Mahesh Karwa: The People Behind mRNA and Delivery Shuttles
The pivot from very small quantities of mRNA vaccines or therapeutics to large-scale production isn't trivial.
September 22, 2023 | 2 min
Mahesh Karwa and his colleagues spend a lot of time thinking about experimenting with how to develop and scale up processes. They need to bring custom components — including custom mRNA and lipids — together seamlessly and consistently to create a final product. The final steps of the process are aptly named “fill and finish.”
Creating and scaling up processes for drug products or vaccines isn’t as simple as doubling, tripling or quadrupling a prescribed recipe. It takes careful calculations, iterations and adjustments. Whether making one milliliter or 1,000 liters, the final product must “look” the exact same, chemically speaking.
The team in Indianapolis, US, works closely with customers and colleagues across Merck to bring together custom mRNA, lipids and other materials to create a vaccine or therapeutic product that’s ready to enter clinical trials and, ultimately, the market. The site might select specialized lipids from Haag’s team and formulation instructions from Samaridou’s group.
Serving as a contract, testing, development and manufacturing organization (CTDMO) for the mRNA value chain, Karwa works closely with a wide variety of teams across Merck — from sites that manufacture lipids and mRNA to the team that develops and screens novel formulations. Karwa describes the expertise across Merck as specialized “modality boutiques”.
When shopping at boutiques, it’s common to pick up different parts of an outfit at different shops. Each craft requires a distinct skill set. At one, you’ll get a hat. A couple of shops down is the one that sells leather shoes. And the boutique across town specializes in clothes. When all is said and done, the styles complement each other and the outfit is top notch.
At Merck, different groups specialize in different aspects of the mRNA value chain. They work collaboratively to meet customer needs and, ultimately, produce a final LNP that shines.
“It’s a shared journey filled with many expectations,” says Karwa. “Not just between our team and our clients, but the patients and their families who put hope into a clinical trial.”
More people behind mRNA and delivery shuttles
Before custom LNPs are finalized, there are numerous LNPs that don’t make the cut.
Before there are LNPs, there are individual lipids.
Before a process is optimized, there are many, many, tweaks.
Before the time from idea to final RNA therapeutic or vaccine can shrink, scientists need to formulate viable LNPs.
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