On the latest episode of the science talk show GEN Live, I was joined by a pair of experts to discuss the state of bioprocessing. On the show, titled “What’s Tipping the Scale for Bioprocessing?”, and co-hosted by John Sterling, GEN‘s Editor in Chief, Susan Abu-Absi, PhD, and Stephen Sofen, PhD, shared their perspectives on bioprocessing’s big challenges, the role that automation and AI will play in the future, and the innovations driving the field forward. They also shared what they are looking forward to at the BPI meeting next week.
Abu-Absi has over 20 years of experience in biologics and cell and gene therapy process development and manufacturing. She most recently served as CTO at 2seventy bio. Sofen was, most recently, CTO at Abata Therapeutics and also has over two decades of experience in technical innovation, product development, and manufacturing alliance management and strategy.
After we discussed the trends in cell and gene therapy, automation, quality control, how cell therapy companies are scaling up manufacturing, how the role of CDMOs are evolving, and what impact AI will have in transforming cell and gene therapy manufacturing, we turned the conversation to the upcoming Bioprocess International meeting in Boston next week.
Here is what Abu-Absi and Sofen are looking forward to at BPI 2024 and their predictions for the future of bioprocessing.
Abu-Absi: One of the things that I love about BPI is the mix of high-level, strategic, keynote discussions and highly technical tracks. I like that mix of visionary—where are we going in the future—versus diving deep into the technology.
So, I’m pretty excited. The FDA is going to be there to discuss the biotechnology and biomanufacturing initiative, which is going to be cool.
I’d love to hear some lessons learned, and I think Vertex is going to be there talking about the launch of their sickle cell product—the first cell therapy engineered by CRISPR to be commercialized.
There is also a lot of new stuff coming up. Bispecifics are not completely new, but there are a lot of advances there. Also, immunocytokines, extracellular vesicles, siRNA, and nucleic acid medicines. All of the cutting-edge, new stuff, will be mixed in with what I think are some really timely lessons learned and recent examples.
And then the other benefit at BPI is the networking, getting to meet people face to face, and the sidebar conversations that happen afterwards.
It has shaped up to be a really good event!
Sofen: One of the things conferences like next week’s offer, and Susan alluded to it, is that I constantly worry about the CDMO gestalt, or the environment around CDMOs. They must overbook early-stage programs (because many will fail) and hope that just the right number get to commercial status. They must invest in advance with commercial capacity. They run on significantly lower margins than fully integrated innovator companies, and so they can’t, almost by definition, invest in fundamentally new technology because they need to get a return. And their clients, who are often small, start-up biotechs, run away from any sort of royalties.
They clearly serve an invaluable clientele. If every company that started off in cell and gene therapy built their own facilities, then we clearly would have a huge glut of capacity, much of which would be sub-optimal. And so, I kind of worry. On the one hand, we’ve had a lot of consolidation in cell and gene therapy CDMOs. On the other hand, you want them to be able to be nimble, to be responsive. It’s an interesting niche in the overall biotech universe.
LeMieux: I’m going to ask you to pull out your crystal balls and ask you what will be some of the biggest changes in bioprocessing five or 10 years from now?
Abu-Absi: We hit on a lot of it today, in our discussion. I think AI is going to be revolutionary. I think this ongoing standardization is going to happen. I’m really intrigued by the role of CDMOs in cell and gene therapy because, if you recall, the first innovator companies that launched CAR T therapies manufactured in-house. They built their own manufacturing facilities. The amount of money out there was different than it is today. So now these small start-up biotechs really must partner with CDMOs.
They need that CMC organization that a CDMO brings. And I think that could drive some really rapid learnings. And if we do it right, that standardization and then joint advancement. So, I think there are some technologies out there that we can’t even really imagine that will make manufacturing easier. And maybe make a more potent product.
Sofen: I don’t really have anything more to add. We have already in this hour talked about a lot of the things we’re hoping show up soon: automation, machine learning, artificial intelligence. And not so artificial intelligence (chuckling).
Sterling: Bioprocess 4.0 (digitization and automation) which a lot of companies, especially big pharma, have still not totally accepted. But, in the November issue of GEN, we talk about Bioprocess 5.0. And there are going to be some differences between the two.
I’m not going to give it away now; I want the audience to read it. But a hint is that there is going to be more focus from companies on what they are actually doing for the patient. Everybody says that: over the past 40 years, I’ve heard everybody say patient, patient, patient. And that ethos has probably always been there, but it’s going to be highlighted in Bioprocess 5.0.
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