FUJIFILM Biosciences’ Brandon Pence on Autologous Cell Variability, Viral Vector Capsid Quality, and the Path to Scalable CGT Manufacturing

Sitting down with BioPharm International® at the 2026 BIO International Convention (BIO 2026) last June, Brandon Pence, president and chief operating officer of FUJIFILM Biosciences, discusses the most persistent manufacturing challenges facing cell and gene therapy (CGT) developers, with a particular focus on cell consistency in autologous therapies and capsid fill quality in viral vector-based gene therapies.

Pence identifies cell consistency as the central challenge in regenerative medicine manufacturing. In autologous therapies, the patient is the source of the cells used to manufacture the therapy, meaning patient health status and biological variability are directly embedded in the starting material, he explains. Companies such as FUJIFILM Biosciences are working with developers and patient advocacy groups. The goal is to design cell culture systems that reduce this variability and enable more effective scale-up and scale-out of manufacturing processes, he notes.

Why does CGT manufacturing still lack an established platform comparable to traditional biologics?

Pence attributes the absence of a standardized CGT manufacturing platform to the simultaneous development of multiple distinct therapy types, such as autologous versus allogeneic and ex vivo versus in vivo. Each carries different process requirements, he specifies. Additional unresolved hurdles include automation gaps, chain of custody assurance, and consistent output quality. He says substantial development work remains to be done across all of these dimensions.

On gene therapy specifically, Pence identifies capsid fill ratio as a persistent industry-wide challenge. Producing viral vectors with consistently full capsids and reliably removing empty and semi-full capsids that do not carry the intended genetic payload remains technically unsolved at scale, he explains.

"Until we can really consistently get over that hurdle, I think that will always be something that pulls us back from a gene therapy manufacturing perspective," Pence states.

He notes that cell culture process quality directly influences capsid production quality and that purification strategies for separating empty from full capsids require continued development.

BIO 2026 occurred June 22–25 in San Diego.

To explore more of our conference coverage, click here.

About the speaker

Brandon Pence, President and Chief Operating Officer, FUJIFILM Biosciences

Pence joined FUJIFILM Biosciences in his current role in 2024. He has direct oversight of teams in global manufacturing and quality, finance, R&D, human resources, and all commercial operations for the business. Prior to joining FUJIFILM Biosciences, he was vice president of Business Development and Strategy at Avantor Sciences and has held vice president/general manager positions at Thermo Fisher Scientific leading a variety of businesses including Cell Biology, Purification, and Pharma Analytics. Prior to that, Pence led market development and strategy for GE Healthcare’s bioprocessing division (now known as Cytiva). Pence is a graduate of Utah State University and started his career as a scientist working in the development of cell culture processes for mammalian and insect cells prior to moving into business-focused roles.