Guten tag from Berlin! As an analytically minded-person, it’s fascinating to connect with colleagues from around the world to discuss cutting-edge techniques and strategies for ensuring the quality, efficacy, and safety of mRNA-based therapeutics. That fascination led me to the mRNA Analytical Development Summit, held in Germany's capital city.
Analytical testing is a critical factor in the development of mRNA-based therapeutics, while at the same time presenting significant challenges. Pre-clinical and clinical testing are only part of what needs to be included in the development process, with the need to meet regulatory requirements while competing in the marketplace being additional considerations.
When discussing mRNA development, the complexity across a variety of modalities can give pause to how the projects should be approached and developed. With that in mind, Jon Cooper, Ph.D., Senior Director of RNA Sciences & Analytical Development recently presented, How a Sponsored CMC Platform Accelerates mRNA Projects into the Clinic, in this webinar and recently at the mRNA Analytical Development Summit in Boston, to provide an outline of an effective development process.
From the early days of therapeutics development, a common refrain has been that GMP manufacturing takes longer and costs more than expected. This can be traced back to when programs often started in academic laboratories, which then needed substantial analytical and process development as a program moved towards clinical stages.
Rapid evolution. In short, that’s what we’re seeing in the method development and assay life cycle field. The concepts have been around for quite some time, but now with updated and new guidance for analytical life cycle and analytical method development, we’re seeing a more dynamic period emerging in the space. This includes increased expectations for analytical method development and increased accountability for reporting development data.
