Comprehensive chromatographic assessment of forced degraded in vitro transcribed mRNA
Heightened interest in mRNA therapeutics has accelerated the need for analytical methodologies that facilitate the production of supplies for clinical trials. This webinar will present a concise panel of chromatography-based stability-indicating assays for evaluating thermally stressed in vitro transcribed mRNA as part of a forced degradation study.
Our expert speakers will demonstrate the application of these methods to evaluate the critical quality attributes (CQAs) of mRNAs as well as to detect intrinsic process- and product-related impurities.
Key learning objectives
- Characterization of thermally stressed mRNA using a panel of chromatographic assays
- Implementation of SEC-MALS to confirm transcripts reflect full-length sequence design
- Platform 5’ cap/3’ tail analyses, circumventing antisense probe design
- Design of QC-friendly methods fit for research, release, and comparability testing
Who should attend?
- QC lab technicians or lab assistants.
- Lab managers of development, process development, or QC.
- Directors/Senior directors of development, process development or QC
- VP of Quality; VP of Development or VP of CMC.
- Anyone interested in learning more about light scattering and its applications on mRNA characterization.
- Industry and academic researchers working in gene therapy and biotherapeutics.
- Any scientist in discovery, development, and quality control.
Presenter: Jaclyn Cika (Scientist – Protein Biochemistry group, Regeneron)
Jaclyn Cika joined the Protein Biochemistry group at Regeneron Pharmaceuticals in 2019. She provides late-stage development and commercial support through the biophysical characterization of Regeneron antibody and AAV reference standards. She also oversees the qualification status of various SEC-MALS systems, and is responsible for SEC-MALS method qualification for commercial products. Additionally, she focuses on the biophysical characterization of nucleic acids, primarily using light scattering techniques, for early research and development support.
Presenter: James Greco (Regional Account Manager, Wyatt Technology, Waters | Wyatt Technology)
James Greco is a Regional Account Manager at Wyatt Technology, bringing over 16 years of experience in the biopharma industry. He has a B.Sc. in Biology from Salve Regina University. He began his career at BMS, where he spent eight years specializing in biophysical characterization. In 2017, he joined Wyatt Technology as a Field Application Scientist, where he supported and provided advanced training to customers across various fields. He later transitioned to his current role as Regional Account Manager.
Presenter: Charlie Carter (Life Sciences Editor, SelectScience)
