CRISPR-Cas shows promise in leveraging nonclinical and manufacturing information from one disease indication to another, potentially without repeating redundant, costly, and time-consuming nonclinical studies. That’s the driving message in a webinar that featured a pioneer in human genome editing, Dr. Fyodor Urnov, Scientific Director at the Innovative Genomics Institute (IGI).
The manufacture and release of mRNA therapeutics and vaccines is a complex and challenging process requiring a high degree of expertise, capabilities, and experience. The development and manufacturing of final drug product involves several stages that include production of cell banks, linear DNA, and mRNA drug substance, with lipid nanoparticle (LNP) formulation/encapsulation and analytical testing at all steps, through aseptic fill/finish.
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.
The manufacture and release of mRNA therapeutics and vaccines is a complex and challenging process that requires a high degree of expertise, capabilities, and experience. The production process involves several stages, including the production of cell banks, linear DNA, mRNA drug substance, LNP encapsulation, fill/finish, and analytical testing at each step. Each production stage must be executed with extreme care to ensure the final product's safety and efficacy.
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.
Collaboration has always been an important part of scientific research and discovery, especially when you combine the resources of strategic partners in science, clinical, engineering and manufacturing.
BIO International’s annual convention is one of the largest gatherings of biotechnology innovators in the world. The Aldevron team attending this year’s in-person gathering in San Diego observed that the past few years of COVID restrictions haven’t changed the high interest in our industry.
We often hear how interest in, and use of, RNA technology is growing because of the COVID-19 pandemic. One discussion at the TIDES USA conference had a unique perspective: how Moore’s Law may now apply to RNA technology.
Managing the H1N1 outbreak in 2009 was considered a practice run for the recent SARS-CoV2 pandemic and, over the last two years, we certainly learned a great deal in being prepared for the next virus to gain a foothold. That was the backdrop as we returned to the World Vaccine Congress in Washington, DC.
