Strategies for Advancing Clinical and Commercial Manufacturing of mRNA Therapeutics
Connect with Industry Experts at the Virtual PNI Symposium
Join us on July 19th for the Precision NanoSystems' Symposium, a virtual event exploring the evolving manufacturing landscape of genomic medicines. This live event features industry leaders who will share strategic insights for navigating the challenges and opportunities for clinical and commercial production of mRNA therapeutics.
This series of panel discussions and presentations is free to attend.
Date: Wednesday, July 19
Time: 8:00am-11:00am PT | 11:00am-2:00pm ET | 5:00pm-8:00pm CET
Keynote Panel Discussion: Clinical and Commercial Manufacturing of mRNA Therapeutics: Opportunities and Challenges
Presentation: Standardizing Scale-up: Insights into Producing Clinical and Commercial RNA-LNP Drug
Products
Panel Discussion: Maximizing Yield and Purity in RNA-LNP Downstream Processing
Register now to save the date!
Clinical and Commercial Manufacturing of mRNA Therapeutics: Opportunities and Challenges
8:00am PT | 11:00am ET | 5:00pm CET
The emergence of COVID-19 led to the rapid progression and commercial validation of mRNA vaccines and the lipid nanoparticle (LNP) technology underpinning this new drug modality. However, the industry
still faces significant challenges navigating the evolving manufacturing and regulatory landscape. This interactive panel discussion will address:
- Manufacturing strategies to expand LNP delivery to new applications such as cancer vaccines and personalized medicine
- How decreasing scale will impact the processes and workflows of biopharma manufacturers
- Regulatory
considerations for each development phase to improve efficiency and safety
Moderator: Dr. Martin Rabel
Senior Field Application Scientist
Precision NanoSystems
Panelist: Dr. Jeff Atkinson
Executive Director of Process Development and Analytical Science
Omega Therapeutics
Panelist: Dr. Angela Johnson
Global Regulatory and Compliance Leader
Cytiva
Panelist: Dr. Lloyd Jeffs
Senior Director of BioPharma Services
Precision NanoSystems
Panelist: Sujit Jain
Director, External Manufacturing
SalioGen Therapeutics
9:00am PT | 12:00pm ET | 6:00pm CET
Speaker: Dr. Ian Villamagna, Senior Field Application Scientist, Precision NanoSystems
Over the last few years, there was an unprecedented demand on biopharma manufacturers to produce an mRNA vaccine in an accelerated timeline. Given the considerable number of variables throughout the production workflow, new flexible and robust manufacturing solutions are required to accelerate scale-up and standardize GMP manufacturing processes.
This presentation will share:
- Insights into new platform technologies that increase efficiency to enable rapid scale-up and large-scale manufacturing of mRNA vaccines and therapeutics
- How to improve operational flexibility by expanding single-use technology to LNPs
- Strategies to increase manufacturing capacity during clinical and commercial production
10:00am PT | 1:00pm ET | 7:00pm CET
Downstream processing of RNA-LNPs can often be a bottleneck during scale-up to clinical production. Maximizing yield and purity is a key concern along with controlling critical process parameters. This
panel discussion will examine tangential flow filtration (TFF), an essential step in post-formulation purification of RNA-LNPs, including:
- The essential steps for designing and optimizing downstream processing of RNA-LNPs
- Challenges with scaling TFF processes and controlling key parameters such as filtration cartridge, membrane material and transmembrane pressure
- Strategies to achieve high flux and throughput while maintaining critical quality attributes including size, morphology and yield
Moderator: Dr. Shell Ip
Client Learning & Scientific Content Manager
Precision NanoSystems
Panelist: Jon Petrone
Senior Director, Technical Consultancy
Cytiva
Panelist: Dr. Pierrot Harvie
Clinical Manufacturing Manager
Precision NanoSystems
Panelist: Dr. Emily Port
Principal Scientist in Nanopharmaceutical Formulation
CPI
Panelist: Dr. Cameron Webb
Senior Scientist
Lonza