Home » Vol. 40(2) - March / April 2022 » Why validation is key to the industrialization of cell and gene therapies
Vol. 40 | Vol. 40(2) - March / April 2022 | CELL & GENE THERAPY

Why validation is key to the industrialization of cell and gene therapies

by cyb2025
S. Wall, S. Ahmed

STEVEN WALL*1, SHARIF AHMED2
*Corresponding author
1. BioPhorum, London, United Kingdom
2. Bayer U.S. LLC Pharmaceuticals, United States

ABSTRACT

A particular challenge associated with commercializing a cell and gene therapy (CGT) product is defining and performing a successful process and product validation campaign. This is particularly challenging due to limited experience, data and guidance currently available for CGT products. BioPhorum’s CGT validation workstream have published an article highlighting these issues, showcasing a number of unique validation challenges, and potential solutions, associated with CGT validation. Here we speak with one of the lead authors, Sharif Ahmed of Bayer, who kindly highlights some of these challenges, key takeaways/recommendations from the team, and the benefits of working as a cross-industry collaboration to discuss and identify potential solutions to common challenges.

Cell and gene therapy (CGT) products are a class of advanced therapeutics with tremendous potential in treating diseases. However, the challenges in manufacturing them are complex and industry is working to develop commercial capabilities, standard platforms, and sufficient capacities to address a growing pipeline. Successful commercialization of CGT products requires a multi-disciplinary approach that fully integrates patient needs and product knowledge with the capability to commercially manufacture these complex products consistently and reliably.

ABOUT THE AUTHOR

Steven Wall is a scientific facilitator with over 20+ years’ experience within industry and academia. He gained his PhD in Cell & Molecular Biology from the University of East Anglia, followed by post-doctoral research at the University of Southern California. Steven then spent over 10 years working in industry before joining BioPhorum in the Cell & Gene Therapy Phorum.

Sharif Ahmed is an accomplished biotech leader with 10+ years of experience in successfully leading process validation activities for therapeutic proteins, antibodies and gene therapy manufacturing platforms. He obtained a PhD in Genetics at Michigan State University, prior to post-doctoral work at the University of California-Berkeley. Sharif currently serves as Senior Product Supply Product Lead for rFVIII products at Bayer Pharmaceuticals.

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