Process and analytical insights for GMP manufacturing of mRNA lipid nanoparticles

Sponsor

The successful development and rapid deployment of the messenger RNA (mRNA) vaccines against SARS-CoV-2 virus has catalyzed the industry to look more closely at the technology beyond its potential use for novel vaccines to enable breakthrough treatments for cancer, rare diseases, and more. However, the absence of standardized protocols means manufacturers must develop and optimize their process, leading to a considerable number of variables and decisions throughout the production workflow.

This webinar will discuss key insights into the potential of the mRNA and lipid nanoparticle (LNP) technologies that underpin the COVID-19 vaccines, barriers to successful industrialized manufacture of mRNA–LNPs, and approaches to optimizing process development and manufacturing. The panel will address:

The 5 steps of manufacturing mRNA-LNP drug products, including DNA template manufacturing, mRNA drug substance synthesis and purification, mRNA–LNP formulation and purification, fill/finish operations, and analytical testing
Process and analytical considerations for GMP manufacturing of mRNA-LNPs
Challenges and opportunities for mRNA-LNP therapeutic development

Emmanuelle Cameau

Gene Therapy Strategic Technology Partnership Leader EMEA, Pall Corporation

Emmanuelle has more than 15 years’ experience in Biotechnology Process Development and GMP production. Highly skilled in the field of cell culture applications, Emmanuelle joined Pall Biotech more than 10 years ago first as a Bioprocess Specialist (BPS) for 4 years. She then transitioned to the Bioreactor Applications team, where she was Principal Bioreactor Specialist until March 2021 when she joined the newly formed Gene Therapy business unit as Strategic Technology Partnership Leader. Prior to Pall, Emmanuelle worked as a Biotech Process Sciences Upstream Process Development Engineer at Merck Serono for 4 years. She received her Biotechnology Engineer diploma from the former Ecole Supérieure d’Ingénieurs de Luminy (now Polytech Marseille).

Peiqing Zhang

Gene Therapy Strategic Technology Partnership Leader APAC, Pall Corporation

Peiqing Zhang is the Strategic Technology Partnership Leader Gene Therapy at Pall Corporation, responsible for technical engagement with customers and the gene therapy community across Asia Pacific. Peiqing has more than 15 years of experience in biotech research, development, and commercial manufacturing. Prior to joining Pall, he held various roles with increasing responsibilities in technical transfer and manufacturing science and technology, at Novartis, and analytical science and CMC management at Transcenta. Before moving to the biopharmaceutical industry, he was with A*STAR-Singapore’s Bioprocessing Technology Institute and was an Adjunct Assistant Professor at National University of Singapore (NUS). He has published more than 20 peer-reviewed papers in biology and biotechnology. Peiqing obtained his PhD from NUS.

Shell Ip

Client Learning & Scientific Content Manager, Precision NanoSystems

Shell Ip is the Client Learning and Scientific Content Manager at Precision NanoSystems. He has been serving in technical communication and training roles in Precision NanoSystems' commercial team since 2015. He combines his multidisciplinary background with an aptitude for communication to convey complex concepts to diverse audiences through various media. In his postdoctoral and doctoral research, he developed hybrid bio/inorganic nanomaterials for diagnostics applications. He has earned a Ph.D. in Chemistry and a B.A.Sc. in Engineering Science from the University of Toronto.

Linda Mathiasson

Strategic Customer Lead, Nucleic Acid Therapeutics, Cytiva

Linda Mathiasson is the Strategic Customer Lead in Cytiva's Nucleic Acid Therapeutics business unit, responsible for technical and scientific engagement and collaborations with customers in the global RNA application community. Linda has more than 22 years of experience in the Life Sciences industry and since she joined Cytiva in 2009 has held numerous roles in R&D, focusing on product development and customer collaborations to support biotech research, process development and GMP manufacturing. For the last two years Linda has been working as Strategy Manager for Cytiva's initiatives in the area of mRNA therapies/vaccines and small scale GMP solutions.

Katarina Stenklo

Enterprise Commercial Activation & End-to-end Solutions Leader, Cytiva

Katarina Stenklo is an experienced biopharma professional with over 19 years of industry experience. She currently works for Cytiva in the Enterprise Solutions business unit. Katarina knows how important it is to have a holistic view of the manufacture of biomolecules. She has extensive expertise in developing end-to-end manufacturing solutions that includes process workflows, process equipment, automation, consumables and facilities. Her main focus over the last few years has been developing and designing solutions for the manufacture of new product modalities such as viral vectors, plasmids and mRNA therapies.