Addressing stability challenges of mRNA-lipid nanoparticle therapies with formulation development
mRNA-lipid nanoparticle (mRNA-LNP) technology has made an enormous impact on human health with its success in COVID-19 vaccines. It is poised to have a sustained impact on vaccines, cancer therapy and genomic medicine in the coming decades. While mRNA-LNP products hold immense potential, one current constraint is their insufficient stability, rendering them suboptimal for pharmaceutical applications. In particular, RNA integrity is a key limiting factor causing the need for deep-freeze storage. However, LNPs can suffer from attribute changes during the freezing process. Formulations with improved stability, e.g. refrigerated products with long-term stability, are highly desirable and can increase product competitiveness. To achieve that, formulation development and stability-indicating analytical tools are critical.
This webinar will outline strategies to develop mRNA-LNP formulations with improved stability and the deployment of analytical tools including capillary gel electrophoresis (CGE) with the BioPhase 8800 system (SCIEX) to support this effort. Approaches to stabilize LNPs against freeze-thaw processes and to improve mRNA stability against thermal stress will be covered. There will also be discussions about unique considerations when optimizing CGE methods for mRNA analysis and the development of fit-for-purpose methods for rapid analysis of mRNA from LNPs.
Attend this webinar to:
- Learn about the unique challenges and potential solutions in stabilizing mRNA-LNP products
- Discover how to facilitate formulation development studies of novel modalities by leveraging analytical tools, including CGE
- Explore factors to monitor when considering rapid CGE method development for mRNA-LNPs
Who may this interest?
- Researchers developing mRNA-LNP products
- Researchers working in vaccine development
Panelist
Jingtao Zhang, PhD
Scientific Director
Catalent Pharma Solutions (NJ, USA)
Jingtao Zhang is currently the Scientific Director in the Biologics Group at Catalent Pharma Solutions. He serves as a technical advisor for the group and is responsible for developing new technical capabilities and product solutions to solve clients’ pharmaceutical problems. His current focus is developing and expanding development and manufacturing capabilities in mRNA-LNP modalities within Catalent. He has more than 16 years of experience in Pharma/CDMO, discovering and developing small molecule, peptide, oligonucleotide/siRNA, biologics, mRNA and LNP drug products. His expertise is in formulation development, protein stability, new modalities (mRNA, siRNA, peptides) and complex drug delivery systems such as LNPs.
Daniel Turner
Associate Scientist
Catalent Bloomington Development Center (NJ, USA)
Daniel Turner is an Associate Scientist at the Catalent Bloomington Development Center, where he focuses on biologics formulation development. Daniel has gained experience in analytical and formulation development through the support of numerous client projects. Here he has optimized separation assays such as SEC, cIEF, and CGE needed for the characterization of protein therapeutics. Most recently he has been supporting LNP formulation development and optimizing CGE methods for mRNA-LNP purity quantification. Daniel obtained his B.S. in Biology with a minor in Chemistry from Indiana University.
In association with
This webinar was recorded on the 25th October 2023