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mRNA Webinar Series

WEBINARS

Key Benefits of PCR-based mRNA Manufacturing for Clinical Development

Session 1: May 16

To unlock the potential of your mRNA therapies and accelerate your mRNA development and manufacturing program, discover the benefits of our novel PCR-based mRNA drug substance manufacturing process. With this innovative and flexible process, we can provide mRNA at all scales and qualities for all stages of a mRNA program life cycle, from pre-clinical to commercial.

Learn about our truly integrated mRNA-LNP CDMO offering, and how we can support you as the single-source partner along all critical steps from mRNA drug substance manufacturing, through lipids and lipid nanoparticle (LNPs) to fill & finish of the final drug product.

In this webinar, you will learn:

Which key parameters impact mRNA manufacturing speed, capacities, and quality
The benefits of our flexible GMP mRNA manufacturing platform for clinical and commercial mRNA demands
How our innovative PCR-based process can accelerate your mRNA development and manufacturing program
mRNA CDMO Services as part of our highly connected network to ensure speed, scalability, quality and flexibility for mRNA, lipid, LNP formulation and Fill & Finish

Who Counts as an Expert? Establishing Analytical Methods for Emerging mRNA-based Therapies

Session 2: May 25

The success of the first vaccines for SARS-CoV-2 demonstrated both the effectiveness of mRNA technology and the speed at which new vaccines could be developed using such a platform.

The sudden emergence of this novel modality has necessitated the rapid development of analytical methodologies to ensure product quality and to meet the evolving regulatory requirements. This challenge is further complicated by the different nature of mRNA drug substance and the formulated drug product, often in the form of a lipid nanoparticle (LNP).

In this webinar, we describe the use of cutting-edge technologies to assess critical quality attributes of both mRNA drug substance and drug product.

In this webinar, we will explore:

The toolbox of methods to support mRNA products, comprising a combination of off-the-shelf assays and product-specific methods
The power of Next Generation Sequencing to detect potential issues
The deployment of GMP-compliant LC-MS to support activities from analytical development through to QC
The use of UHPLC with Charged Aerosol Detection for the analysis challenging analytes, such as mixtures of lipids in an LNP

Speakers

Julian Mochayedi, Ph.D.

MilliporeSigma

Strategic Marketing Manager for mRNA Solutions

Julian Mochayedi is the strategic marketing manager for mRNA solutions and is responsible for the strategy development and positioning of the mRNA offering based on the acquisition of AmpTec, a leading mRNA CDMO. He holds an M.Sc. in bioprocess development and a Ph.D. in translational immunology from the University of Heidelberg with expertise in the area of in vivo gene editing.

Eike Joest, Ph.D.

MilliporeSigma

Principal Scientist for mRNA Innovation

Eike is principal scientist for innovations and technologies in mRNA service offering. He was responsible for the development of the upscaled mRNA manufacturing process and implementation of AmpTec technologies in R&D. Eike holds an M.Sc. with distinction in biochemistry from Wuerzburg University and a summa cum laude Ph.D. in cellular Biochemistry from Frankfurt University.

Martin De Cecco, Ph.D.

MilliporeSigma

Technology Lead, Product Characterization

Martin De Cecco is the technology lead for product characterization at MilliporeSigma, overseeing the development of new analytical testing services. Martin has over 12 years’ experience developing methods for the characterization of novel biotherapeutics, having worked in the CRO industry and previously at a leading LC-MS vendor. He holds a Ph.D. in biophysical chemistry and an MSci degree in Forensic & Analytical Chemistry.

Amy Glekas, Ph.D.

MilliporeSigma

Global Business Lead, NGS and Novel Modalities

Amy is a global business lead, NGS and novel modalities, at MilliporeSigma. In this position, Amy drives the growth of testing business using exciting, novel methods. With over 15 years' experience working on various viral vector, mRNA and CRISPR projects, she provides technical and consultative support to organizations working with RNA vaccines and therapeutics. Amy holds a B.S. in genetics from Purdue University and a Ph.D. in biochemistry from University of Illinois at Urbana-Champaign.