In fact, there may even be more “shades of gray” than the increasingly popular “hybrid” approach granting companies external support and the ability to keep certain know-how and capabilities in-house. In an industry like CGT where no one company is taking the same approach to manufacturing, partnerships that are built around shared risk are increasingly valuable. For example, in addition to encountering increasing examples of the “hotel model” (i.e., “rent a cleanroom”), we’re now seeing manufacturing service providers launching that invest in and/or create capacity for multiple companies in return for revenue or milestone rewards. These investments ultimately give two parties — the start-up and the funding/capacity-providing party — a stake in the game.

Spink summed it up nicely: “In a predominantly bespoke space that does not yet have common manufacturing platforms established, it can be difficult for a CDMO’s staff to be trained on multiple different platforms, unit operations, and products from day to day or even within the same day; there’s no consistency there. That’s why these new partnership constructs are particularly meaningful additions to the space; a biotech doesn’t need to invest in a facility that it may not yet need, but it will still have access to a staff that knows and is dedicated exclusively to their individual process.”

Want to add another resolution to your list? Check out resolution #3 here...

Further Reading:

• For more on outsourcing trends and challenges, check out this Cell & Gene Collaborative series featuring NegotiumBio’s Mark Davis: Part 1; Part 2; Part 3
• The “hybrid” outsourcing approach is an increasingly popular topic of discussion; in this Cell & Gene Collaborative blog post, I offer a few thoughts on potential future opportunities the hybrid outsourcing approach presents CGT companies — even those that may be investing early in their own manufacturing capacity.
• For those of you that want your own facility, but can’t swing it just yet, here’s another, perhaps less traditional take on how you can “own your CGT manufacturing destiny” when outsourcing