mRNA vaccines rapidly gained the spotlight during recent years as a result of the COVID-19 pandemic and their quick implementation in response to SARS-CoV2 virus. The core molecular technologies of these therapeutics have been in development for decades in various forms and are now following breakthroughs that overcame some of the initial challenges, moving rapidly from R&D benchtops to GMP clinical development and front-line patient treatment.
As such, quality systems, compliance principles, process controls and analytics must keep pace and adapt to this new class of therapeutics. While production of mRNA therapeutics shares many of the key quality considerations as established for other larger molecule therapies, the methods of production and determination of key quality attributes are still emerging and are specific to the new technologies and evolving in step with research and technological advances in the field.
This webinar will provide a general overview of mRNA therapeutics design and production and discuss the importance of robust quality systems in the context of GMP production of mRNA therapeutics. The speaker will focus control of raw materials used in production, identification of appropriate quality control testing methods for release and stability and analytical method development specific to the production and evaluation of bulk mRNA drug substance or intermediate.
Join today for a review of the quality concepts in the development of mRNA vaccines, especially in the context of GMP IVT mRNA development, manufacturing and analytics.
Lisa Alexander, MS, MBA, Vice President, Quality Operations for R&D and Biologics, Curia Global, Inc.
Lisa Alexander is the VP of Quality Operations for R&D and Biologics at Curia with oversight of multiple sites across the globe. She has over 30 years of experience in quality and GMP manufacturing of regulated biologics and diagnostics for the United States, European Union, Canada and ROW. She has supported the development of novel biologics and diagnostic products from research through to commercialization in the US and European markets, with leadership roles at organizations including CDMOs as well as small companies and global corporations, including Amgen, Millipore, GE Healthcare (Xcellerex), Brammer Bio and LakePharma.
Douglas Demian, Site Quality Head, Curia Global, Inc.
Douglas Demian is the Site Quality Head of the Curia Hopkinton MA site, which specializes in clinical development and production of biologics including mAbs, proteins and mRNA. Doug has over 20 years of pharma and CRO experience in early discovery research, CRO operations, analytical and quality leadership. He has broad experience in small and large molecule early discovery as well as GMP analytics for large molecules. Doug’s past experience includes Pfizer, Inc., Blue Sky BioServices and LakePharma, Inc.
Who Should Attend?
STEM students, manufacturing, research and quality professionals interested in understanding the current quality and analytical practices and considerations for development and production of IVT mRNA drugs for human therapeutic use.
What You Will Learn
Attendees will learn about:
- Basics of mRNA therapeutics, relative benefits and challenges
- How mRNA-based therapeutics offer promising patient outcomes and quality risk profiles with fast, cost effective production, but manufacturing and analytical method controls are still evolving
- General principles and concepts around quality oversight and analytics applied to development and manufacturing of mRNA therapeutics
- How regulatory guidance is changing the quality and analytical landscape for mRNA therapeutics
Curia is a Contract Research, Development and Manufacturing Organization with over 30 years of experience, an integrated network of 29 global sites and over 3,500 employees partnering with customers to make treatments broadly accessible to patients. Our biologics and small molecule offering spans discovery through commercialization, with integrated regulatory and analytical capabilities. Our scientific and process experts and state-of-the-art facilities deliver best-in-class experience across drug substance and drug product manufacturing. From curiosity to cure, we deliver every step to accelerate and sustain life-changing therapeutics. To learn more visit us at curiaglobal.com.