On The Ground At NextGen Biomed 2026

At this year’s NextGen Biomed, a conference on biologics research and development hosted by Oxford Global, Bioprocess Online’s chief editor, Tyler Menichiello, had the chance to connect with Tiffany D. Rau, Ph.D., a CMC consultant and adjunct professor of biochemistry and cell biology at the University College Cork in Ireland.

The following transcript has been edited for clarity and readability.

You gave a talk today on cell line development. What do you hope the audience took away from that talk?

Rau: I hope that the audience got the idea that we need to start integrating our processes earlier — from cell line development all the way to purification and formulation — and making sure that we're using all of our knowledge to build our data sets. We should also make sure that we're utilizing historical data, the latest predictive modeling, and building robust experimentation earlier so that we can actually help de-risk the process development and scale-up starting in cell line development.

It's really key that we're working in tandem. It's not just, “I'm working on cell line development,” and then I go, "Oh, let's throw it over the fence." It really is a collaboration, and we want to make sure that we have the right tools. So, my talk was about how to integrate organizations and make sure that we are developing processes that are representative and predictive and ready for the future. I don't just want to know what happened in the past — that's great information, but I want to leverage that past information to predict the future. I want to make sure that the cell lines and upstream and downstream processes are able to be transferred to manufacturing and actually end up as a product for the patient one day.

What aspects of cell line development and/or process development do you wish you could have told the audience?

Rau: One of the things I wish I could have gone more into is how we're implementing modern design of experiments — where we're able to gain more information with less experiments — and being able to show people that. I was able to give a small example of how we compare clones, but I wasn't able to go into just the amount of data and knowledge that we get from using new designs of experiments. We really want to make sure that we're designing for success and making sure that we are looking into the regulations as well, because we want to make sure that it is compliant, and doing that earlier rather than later builds success for us.

What has been your favorite session at NextGen Biomed? What is the coolest thing you’ve seen or learned since being here?

Rau: I think the coolest part is that there are so many people with varied backgrounds. There are people who do discovery work; there are people in manufacturing. Of course, I'm working from early stage all the way to commercial manufacturing — I also work with teams on facility design, building, and start-up, so being able to interact with a ton of different people has been really invigorating. We all speak the same language, as we're speaking English at the conference, but we're all doing different things. Seeing how the antibody is actually engineered and designed gives perspective to potential opportunities and challenges as it is transitioned into cell line development and  scale-up. So, I think that's really one of the great parts of this, as well as interacting with our vendors, because each of them has a lot of new technology and is thinking, “Hmm, how do we implement that?” Or “Maybe I won't implement it right now, but I'll save it for another day.”

What do you hope people took away from our bioprocessing fireside chat?

Rau: I'm hoping that they took away the fact that we need to plan and understand where we're going with our molecules. We don't have all the answers, but we should be making sure that we're building the robustness and understanding what our limitations are in the molecules and how we're producing them so we're not surprised later on. I think that's one of the important things.

We need every group. Our academic groups, that are very much working on the cutting edge — we need to be able to also have cutting edge  in our industry and be able to balance it. I hope that the audience got a taste of the fact that it's not trivial to bring something through the CMC pathway, but we have a plan. And with planning and risk assessments, it's really key, because we want to make data-based decisions as we go along. Sometimes the decisions we're making are difficult, but it's key to be able to continue, document, and understand.

Also, cross-pollinating between our manufacturing teams and our discovery teams, and really valuing our people, I think that's really key. We can have a great molecule, but if we don't have the people to go on that journey with us, whether they're internal or external to our projects, they're all part of the process.

What is one piece of advice you'd like to impart to our audience?

Rau: Never stop asking questions and enjoying what you do! And the fact is, our patients are waiting. Those patients may be human health patients, they may be veterinarian patients, or you might be in the food industry as well — with some of the new cultured cheeses and other things — so the important thing is to continue to ask questions, innovate, and enjoy yourself. That's the important part.