Women in STEM: How PAT and AI Are Redefining Bioprocessing in Biologics (Part 1)

*Full transcript available below

Carrie Mason, head of Process Analytical Technologies (PAT) Center of Excellence at Lonza Integrated Biologics notes that PAT and AI now function in tandem to deliver more robust and reliable production. In an interview with BioPharm International® as part of its Women in STEM coverage, Mason explains that, by embedding advanced analytics into process control strategies, bioprocessing teams can practically aim to consistently achieve required product quality attributes and “right‑the‑first‑time” manufacturing outcomes for complex biologics.

“What we are able to do with our PAT tools is augment [them] with advanced AI technologies in order to enhance process control strategies, and those process control strategies are what allow us to meet the product quality and characteristics necessary for a good batch,” Mason says.

Instead of traditional “measure-then-decide” approaches, AI-enabled PAT systems support predictive control, Mason observes. These tools can interpret complex, evolving data streams from bioprocesses and feed them into advanced control strategies that anticipate deviations before they occur. This capability is increasingly critical as the industry grapples with more complex molecules and new therapeutic modalities, she emphasizes.

How will integrated bioprocessing shape the future of manufacturing?

Mason anticipates that the future of biologics manufacturing lies in automation and integration. Moving away from discrete, manual unit operations toward integrated bioprocessing can shorten development timelines and increase process robustness. Advanced analytics and AI, she explains, provide the insight needed to confidently connect steps, automate decisions, and accelerate scale-up.

These technologies are already being applied within Lonza’s network, for example, with the goal of advancing timelines and reaching the clinic faster. For the broader industry, Mason’s perspective underscores a pivotal shift, namely that as PAT and AI become more tightly linked, biomanufacturing is moving toward more adaptive, data-driven, and clinically responsive production models.

About the speaker

Carrie Mason, Head, Process Analytical Technologies (PAT) Center of Excellence, Lonza Integrated Biologics

Leveraging more than 25 years of industry experience, Mason leads a multidisciplinary team in the development and implementation of novel bioprocessing PAT solutions throughout the Lonza network. Prior to Lonza, she held roles at various healthcare companies, leading efforts to develop manufacturing strategies for therapeutic products. Mason is involved as a member of the National Institute for Innovation in Manufacturing Biopharmaceuticals and the BioInnovation Group, with a desire to drive forward innovations for the advancement of the biomanufacturing industry.

Transcript

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Speaker 1

Hi, I'm Carrie Mason. I'm the head of the pat Center of Excellence for Lonza within their integrated biologics network. My role here is looking at process analytical tools and technologies that we can utilize in our bio manufacturing operations. I've been in industry over 25 years. My background is a separation scientist. I have supported process development of biologics, in addition to commercial manufacturing and support of biologics throughout the Lonza network.

Pat and AI really work hand in hand in working towards developing a robust process. What we are able to do with our pa t tools is augmented with advanced AI technologies in order to enhance process control strategies. And those process control strategies are what allows us to meet the product quality and characteristics necessary for a good batch when we produce for our customers, the it has really evolved over time, and so with the addition of AI into pa t, it gives us the ability to look at our data in a much more complex and evolving way. We're able to do advanced process control strategies that allow us to incorporate predictive control, where in the past, we did a lot of traditional kind of get result and then use the tool to make a decision, whereas now, analytics are now tied to AI and allowing us to build more information and be able to get much more robust process characteristics categorized with that technology, we're able to really drive to write the first time manufacturing, which allows us to then be able to bring our processes to market faster and quicker in a much more robust manner.

So when we're looking at the future of manufacturing, automating and integrating our processes in order to remove away from individual steps is going to be critical. One of the ways that we're able to do that is by using advanced analytics and AI technologies in order to give us the information necessary to move forward. Complex molecules and new modalities are really driving our industry to be adaptive and to drive towards a methodology that's going to get us there faster. And that's where, when you're looking at integrated bioprocessing as a way of making that happen. At you know, Lonzo, we are working on multiple customer processes that allows us to use that technology in order to advance timelines and to be able to reach our clinic faster.