Eike Joest
Principal Scientist at Merck Life Science KGaADr. Eike Joest is Principal Scientist for innovations and technologies in mRNA service offering. He was responsible for development of the upscaled mRNA manufacturing process and implementation of AmpTec™ technologies in R&D. Before joining Merck Life Science KGaA in Darmstadt, Germany, he demonstrated broad technical expertise in synthetic biology and molecular biology by publishing in several peer-reviewed journals. Eike holds a M.Sc. with distinction in Biochemistry from Wuerzburg University and a summa cum laude Ph.D. in cellular Biochemistry from Frankfurt University.
All Sessions by Dr. Eike Joest
Title: Enhanced mRNA performance by PCR-based manufacturing
As a versatile platform, mRNA represents a promising tool for upcoming therapies. To ensure clinical success, robust mRNA drug substance manufacturing is essential throughout all project stages. The corresponding manufacturing processes need to guarantee fast, harmonized, and scalable production while maintaining the same high-quality standards. In parallel, resilient raw material supply determines manufacturing speed and capacities. We have developed a scalable mRNA manufacturing process based on polymerase chain reaction (PCR). We compared the impact of both, plasmid based (conventional) and our PCR based manufacturing strategies within head-to-head comparison case studies. To ensure an accurate comparison, we standardized all other process parameters. Subsequently, we performed a comprehensive analysis of product quality attributes. The generated mRNAs exhibited significant differences in poly(A)-tail distribution and dsRNA levels. These quality differences were further reflected by mRNA performance, both in cellulo and in vivo. Overall, the present case studies emphasize the importance of scalable manufacturing and further highlights the impact of manufacturing strategies on mRNA quality and performance.
Summary:
- Scalable and robust manufacturing is essential to guarantee all phases of mRNA therapeutics
- To overcome the limitations of conventional processes, we developed a scalable PCR-based strategy
- Within a case study, we contrast the performance of conventional and PCR-based mRNA manufacturing