mRNA Vaccines
Analytical Strategies for mRNA Therapeutics and Vaccines Messenger RNA (mRNA) therapeutics and vaccines represent a groundbreaking advancement in modern medicine.
Ensuring their quality, safety, and efficacy requires rigorous analytical methods focused on Critical Quality Attributes (CQAs) such as:
- mRNA integrity
- Purity
- Capping efficiency
- Residual impurities
To characterize and quantify these CQAs, chromatographic techniques play a central role, including:
- Ion-pair reverse-phase HPLC (IP-RP-HPLC)
- Size-exclusion chromatography (SEC)
- Ion-exchange chromatography (IEX)
- MS Technology
Sarita and Catalin explore the importance of defining and monitoring critical quality attributes (CQAs) and outline analytical strategies for mRNA characterization and impurity profiling. Sarita emphasizes the value of reference materials in method development, bridging, and assay performance monitoring to ensure process consistency and reliability. Catalin will exemplify the use of mass spectrometry to iterate it's ability to create critical quality attributes.
Key learning objectives:
- Gain an overall understanding of Critical Quality Attributes for messenger RNA
- Discover the current analytical strategies for creating critical quality attributes. for mRNA thru chromatography and Mass Spectrometry.
Who should attend:
- Analytical Scientist and chemists involved in Method Development, Validation, and Quality Control of mRNA products. Biopharmaceutical and Biotechnology Professionals. Regulatory Affairs Specialists. Process Development Scientists.
Presenter: Sarita Kattel, M.S. (Principal Scientist, Global Biologics, US Pharmacopeia)
Sarita Kattel serves as a Principal Scientist in USP’s Global Biologics Department. At USP, she utilizes her extensive vaccine experience to advance the development of standards supporting vaccine manufacturing. Her role also includes creating new standards for analytical testing of oligonucleotide products and exploring additional opportunities for standards in various other areas.
Ms. Kattel’s career spans over biotech companies, academic institutions, contract research organizations (CROs), and pharmaceutical giants like GlaxoSmithKline (GSK) and Janssen Pharmaceuticals. She has held lab-based roles in method development and validation, Chemistry, Manufacturing, and Controls (CMC) leads, as well as quality control, working on monoclonal antibodies, proteins, and mRNA-based vaccines.
Presenter: Catalin Doneanu PhD. (Principal Scientist, Waters Corporation)
Catalin Doneanu received his Ph.D. in analytical chemistry from Oregon State University in 2002. After a postdoctoral stage in the Department of Medicinal Chemistry at University of Washington in Seattle, he joined Waters Corporation in 2006. He is currently a principal scientist in the Biopharmaceutical Sciences group. He has more than twenty years of experience in separation sciences and mass spectrometry. His current research interests are in the area of therapeutic oligonucleotides and protein characterization using LC-MS. Catalin has over 30 peer-reviewed publications.
Moderated by: Samuel Seal (Biopharma Market Development Manager, Waters Corporation)
Samuel Seal is a market development manager specializing in the biologics space. He loves LC and MS – especially on how this technology provides benefit and value.
Sam joined Waters in January of 2014 as a Sales Technical Support Specialist in the Irvine office/lab. As a TSS he performed demonstrations on various instruments, provided training for customers, often presented on technical information at varying events, and assisted with troubleshooting from Colorado to Los Angeles.
He previously worked at Pyxant Labs in Colorado Springs, CO where he gained extensive experience developing and validating methods for small/large molecules in bioanalytical assays, agricultural commodities, registration of pesticides, and worker exposure studies. He also has experience in column chromatography, sample extraction, sample clean-up, reporting and data management. Sam has hands on experience with running and maintaining various manufacturers' LC/MS/MS systems. Prior to Pyxant, Sam was a Laboratory Instructor at the University of Colorado at Colorado Springs where he earned his Bachelor of Arts in Biology and Bachelor of Arts in Chemistry.
