Dr. Andrew Lewis, Chief Scientific Officer, Contributes to The Medicine Maker's "How Speed, Scale, and Science Can Personalize the Pandemic Response".
Decades of research have made mRNA a platform for fast, flexible therapeutic innovation, but its promise depends on partnerships.
To improve or accelerate clinical development, mRNA therapies leverage synthetic messenger RNA to instruct cells to produce specific proteins, and thus offer a versatile platform for treating a wide range of diseases. RNA is synthesized by in vitro transcription (IVT) from a DNA template encoding the sequence of interest, including untranslated regions (UTRs) – sections of messenger RNA (mRNA) that are transcribed but not translated into a protein. The quality of the mRNA (e.g. target sequence, length, and purity) is a key determinant of translation efficiency, stability, and immunogenicity.
All these factors impact the safety and efficacy of the mRNA-based therapeutic. It is essential, therefore, to work with partners with the experience and capabilities to optimize IVT and purification steps to maximize both mRNA yield and quality.
CPI and Quotient Sciences have formed a joint venture to integrate capabilities for end-to-end mRNA manufacturing. This shared expertise helps develop, manufacture, and perform QC testing and characterization of both mRNA drug substance and bulk formulated lipid nanoparticles (LNPs) in a single site. Such approaches ensure that the knowledge built during development is at hand as a program moves into GMP production.
Read Dr. Lewis' full article here on The Medicine Maker's site to hear more about what drives successful partnerships and a collaborative approach in the mRNA market.