How AI-Driven Batch Review May Reduce Biomanufacturing Labor Burden

Advances in automation and artificial intelligence (AI) are reshaping manufacturing strategies for cell and gene therapies (CGTs), according to Alan K. Smith, PhD, executive director, Global Scientific Portfolio Management, Cell and Gene Therapy, Charles River Laboratories, in an interview with BioPharm International®coming off of INTERPHEX 2026, which ran April 21–23 in New York City. Dr. Smith highlights how emerging automated and semi-automated systems are being designed specifically to support complex therapeutic processes, offering more standardized and streamlined approaches to production.

While current systems are not yet universally compatible with all CGT processes, ongoing technological development is expected to improve alignment between platform capabilities and manufacturing needs, Dr. Smith explains. These “plug-and-play” systems aim to reduce variability and increase efficiency, particularly as therapies progress from development to commercialization.

A key area of transformation that Dr. Smith notes is the integration of AI and machine learning into operational workflows. He explains that these technologies may increasingly handle routine tasks traditionally performed by humans, including batch record review. By applying a “review by exception” model, AI systems can monitor process parameters and flag deviations that fall outside predefined ranges, allowing human experts to focus on critical decision-making.

How can AI and automation improve efficiency in CGT manufacturing?

The adoption of automation and AI is expected to reduce labor demands while improving consistency in manufacturing processes, Dr. Smith says. He emphasizes, however, that human oversight will remain essential, particularly for final review and quality assurance functions.

“I think we recognize there's a patient at the end of every one of these processes, and we need to be sure that we're doing the best we can for those patients,” Dr. Smith states.

In addition to automation, early and proactive planning was identified as a critical success factor. Aligning process development with future commercial requirements, while leveraging available digital tools, may help organizations avoid costly delays and redesigns.

As regulatory approvals for advanced therapies continue to increase, Dr. Smith expresses optimism that automation, AI integration, and forward-looking manufacturing strategies will support the continued growth and accessibility of life-altering and potentially curative treatments.

View more from Dr. Smith in this interview.

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About the speaker

Alan K. Smith, PhD, Executive Director, Global Scientific Portfolio Management, Cell and Gene Therapy, Charles River Laboratories

Dr. Smith has more than 40 years of experience in the cell therapy and gene therapy field with experience in a wide variety of cell types and viral vector platforms. He has extensive experience in research, process development, good manufacturing practice (GMP) manufacturing, quality control, quality assurance, analytical assay development, GMP facilities design, construction and operation, and GMP supply chain/procurement. He most recently served as chief technology officer (CTO) of Ambys Medicines, and before that as CTO at Akouos and was executive vice president, Technical Operations, at Bellicum Pharmaceuticals, among many other previous roles. Dr. Smith holds a Bachelor of Science in chemistry from Southern Utah University and a PhD in biochemistry from Utah State University.