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Viral vector manufacturing: Navigating complexities, finding solutions

Key takeaways:

Understand key challenges in viral vector manufacturing for cell and gene therapies
Discover strategies to overcome manufacturing hurdles
Learn how contract manufacturing partnerships can support your cell and gene program

Cell and gene therapies offer revolutionary approaches in medicine, utilizing genetic material to treat or cure diseases. This webinar will explore the promise and potential of these therapies.

We'll delve into the key challenges you may face in viral vector manufacturing, particularly for adeno-associated viruses (AAVs) and lentiviral vectors (LVs). Our discussion will cover the complexities of scaling for commercial manufacturing, the need for specialized infrastructure and trained personnel, and, supply chain challenges.

The webinar will conclude with an interactive Q&A session, addressing your questions on important aspects of viral vector manufacturing and strategic partnerships.

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Kristopher Kelly

Director, Manufacturing Science & Technology, Gene Therapy, Durham, US, Novartis

Kris is Director of Manufacturing Science & Technology at Novartis’s state-of-the-art gene therapy manufacturing facility in North Carolina, US. He has been working in gene therapies for Novartis for the last 5 years, including supporting Novartis’ clinical pipeline and launch of Zolgensma® (Onasemnogene abeparvovec) and Novartis Vaccines' first commercial cell culture flu vaccine facility. Kris has over 25 years of industry experience in facility expansions and product launches for solid dose, metered inhalers, and in-vitro diagnostics.

Tina Ivančič

Production Lead, VIFA One, Mengeš, Slovenia, Novartis

Tina is Production Lead at Novartis’ viral vector production facility in Slovenia. She joined Novartis in 2012 and has more than 10 years of experience in analytics and manufacturing, including but not limited to drug product analytics, environmental monitoring, low bioburden and aseptic production. Tina received her bachelor‘s degree in Microbiology and PhD in Biotechnology from the University of Ljubljana, Slovenia.

Sonja Prpar Mihevc

Project Lead in Quality Control, Bioanalytics, Mengeš, Slovenia, Novartis

Sonja is project lead of the Novartis Quality Control Bioanalytics laboratory in Slovenia. Sonja has experience in GMP quality control testing of antibodies and advanced therapy medicinal products (ATMPs), and she is currently leading the EU release testing of Zolgensma® (Onasemnogene abeparvovec). Her PhD and postdoc studies focused on cellular biology, adult stem cells, and neurodegenerative diseases.

Stuart Macnab

Associate Director, Manufacturing Science & Technology, Cell Therapy, Morris Plains, US, Novartis

Stuart is Associate Director of Manufacturing Science & Technology at Novartis' flagship cell processing operation in New Jersey, US. Stuart has valuable experience in GMP quality control operations having worked as both a service provider and lead for the commercial acceleration of Kymriah® (Tisagenlecleucel) – the first ever FDA approved CAR-T cell therapy. Stuart has had multiple tenures in technical research and development focused on analytical method development and contract manufacturing organization (CMO) oversite. His PhD and postdoc studies focused on molecular virology and gene therapy applications.

moderator

Surani Fernando

Healthcare journalist, writer & podcaster

Surani Fernando is a seasoned healthcare journalist and editor with over 13 years experience covering the biopharma industry. A Sydney native, she started her investigative journalism career in London covering clinical trials, M&A and financing deals for BioPharm Insight, later moving to New York to continue her work as an enterprise journalist and editorial leader for GlobalData and Reorg. She is now based in Madrid working as a freelance journalist, consultant writer and podcast producer. In November 2023, she launched the Raising Biotech podcast.