10.30.24 -- A "Flight Plan" For Achieving These 3 mRNA Development Milestones

Here, in the final installment of this three-part series, I’ll share the panelists’ greatest learning experiences and regulatory advice (so far) on what we should be looking out for as we strive to achieve three big milestones: Entering the clinic; implementing advanced manufacturing technologies into our processes; and standardizing our manufacturing platforms.

This article discusses how cell and gene therapy companies can use prior knowledge and platforms to leverage process characterization to reduce the testing and/or studies required during process validation for drug substance and drug product manufacturing processes.

In three years, Carisma Therapeutics has gone public, entered a broad collaboration with Moderna, and ceased development of its original CAR-Macrophage candidate, in favor of CAR-Monocyte therapies. Carisma expects to release CT-0525 Phase 1 data by the end of 2024.