BPI现场专访：Tatyana Matveeva博士谈分布式生产模式

By Tyler Menichiello, Chief Editor, Bioprocess Online

If you listen to the Better Biopharma podcast, you may be familiar with Tatyana Matveeva, Ph.D., an expert in regulatory compliance and cGMP manufacturing who recently joined me to discuss quality unit independence in biomanufacturing.

We spoke at length about the importance of quality control in bioprocessing and the operational consequences of treating quality as a consideration rather than a guiding principle.

I recently caught up with Matveeva at BioProcess International (BPI), where she participated in a panel discussion with several experts titled “Decentralized Manufacturing in Cell Therapy: Overcoming Implementation Challenges and Enhancing Patient-Centric Solutions.”

Though I wasn’t able to attend her session, we discussed the panel and her thoughts on distributed manufacturing, as well as her experience at the conference.

The following transcript has been edited for clarity and readability.

You're speaking on a panel Friday. What’s that session about and what do you hope the audience takes away from it?

Matveeva: We'll be covering topics on decentralized manufacturing, which is a very hot topic in cell and gene therapies (CGT) right now, as well as in general biologics. There's a lot to consider. There are huge benefits to decentralized models, but they're also not problem-free. There are risks to quality that have to be carefully considered, as well as risks to coherent compliance. It addresses some manufacturing aspects, but not other logistics around manufacturing or therapy administration. So, we'll talk about some of those logistical complexities, regulatory complexities, and how different therapeutic modalities really lend themselves to this sort of distributed manufacturing model.

So far into BPI, what sessions or tracks have you been attending? What’s resonating, and what themes are you picking up on?

Matveeva: This year, I really wanted to focus on AI applications in biomanufacturing, which is a hot topic. There is a lot to learn, a lot to understand. And, as we know, regulatorily, things are complicated with AI. Quality applications are complicated. We're still sort of in the infancy of understanding where and how to really apply AI well so it can enhance decision-making.

It's a very interesting topic. There are multiple takes. We do deep dives on which areas of which phase of a process could be favorable, as well as the constraints that need to be considered. So, I focus primarily on AI in biotech and biomanufacturing, and hopefully, I’ll leave with some great takeaways to bring to my work.

Aside from being here to speak, what else are you here for? What do you hope to get out of the conference?

Matveeva: It's been great to meet with a lot of colleagues. Nowadays, a lot of collaboration happens all across the network, be that in consultancies, different aspects of quality oversight, regulatory, or CGT innovation. So, to see everyone physically, face-to-face and all at once, and be able to have productive conversations, attend talks, and discuss next steps in collaborative processes I think is the best part.

Some time has passed since we recorded our podcast episode. Has anything occurred to you in that time that you wish this came up during our conversation on centering quality in cGMP manufacturing?

Matveeva: There’s always so much to talk about when it comes to quality, and generally, GMP is something that never really ends. It's always a work in progress. If you have quality by design (QbD), you are still constantly improving and evaluating risk.

One of the things that I was recently thinking about, especially for early-phase quality oversight, is how to accommodate the production of different modalities or different therapeutics within the same system and still ensure quality oversight. Maybe that's something we can discuss in the future.

Any last thing you’d like to leave our audience with?

Matveeva: Come to BPI! It's really fantastic; it’s a great place to meet and collaborate with people, learn a lot, and get your eye on some of the great innovations going on all across manufacturing.