Streamlining development, ensuring quality and safety
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.
Focusing on workflows and what processes need to be included, Cooper discusses items from post template linearization to target product profiles (TPP) and analytical target profiles (ATP). While these elements of the development process are essential, there are methods to improve the speed in which they are implemented.
Platform versus Proposal
Of particular importance in faster development is a CMC platform. This approach taken by a CDMO such as Aldevron can reduce the number of steps and increase efficiency as compared to a process that a developer has to build, test and implement. Cooper walks through the different approaches, showing where the efficiencies are built into the process and how they benefit clients.
Cooper also discusses the additional steps in the process that includes RNA transcript and process design/optimization, along with purification strategies. A highlighted point is the ATP, which actually drives the entire analytical method validation process and can be used throughout the analytical method lifecycle. He points out that the ATP is a living document that can change over time as processes improve or regulations are updated.
He also takes into account the technology transfer process, describing the process workflow, including where information needs to be exchanged for the development process to operate efficiently. This wraps into standard assay panels, with a commitment to continuous improvement and extension.
The primary questions from the webinar sought further information about the considerations for an analytical testing panel for an mRNA drug project. Cooper expanded on the dependencies regarding trial sizes and the type of project, with the key quality attributes are one of the main considerations, along with the project experience of the developer.
During the Q&A portion of the webinar Cooper was joined by Bo Chung, Director of Regulatory Affairs/Compliance at Aldevron. There was some discussion on technology transfer concerning what documentation should be prepared as the project is initiated, with the key being to understand the TPP and be aligned with regulatory agencies, early and often.
Furthermore, at the mRNA Analytical Development Summit, excitement surrounded the comprehensive set of tools provide by Aldevron in an analytical panel package following the USP standard guidelines, but also the ability to customize the assay list based on customer’s needs.
To get complete information, be sure to watch the webinar, and submit any questions you may have to Jon Cooper and Bo Chung for review.
- Contact Jon Cooper and Bo Chung with questions
- Visit Aldevron’s RNA platform web page
- Have an idea for a follow up? Let us know