10.03.26 -- Advancing RNA Newsletter Best Of September

Here, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”

How well do we know our mRNA-LNP drug products today? In this discussion, Advancing RNA panelists unpack what we continue to learn about the analytical methods we have at our disposal today, while identifying which attributes we should be paying closer attention to today.

As RNA therapies expand beyond the liver, delivery—not payload design—has become the defining challenge for precise, scalable in vivo cell engineering.

Cutting-edge analytical technologies enable accurate quality attribute assessments across mRNA drug substances and drug products, ensuring process control and regulatory readiness.

Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.

Align manufacturing rigor with clinical phases in CGT development to deliver targeted quality, reduce overall costs, and accelerate timelines without compromising integrity.