Viral vector manufacturing: optimization through culture, QC and regulatory standards

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Viral vector manufacturing: optimization through culture, QC and regulatory standards

This webinar offers a focused, expert-led exploration of key challenges and strategic decisions in viral vector manufacturing for cell and gene therapies, structured around a series of concise, real-world case studies:

1. Transitioning from adherent to suspension culture: Gain insights into switching from research production in adherent culture and clinical-grade production in suspension.

2. Managing the “QC tax”: Strategically managing the amount of material consumed by QC tests.

3. Comparing US versus EU standards: Explore the differences between US and EU regulations regarding CGT product approvals.

Whether you're working on regulatory strategy, manufacturing design, or quality control, this webinar delivers actionable takeaways, put into context through case studies, to help you optimize your processes.

Presentations will be followed by a Q&A session, providing the opportunity to engage directly with technical and QC subject matter experts.

James Cody

Associate Director Technical Evaluations, CGT CDMO Services at 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 at 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 at 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.

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