Naga Mounika Nuguri

Why this site exists

Every modality I have worked in broke something I thought I already understood. Small molecule process validation did not prepare me for a device UDI submission. Device work did not prepare me for building PPQ and PAI readiness on the first approved RNAi-LNP therapeutic. None of that prepared me for cryoformulation on an autologous cell therapy, or for tech transfer on a commercial-stage gene therapy with a person-in-plant program running at the same time. Every step, the fundamentals held, but the specifics changed enough that I had to relearn how to apply them.

I could not find much written about that relearning. There is plenty on classical process validation, and plenty of regulation to read on its own terms, but very little that walks through what changes when the product is alive, unstable, or made in single-digit batch counts, and what stays exactly the same. What a CDMO technical assessment actually needs to catch before transfer, not after. What a validation master plan looks like when the process is still moving under you.

This site is that missing layer, written the way I would explain it to someone joining my team: what the guidance says, what it means on the floor, and what I would actually check before I signed my name to it.

The mission is simple: take what took over a decade of tech transfer, validation, and drug product work to learn in practice, and make it available for free, at whatever level you are starting from.

Where this comes from

I started in quality and process validation at Novartis, working continued process verification programs on small-molecule manufacturing. From there I moved into devices at Medtronic, where UDI, GUDID, and 21 CFR 820/Part 11 taught me a different kind of discipline around identification and record integrity.

The real turn came at Alnylam, running process characterization and validation on ONPATTRO, the first FDA-approved RNAi-LNP therapeutic, and GIVLAARI, the first approved GalNAc conjugate, both Breakthrough Therapy-designated. Building PPQ and PAI readiness for products that had never been approved before meant there was no precedent to copy; you had to build the argument for why the process was in control and defend it. From there I moved to Wave Life Sciences, working oligonucleotide drug substance and drug product validation and a CCIT program under USP <1207>.

At SQZ Biotech I led a small team of engineers on process development and manufacturing for an autologous cell therapy, including cryoformulation and IND CMC, work where the product is the patient's own cells and there is no room to redo a batch. At Sarepta I ran drug product MSAT for commercial-stage gene therapy tech transfer, PPQ campaigns, and person-in-plant oversight, and authored CMC sections across IND, BLA, and NDA submissions. I currently lead drug product development at a clinical-stage RNA-editing biotech in Cambridge, Massachusetts.

Twelve-plus years in, the pattern I keep coming back to: the technical fundamentals of tech transfer and validation transfer across modalities almost completely. What changes is the tolerance for being wrong, and that is exactly what this site tries to teach.