Scaling DNA & Large RNA Construct Production, Analytics and Quality Control to Develop Regulatory-Ready mRNA Vaccines, Therapeutics and Cell and Gene Therapies
As the mRNA field evolves beyond vaccines into diverse modalities, delivery systems, and therapeutic areas, mastering evolving CMC and process requirements is more important than ever. With regulatory scrutiny on CMC packages and new draft guidelines emerging from the EMA, the call for robust, high quality, quick and cost effective methods is monumental.
mRNA pipelines are maturing, but complexity continues to grow - from dsRNA impurities and manufacturing automation, to scaling for GMP readiness and stability. As the field faces increasing regulatory expectations and new modalities like circular and self-amplifying RNA enter the clinic, the industry must redefine what process excellence looks like.
The 4th mRNA Process Development & CMC Summit has united the Process, CMC, Manufacturing and Regulatory leaders driving this transformation to build a new standard for mRNA production and compliance.
The event provided a great opportunity to meet and discuss mRNA process development and share experiences and generate data to fill in knowledge gaps that will help with understanding the technology platform.
Michael Anyadiegwu, CMC Innovations & Technology Lead, CEPI
The event provided a great opportunity to meet and discuss mRNA process development and share experiences and generate data to fill in knowledge gaps that will help with understanding the technology platform.
Markus Bergmann, Global Head of Personalised Cancer Vaccines, CureVac
I appreciated the opportunity to engage with experts globally. The collaborative atmosphere and the openness of participants to share challenges and solutions created a dynamic and inspiring environment.
Rita Correro, Chief Technology Office, Inofea AG
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