iSpeak Blog

Applications of mRNA Technologies

David Estapé, PhD
Applications of mRNA Technologies

mRNA is back at the 2022 ISPE Biotechnology Conference. Last year we learned from major key players about their journey to develop first time mRNA vaccines against COVID-19 and build manufacturing capacity for billions of doses in less than one year. In 2022 we are revising the relevance of mRNA technology and widening the view beyond the COVID vaccine.

Oliver Hennig, PhD
Senior Vice President Operations
BioNTech SE

Dr. Oliver Hennig, Senior Vice President of Operations at BioNTech, will present as a keynote speaker looking to manufacturing individualized mRNA-based therapies. Moreover, the BioNTainers will be presented as a manufacturing solution to democratize access to mRNA-based vaccines and therapies.

The keynote session will be followed by the “Applications of mRNA Technologies” technical session with three presentations. Aaron Allen from Moderna will revisit the platform introduction and qualification for the Spikevax™, the COVID vaccine developed by Moderna. Richard Gaynor from BioNtech will present their complementary toolkit approach of four4 drug classes, which can be combined with each other (e.g. CAR-T cell therapy combined with mRNA therapeutic vaccine) to harness the full potential of the immune system. Jasna Curak, from Global Quality & Compliance at Roche, will close the session by reviewing current ATMP-specific GMP guidance (e.g. PIC/S Annex 2A). Attendees will have the opportunity to learn about a Roche facility dedicated to individualized ATMP manufacturing and discuss different manufacturing strategies taking into account unique GMP considerations related to different product modalities (e.g. individualized mRNA therapeutic vaccines).

Session Speakers:

Jasna Curak
Global Quality and External Collaboration Manager At Roche
F. Hoffmann La Roche Ltd
Aaron Allen
Director, Global Quality
Moderna Therapeutics
Richard Gaynor, MD
BioNTech US

Juan Andres
Chief Technical Operations and Quality Officer
Moderna Inc.

Finally, Juan Andres, Chief Technical Operations and Quality Officer at Moderna, will present the closing keynote and discuss the company’s journey from start-up to scale-up, overcoming challenges, and moving into the future. Included in this presentation will be Moderna’s pre-pandemic background, COVID preparation and operations insights, executing against the plan, and the company’s future operations.

Last year we had to sit and listen the presentations in front of our computer screens. This year you have the first-time opportunity to listen and meet in person the team members from Moderna and BioNTech that make possible the mRNA vaccines. Join us in Boston for this exciting opportunity to learn, network, and enjoy the 2022 ISPE Biotechnology Conference.

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