Why Early Process Design Is Key to Cell and Gene Therapy Success

From the panel discussion, “Future-Ready Biomanufacturing: Insights from GMP Leaders,” at INTERPHEX 2026, occurring in New York City on April 21–23, Alan K. Smith, PhD, executive director, Global Scientific Portfolio Management, Cell and Gene Therapy, Charles River Laboratories, emphasizes the importance of early-stage manufacturing strategy in an interview with BioPharm International®.

Calling on his more-than-40 years of experience spanning gene-modified cell therapies, viral vectors, and plasmids, Dr. Smith highlights recurring gaps in how emerging therapies transition from development to commercialization.

According to Dr. Smith, companies developing advanced therapeutic products often prioritize speed to first-in-human studies, sometimes at the expense of long-term manufacturing readiness. While early clinical milestones are critical, insufficient attention to scalable processes and robust systems can create downstream challenges during later-stage trials and commercial production, he explains.

He notes that failing to anticipate scale-up requirements or commercial demand may result in the need to redesign processes, leading to delays and increased costs. This issue is particularly relevant in the rapidly evolving cell and gene therapy (CGT) sector, where manufacturing complexity and regulatory expectations continue to increase.

Why is early manufacturing planning critical for CGT scale-up?

A key recommendation Dr. Smith offers is, “Begin with the end in mind.” He notes the importance of ensuring that process development aligns with eventual commercial manufacturing needs. This development includes designing systems that can support increased production volumes and adapting to potential market demand if therapies achieve regulatory approval.

Within the contract development and manufacturing organization (CDMO) environment, Dr. Smith explains that flexibility is essential to support multiple clients with varying process requirements. Facilities must be designed to accommodate different manufacturing platforms while maintaining compliance with good manufacturing practice (GMP) standards. Modular infrastructure and adaptable equipment can help CDMOs scale capacity efficiently as client programs advance.

Dr. Smith adds that integrating scalability and flexibility into early development decisions can reduce the need for rework and better position therapies for successful commercialization, particularly in a competitive and resource-intensive field like CGTs.

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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.