Cell Therapy
Cell-Based IO
Gene Therapy
Raw Materials
Scaling Up

Continuous Innovation for Manufacturing Raw Materials at Scale

15 March 2021

An interview with Sean Kevlahan, ph.d., senior director of cell & gene therapy at Bio-Techne

Q: How does a push for innovation dovetail with the rest of the industry…and how is it specific to Bio-Techne?

A: From an industry point-of-view, I think of the importance of Quality by Design (QbD): ensuring that quality needs and considerations are systematically built into every stage of the process. This means you never innovate just for innovation’s sake. Specific to us, well, continuous innovation is a constant internal push for us. We’re, to my mind, the ideal size: big enough to scale up with our customers and small enough to be nimble. That innate ability is central to our process.

Q: How typical is it for you to use that agility and adapt to a particular customer need?

A: It’s the ideal scenario. Tailoring our product to a customer’s process isn’t an unexpected lift for us; it’s our norm. Internally, we emphasise having the ability to tune our products, formats and concentrations because doing so nearly always meets a business need. Flexibility and customisation have an excellent ROI in cell and gene because the better a match your raw materials are to your process, the less risk you experience in manufacturing.

Q: Since cell and gene is a young field, is it accurate to assume that scalability needs are still on the road ahead for most customers, right?

A: Yes. As more and more therapies work their way through clinical trials scalability becomes top of mind. When we partner with a customer we always work towards meeting the terminal scale (the heaviest lift, the biggest supply need) for that particular therapy. I believe we should be several steps ahead of the next scale milestone for any particular therapy. If our customer is planning ahead, that’s fantastic and we are here to partner with them as they plan. If they are enmeshed in the needs of a current stage, we’ll be out in front, clearing the way for future phases, end goals, and the ultimate patient population.

Q: How does something more mundane, like supply agreements, factor into the process of innovation?

A: With a supply agreement comes that guarantee of continuity of supply, whether in clinical or commercial phases. And to get there, we assign a dedicated team (quality, regulatory, product management, commercial) to answer questions, address issues, be the direct, always-available line to the customer. Having an open two-way line of communication means that ideas and needs and best-case scenarios are all part of the conversation. It helps identify pain points and nice-to-haves, both of which are a natural fit for a QbD mindset.

Q: How do the pain points translate to an innovation?

A: We have to be an inch wide and a mile deep in our customer’s pain points because a full understanding of their experience in manufacturing a therapy is critical. Again, you never innovate in a vacuum. You innovate as a direct reaction to building an improvement into the process.

Q: To what degree are customers integral to this process?

A: It completely depends on the customer’s needs. Some want to be a part of the innovation process and some want to be able to get the best fit off the shelf. If we have a deep relationship with a customer, that tends to organically evolve into a back-and-forth of ideas. But it’s not a requirement, by any stretch. Regardless, customer feedback is invaluable. It keeps us in tune with the space and ensures that new and existing products are going to resonate.

Q: Do you have a central concept around which all of this revolves?

A: My mantra is that it’s about what fits the design. Most pain points are ultimately a case of a solution being a mismatch to the design model, right?, so we are always looking to that design model and making sure we’re hewing to it more and more precisely. You identify the nuances of any given problem and then you find the most elegant solution. Everything comes down to a robust and consistent process and matching the design mantra via our customer requirements is what moves the needle.

Find out more about Bio-Techne and their case for achieving ancillary/raw material consistency and flexibility of deliverability for manufacturing partnerships at scale in their latest eBook.

Text link: https://www.phacilitate.co.uk/article/raw-materials-scale-success-factors-commercial-cell-and-gene-therapy-manufacturing