AI, Automation, and Early Planning Help Shape the Future of Advanced Therapy Manufacturing: a Q&A with Dr. Alan K. Smith

In an interview with BioPharm International®, Alan K. Smith, PhD, executive director, Global Scientific Portfolio Management, Cell and Gene Therapy, Charles River Laboratories discusses manufacturing scalability, operational flexibility, and automation trends shaping the cell and gene therapy (CGT) sector. Dr. Smith outlines how biopharmaceutical developers can better prepare manufacturing processes for commercial success and addresses the growing role of artificial intelligence (AI) and modular manufacturing systems in supporting advanced therapeutic development. CGTs continue to expand commercially and clinically, he notes, with FDA reporting a growing number of approved products and ongoing regulatory efforts to support innovation in the sector.^1,2

BioPharm: How can biopharma companies scale up CGT production more quickly to meet growing demand?

(Dr. Smith, Charles River Laboratories): There are some key things I would suggest companies developing these types of advanced therapeutic products consider. I would highly suggest beginning with the end in mind. Oftentimes, there is a rush to get to first-in-human [studies] and to treat those first patients, and, in so doing, companies sometimes miss the mark in terms of ensuring that their process and systems are in place to pass the test at later-stage clinical trials and at commercial scale. As a result, they often have to redo things. Not thinking about the commercial end means they often do not consider how they are going to handle scale-up and meet demand if they are commercially successful.

What are the most effective strategies for building flexibility into modern biomanufacturing operations?

In the CDMO [contract development and manufacturing organization] space, we are trying to meet the needs of multiple clients, and so we have specifically designed our facilities and capabilities to be somewhat client-agnostic but very flexible in terms of being able to provide adequate, controlled environments for manufacturing under good manufacturing practice. Ultimately, that flexibility means that when a client does need to scale, we have an ability to, in a modular fashion, actually build additional capacity and capability into the facilities and equipment available for their processes to be successfully completed.³

What current trends in the contract manufacturing space are helping the industry improve production efficiency?

There are a number of systems coming along that are automated or semi-automated and have been designed specifically with a cell or gene therapy process in mind. Those systems are a little more plug-and-play. We are not quite at the point where every process can fit within a particular system's capabilities, but as technology advances, I think we will see more of a hand-in-glove fit with the capabilities of these equipment systems.⁴

I am also convinced that AI and machine learning will play a significant role as we advance these systems.⁵ That will provide relief in terms of labor components—a computer will be able to do batch record review using a review-by-exception approach [for example]. As long as process parameters fall within prescribed ranges, the system proceeds. If something falls outside range, it is flagged for human review. Human oversight and final review will always be necessary, but some of the detail work will be handled by AI.

Based on your panel discussion at INTERPHEX 2026, what is the take-home message for stakeholders in the next-generation therapeutics space?

Plan early and often, with an eye toward commercial capabilities. Use tools that are available, and will be available in the near term, to automate processes, reduce labor costs, and deploy AI for certain tasks. We must also recognize there is a patient at the end of every one of these processes. These are life-saving or life-altering therapies with a massive impact on patients, families, and caregivers.⁶

With some of these therapies being curative, it is vitally critical that we move these processes through the clinical and regulatory pathway to approvals. I am excited about where we are today; we are seeing numerous approvals per year, and I think we will see an acceleration of that.⁶ This is a very exciting time for this industry.

References

1. FDA. Cellular & Gene Therapy Products. Updated Jan. 11, 2026. Accessed May 22, 2026. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products
2. Druckman M, Fadahunsi Y. FDA increasing efforts to support CTGT product development. Hogan Lovells. May 21, 2024. Accessed May 22, 2026. https://www.hoganlovells.com/en/publications/fda-increasing-efforts-to-support-ctgt-product-development
3. Precedence Research. Gene Therapy Market Size, Share and Trends 2025 to 2034. Updated Nov. 17, 2025. Accessed May 22, 2026. https://www.precedenceresearch.com/gene-therapy-market
4. Panjwani S, Wei H, Mason J. Artificial intelligence and machine learning-assisted digital applications for biopharmaceutical manufacturing. Biotechnol. Prog. 2026;42(2):e70089. doi:10.1002/btpr.70089
5. Auclair JR, Joung J, Singh MA, Debauve G, Singh R. Artificial Intelligence and the transformation of cell and gene therapy development. Pharmaceutics. 2026;18(3):356. doi:10.3390/pharmaceutics18030356
6. Wonnacott K, Sojan C, Hun-Dorris T, Bates K, Shetty S. Accelerated approval as the new "norm" in gene therapy for rare diseases. DIA Global Forum. Published May 2025. Accessed May 22, 2026. https://globalforum.diaglobal.org/issue/may-2025/accelerated-approval-as-the-new-norm-in-gene-therapy-for-rare-diseases/