Applying an HPLC analytical platform for mRNA process monitoring

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

Applying an HPLC analytical platform for mRNA process monitoring

In the production of mRNA, starting from plasmid DNA, it is essential to monitor and control every stage of the manufacturing process by identifying key components and contaminants. The PATfix™ HPLC analytical system, developed for monitoring the mRNA production process, is a key platform on the pathway delivering drug substances from R&D development to the production process in a rapid and efficient way. Pre-developed and validated HPLC analytical methods using different column chemistries enable:- Effective control over linear plasmid upstream and downstream,

IVT reaction optimization for mRNA synthesis
Control of yield, purity and downstream process of mRNA
mRNA formulation and stability analysis
Scale-up optimization

In this webinar, the PATfix™ HPLC platform, and its specific methods for pDNA and mRNA analytics that enable efficient monitoring of key upstream and downstream process steps will be showcased:

Efficient tracking of contaminants through plasmid downstream and linearization process
Monitoring of key component of IVT reaction (nucleotides, linear plasmid, capping reagents, mRNA)
mRNA downstream process monitoring in terms of recoveries and purity
Analytical method for control of final mRNA formulation and mRNA stability assay.

Nejc Pavlin

Project Manager in Process Analytics Development at BIA Separations

Nejc is a Project Manager in Process Analytics Development department at BIA Separations, a Sartorius Company. He has extensive experience in analytics development of different biological molecules such as pDNA, mRNA, Adeno-associated viruses, all widely used in modern therapeutics. He manages several projects for various biotech clients, mainly in the field of new generation gene therapy products. He holds a PhD in Chemistry from the University of Ljubljana, Slovenia.