2025 Cell Therapy Outlook From BPI West

By Tyler Menichiello, contributing editor

While at this year’s BioProcess International U.S. West (BPI West), I regrettably couldn’t make it to many cell-therapy-specific sessions. However, I was able to catch up with Takeda’s head of process and product development for cell therapies, Amy Shaw, after her talk “Addressing the Challenges in Allogenic Cell Therapy Manufacturing.” I asked for her thoughts on the cell therapy space in 2025 and beyond, as well as her biggest takeaways from the conference.

Below is a transcript of our brief conversation in San Diego (edited slightly for clarity and readability). You can read more about her presentation in my conference recap. While you’re at it, feel free to watch this executive roundtable discussion from earlier this year to compare the panelists’ industry outlooks to Shaw’s.

What is the main message you wanted to convey in your talk today?

What I think is important to come out of the talk today is really planning with the end in mind. We’re looking at addressing some of the difficulties that we experience in manufacturing for allogeneic processes and really trying to create an understanding of the limitations of CMC. We want to instill that mindset into our research colleagues early on to create expectations that reflect true manufacturability outcomes. We’re also incorporating automation as much as possible early on, which allows for smoother scaling into commercial and later stages without having to do nearly as much comparability.

I'm curious to hear your biggest takeaways from the conference. What have you been hearing this week, and what are you excited about?

I think it's been an interesting week! We started out with a little bit of a reality check on where we are in terms of the market and with maybe a decrease in excitement around cell therapies, despite how transformative we know them all to be. But overall, I just really enjoyed the commitment to creating things that actually can get to patients through the mindset of, “How can we incorporate some of these new tools like AI and machine learning (ML) and leverage them to better our therapies going forward?”

Looking forward into 2025 and beyond, what are you looking forward to the most? What are you most excited about innovation wise?

I'm hopeful that we can get more therapies approved so we can better understand what things are really driving patient outcomes. It'll be an interesting next couple of years. A big topic at JP Morgan this year was China. I think people are really trying to take these therapies into China and see, “Can we expedite some of the clinical readouts there?” So, that will help us get more patient data to understand again, what is important? What should our CQAs be for these cell therapies? And as ML becomes more and more of a reality, how can we use all of the data that we're creating in the most powerful way so that we can optimize these therapies?