Karen Walker, CTO of early-stage cell therapy manufacturer Kyverna, spoke at a future of flexible manufacturing panel at the American Biomanufacturing Summit last month. Here she talks to GEN about why cell therapy manufacturing needs to be agile.
What’s important about flexible manufacturing?
Walker: Technological advances in the gene and cell therapy business are so fast that the platforms that Gilead and Novartis developed for the first CAR T are already obsolete. So, flexible manufacturing isn’t just about facilities, it’s also about technology, talent, and data working seamlessly and staying agile to keep up.
How are you using flexible manufacturing technologies at Kyverna?
Walker: We’re an early-stage company and have work to do before our products are commercial and can help patients. We’re not sure what the technology platforms will be in the future, as their footprint has halved in the last six years, so we need to stay vigilant to identify and incorporate new advances.
What are the design and construction considerations that improve success?
Walker: Even with an allogeneic platform, with cell and gene therapies, you’re making a patient-specific product. Batches are small, the footprint is small, and the QC lab is as big as the production facilities. As technology turnover time is about three years, we’re looking at open-concept clean rooms, which accommodate the equipment necessary to manufacture our products. Then we can focus on versioning them up.
We’re also focused on talent. Our industry has huge potential to be impactful but is still in its infancy. Hiring people with experience in cell and gene therapy who can also envisage what the future looks like is like looking for unicorns. So, as well as people with experience, we’re also hiring people with transferrable skills, and people early in their career.
What other aspects of flexible manufacturing do you see as important?
Walker: In the cell therapy literature, there’s lots of evidence that cells cultured in vitro for nine-to-10 days differentiate into different cell types and lose their potency. We don’t want to leave the power of our product in the bioreactor, so we’re looking to use younger and less differentiated cells.
What’s the outlook, in your view, for flexible manufacturing technologies in cell therapies?
Walker: Many buzzwords in other industries, such as agile, blockchain, and big data are going to influence what flexible manufacturing will be like in our industry. Manufacturing is going to look different to how we’ve viewed it over the last fifty years.