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Viral Vector Manufacturing Insights to Support your CGT Program
Join this expert-led webinar for a practical look at the key challenges and strategic decisions in viral vector manufacturing for cell and gene therapies. Through concise, real-world case studies, you'll explore:
- Transitioning from adherent to suspension culture – Insights on moving from research-scale adherent production to clinical-grade suspension systems.
- Managing the "QC tax" – Strategies to reduce the impact of quality control testing on material supply.
- Comparing US vs. EU standards – Key differences in regulatory pathways for CGT product approvals.
Designed for professionals in regulatory strategy, manufacturing, and quality control, this session offers clear, actionable takeaways to help streamline and strengthen your processes.
Webinar Presenters
James Cody
Associate Director Technical Evaluations, CGT CDMO Services
Charles River
James has worked in the viral vector CDMO space since 2018 and is currently a member of Charles River's gene therapy CDMO business development team. James obtained a PhD and completed postdoctoral training in cancer gene therapy at the University of Alabama at Birmingham (UAB), studying oncolytic viruses. Afterward, he worked as a research scientist in virology, cell biology, cancer, and parasitology. Based at the viral vector manufacturing site in Rockville, MD, James provides technical support to the business development team, helping to guide client discussions and onboard new projects by collaborating with subject matter experts across various functional groups.
Megha Sharma
Site Quality Head, Viral Vector CDMO Center of Excellence
Charles River
Megha Sharma is an experienced leader in the Biopharmaceutical industry with over 15 years of expertise in Quality Control, Quality Assurance, sterile manufacturing, and regulatory, specializing in the biologics and cell and gene therapy space. Currently serving as Site Quality Head at Charles River, she has led cross-functional teams through regulatory inspections, tech transfers, and quality system implementations supporting both clinical and commercial programs. With a strong foundation in Quality Systems, Megha is passionate about building a quality culture, ensuring patient safety, and enabling the timely delivery of transformative therapies. She is also a strong advocate for continuous improvement and operational excellence within regulated environments.
Giovanna Gayosa
Manager, Process Development and Research Operations
Charles River
Giovanna is a biomedical scientist specialized in pathology and a trained biotechnologist. She has built her career across clinical diagnostics and translational medicine, where she gained extensive experience bridging research into clinical applications. Over the years at Charles River Laboratories, Giovanna has also worked in plasmid development production and currently serves as Manager of Operations in viral vector process development and research, supporting the advancement of gene therapy platforms. Enthusiastic about scientific innovation and collaboration, she is dedicated to developing processes that can bring promising therapies closer to patients.