Gene therapy is reshaping modern medicine, offering the potential for lasting, even curative treatments for a wide range of indications. However, realizing this promise at scale remains one of the industry’s greatest challenges. Viral vector manufacturing continues to face significant bottlenecks in scalability, cost, consistency and global supply.
This webinar will explore the critical hurdles associated with scaling viral vector production from early-stage development to commercial manufacturing. Attendees will gain insights into key challenges across upstream and downstream development processes and analytical considerations.
Beyond the technical workflows, the featured speaker will highlight the broader industry challenges, including the high cost of goods, evolving regulatory expectations and the complexities of tech transfers. These factors collectively impact the accessibility and commercial viability of gene therapies.
To highlight these concepts, the webinar will feature two real-world case studies: one focused on AAV scale-up to 2,000 L and the other on implementing a platform approach for scale-up activities. These examples demonstrate practice strategies to improve process robustness, increase yields and reduce costs.
Register for this webinar to learn how viral vector manufacturing strategies can improve scale-up, reduce risk and support commercial gene therapy supply.
Speaker
Emigdio Reyes, PhD, Director of Upstream Process Development, FUJIFILM Biotechnologies
Emigdio Reyes is a self-driven, versatile Scientist and leader. He holds a PhD in Biochemistry from New Mexico State University and completed his postdoctoral work at the University of Pennsylvania and the Children’s Hospital of Philadelphia. During his postdoctoral training, he focused on virus-host cell interactions and trained in viral vector production, reinforcing his appreciation for the therapeutic potential of viral vectors. He pursued a career in viral gene therapy manufacturing by joining the Process Development team at FUJIFILM Biotechnologies’ Texas facility. Over the past nine years, Emigdio has held multiple roles within FUJIFILM Biotechnologies, broadening his expertise in viral vector manufacturing, spanning method development and validation, process development, scale-up and characterization, through to manufacturing. Presently, Emigdio leads the Upstream Process Development team at FUJIFILM Biotechnologies Texas, leveraging his multidisciplinary experience to help partners establish robust manufacturable processes for their cell & gene products.
Who Should Attend?
This webinar will appeal to:
- Biotechnology and pharmaceutical company employees involved in the development of viral vectors for cell & gene therapies
- Heads of Manufacturing, CMC, MSAT, QA/QC, Tech Ops and Regulatory professionals
- Developers/Consultants involved in development and tech transfers
What You Will Learn
Attendee will:
- Identify key bottlenecks in scaling viral vector manufacturing
- Understand practical insights to improve scalability
- Evaluate industry-wide challenges and solutions
- Apply real-world insights from case studies
Xtalks Partner
Fujifilm Biotechnologies
FUJIFILM Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines and advanced therapies. With over 30 years of experience, the Company specializes in developing and manufacturing biopharmaceuticals using microbial, mammalian, and host/virus systems. With over 4,800 employees, FUJIFILM Biotechnologies operates a fully integrated, kojoX™ global network with major facilities in the United States, the United Kingdom, and Denmark, with a new site in Holly Springs, North Carolina, USA. The Company’s kojoX™ manufacturing network ensures supply chain agility for its customers through modular facilities and standardized processes for seamless scaling and technology transfers. FUJIFILM Biotechnologies offers comprehensive services, ranging from proprietary cell line development, to process and analytical development, and through to clinical and commercial manufacturing.
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