Enabling and advancing mRNA-LNP medicines from concept to clinic

Sponsor

Nucleic acids (e.g., siRNA, mRNA, and saRNA) can be designed and formulated to silence, express, and edit specific genes providing a flexible and powerful approach to preventing and treating diseases. The recent commercialization and widespread distribution of COVID-19 mRNA vaccines has exemplified the massive potential to rapidly develop and scale-up new genomic medicines to protect from emerging viral threats and treat a wide range of serious diseases with unmet medical needs.

This webinar will discuss key insights and experiences that leverage modular microfluidic platform technologies and analytics to enable rapid development, testing, and scale-up of mRNA-LNP vaccines and therapeutics:

Examples from our internal R&D work to demonstrate the versatility of the genetic medicine toolbox for the rapid development of RNA-LNP Vaccines
Key considerations during development of mRNA-LNP medicines and how a comprehensive understanding of Critical Quality Attributes (CQAs) and Key process parameters are critical in developing mRNA-LNP that meet the target product profile
Challenges associated with mRNA-LNP analytical development and impact on biological activity
How Precision NanoSystems employs a panel of over 25 specific assays to de-risk LNP development programs and expedite the path to the clinic

Lloyd Jeffs, PhD

Senior Director, Biopharma Services, Precision NanoSystems Inc

Dr. Lloyd Jeffs joined Precision NanoSystems (PNI) in June 2018. His Biopharma Services team is responsible for developing and executing custom programs to meet the clinical manufacturing needs of PNI’s clients. Lloyd is an expert in developing lipid-based nanotherapeutics and has over 20 years of experience in this field, including formulation and process development, scale-up and technology transfer.

Dr. Jeffs received his PhD. in Applied Microbiology from the University of Saskatchewan and has B.Sc. and M.Sc. degrees from the University of British Columbia. He is a co-author of numerous peer-reviewed publications dealing with the development of lipid nanoparticle therapeutics and is a co-inventor for key patents in this field.

Adam Crowe, PhD

Manager, Analytical Development, Precision NanoSystems Inc

Adam Crowe manages a multi-discipline team at Precision NanoSystems Inc (PNI) tasked with developing novel analytical assays related to Lipid NanoParticle (LNP) and Nanomaterials for drug delivery. During his tenure, Adam has garnered broad expertise over the 50+ unique LNP compositions manufactured at PNI in analyzing particle payloads, excipients (such as lipids), physiochemical characteristics and in vitro potency. Notably, Adam and his team have increasingly leveraged cutting-edge technologies, such as LC-MS approaches, to tackle the complexities of LNP characterization. Additionally, Adam is the Technical Lead for ASTM’s guide document on analytical methodologies for RNA LNPs- a comprehensive document drafted by leaders in industry, academia, and regulatory bodies outlining best analytical practices for the LNP field.

Jagbir Singh, PhD

Director of Pre-Clinical Development, Precision NanoSystems Inc

Dr. Jagbir Singh has 15 years of research experience and, has completed >150 projects in formulation development and manufacturing process scale-up. At PNI, Dr Singh leads a team of scientists and staff to develop a diverse range of formulations including mRNA, pDNA, siRNA, peptides and small molecules. Dr. Singh received his Ph.D. from University of Saskatchewan and completed postdoctoral training from BC Cancer Agency. He is a recipient of 2014/15 Canadian Breast Cancer Foundation and 2015-2017 Michael Smith Foundation Postdoctoral Fellowships. His work has been published in numerous publications and has received 2012 Gattefossé Canada/CSPS Award in Lipid-Based Drug Delivery. He is a co-inventor on two patent applications.

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