Kite Exec Reveals Key Ingredient To "Secret CGT Manufacturing Sauce"
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
The dust is slowly settling following the Alliance for Regenerative Medicines’ (ARM’s) Meeting on the Mesa. As I was a virtual attendee this year (fingers crossed for live attendance in 2022!), I’m only just starting to watch the many panels and workshops that caught my eye — starting, of course, with the three manufacturing-centric panels. So far, my favorite, hands-down, was the workshop entitled, “Industrialization of Cell Therapy Manufacturing,” which I’ll no doubt continue to discuss more in depth in the upcoming weeks.
But I wanted to start by sharing one particular quote from that panel because it made me immediately sit up and emphatically circle AND star my notes. If this panel had been a poetry reading, I daresay I would’ve started snapping my fingers. (JK; the movies are lying to you — we poets aren’t that bizarre.)
As the title of the panel promises, one of the prominent topics of conversation was around what an “industrialized” cell therapy manufacturing paradigm will ideally look like in the future. As we are all wont to do in this nascent space, the speakers regularly referenced the more mature biologics manufacturing paradigm as a prime example of how far an industry can come once it becomes less hampered by trade secrets.
It was during this part of the conversation that Sophia Sharp Donaldson, executive director, supply chain, global strategic sourcing and procurement for Kite, jumped in with one of her/Kite’s biggest learnings so far on its manufacturing journey.
“We’re starting to allow partners in upstream,” she outlined. “Instead of just handing them our characterized processes and saying, ‘Here are our processes and the manufacturing equipment we need to use,’ we’re letting them in earlier so we’re both learning together how to characterize and scale those processes. I think that’s the secret sauce: to not be afraid of sharing and codeveloping your processes earlier because, at the end of the day, it’s going to help the whole industry. Once we get to a certain stage, our partners can then commercialize that manufacturing process and use the knowledge they’ve gained to benefit other CGT companies.”
I thought this was valuable advice to share because it singlehandedly addresses not one but three of the biggest themes/challenges afflicting CGT manufacturing paradigms today:
- A general lack of industry transparency over CGT manufacturing processes;
- Notable knowledge gaps accompanied by an industry-wide talent shortage; and
- Insufficient analytical characterization/understanding of cell therapies MOAs & CQAs.
Her advice also gave me pause because it stands at odds with one of the predominant narratives in the CGT space today: that “building,” as opposed to “buying,” is downright necessary for companies to “control one’s destiny,” “keep the knowledge in-house,” and “protect IP.” Those italicized words are almost medieval in their strictness; this industry is wearing impenetrable chainmail and it’s not ashamed to admit it. Obviously, there’s no one right answer to the build-vs. buy debate. But the language around keeping manufacturing to oneself is why Donaldson’s advice stood out to me as much as it did: it provided a glimpse at a much freer world — and one that emphasizes a more collaborative outsourcing paradigm to boot. The more collaborative work carried out between tech providers/suppliers, CDMOs, and innovators, the more experience and knowledge is gained and can be shared across the industry. This goes a long way to closing knowledge gaps, increasing the talent pool, and easing the industry through its current hang-ups — many of which are cell-culture-centric.
The more time I spend in this space, the more I see the industry starting to realize that many of the manufacturing unknowns it’s facing can be alleviated by greater collaboration and knowledge sharing. For example, in addition to the example Kite is setting, the FNIH’s recently announced Bespoke Gene Therapy Consortium is a fantastic indication of the industry’s gradual acceptance that not all ingredients need to be THE ingredients. When it comes to the currently “top-secret” full-empty capsid ratio in the AAV space, I argue in a recent blog post that “looser lips will hardly not sink ships.” In fact, publicizing that information more regularly may actually help the industry and regulators figure out when and if it’s necessary to draw some lines — which is what the industry so desperately needed to figure out, like, yesterday.
So, if I were to offer my two cents on what an industrialized CGT industry looks like, I would point to Donaldson’s quote/best practice as a fantastic example of where we need to go on a larger scale. An industrialized industry will have undergone a period of great self-reflection — and many long chats with IP lawyers — to figure out which pieces of the manufacturing process truly deserve to be the “secret ingredients” passed down through generations (and documented in opaque legalese), and which are just the salt and pepper, to taste.