How A Sponsored CMC Platform Accelerates mRNA Projects Into The Clinic

The processes to develop messenger RNA (mRNA) treatments and advance them into clinic and eventual GMP manufacturing can be complex. Partnering with a CDMO eases the burden on the developer to build, test and implement processes and shortens the timeline for the drug product's development. Workflows and processes such as post template linearization, Target Product Profiles (TPP), and Analytical Target Profiles (ATP) are critical to the development process, but need improvements to create further efficiencies and meet the needs of varying mRNA projects.

In this Webinar, Jon Cooper, Ph.D., the Senior Director of RNA Sciences and Analytical Development at Aldevron, discusses the benefits of developing both a client-sponsored TPP and ATP as part of a drug's comprehensive development plan. To move a drug product to clinic and eventual GMP processes, it is critical for the client to help define these target profiles to develop custom assays and manufacturing operation processes optimized for the drug product's needs. Efficiently advancing a project to clinic requires advanced, robust processes to mitigate safety risks and ensure product quality. Integrating an ATP which changes over time in response to improvements in methodologies and evolving regulatory expectations ensures the product meets quality and safety standards and helps move the project to clinic efficiently. Learn more about the optimized analytical method lifecycle and fit for purpose platform approach that can maximize the potential success of your drug.

A Q&A session follows the presentation.