Learning Paths · Naga Mounika Nuguri

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Tech Transfer

Own your first tech transfer

Four articles, in sequence, that walk you from the ground up on tech transfer through owning a transfer to a CDMO: what to assess before you commit, how to keep technical ownership once someone else is running the process, and how deviations and change control work across that boundary afterward.

Step 01

Technology Transfer for Advanced Therapies: How a Transfer Actually Gets Done

How to run a technology transfer for cell, gene, and RNA therapeutics: the document spine, phase-appropriate rigor, engineering runs, and the handoff criteria that make a transfer actually done.

Why it comes here
Start with the complete transfer sequence so you know every phase before you own a piece of one.
Step 02

Technical Assessment of a CDMO Before You Sign

How to run the technical assessment, capability, capacity, culture, equipment fit, analytical readiness, and data systems, that turns CDMO selection into a defensible technical agreement instead of a leap of faith.

Why it comes here
Before you commit a process to a receiving site, this is what you actually assess.
Step 03

Person-in-Plant Oversight: What a PIP Is Actually For

Person-in-plant oversight at a CDMO: what to watch on the floor, virtual versus on-site models, and how to drive CAPA to closure without becoming the contractor's second QA unit.

Why it comes here
Once the transfer is running, this is how you keep technical ownership of a process you do not operate day to day.
Step 04

Deviations and Change Control Across a CDMO Network: Who Really Owns What

How to run deviations, root cause investigations, CAPA effectiveness verification, and change control across a network of contract manufacturers, from what the quality agreement actually buys you to the metrics that reveal a partner's quality system drifting.

Why it comes here
The transfer is not done at PPQ. This is how deviations and change control get managed across the sponsor-CDMO boundary afterward.

PPQ

PPQ from zero

Four articles, in sequence, from the validation master plan that everything else traces back to, through PPQ readiness, Stage 3 continued process verification, and how the validation evidence actually gets written into a filing.

Step 01

Validation Master Planning for a Clinical-Stage Biotech: Getting Started the Right Way

What a Validation Master Plan is for, how to scope it by risk instead of habit, and how to keep it a living document an inspector can actually follow.

Why it comes here
Every PPQ campaign traces back to a validation master plan. Start with how one gets built.
Step 02

PPQ Readiness: The Prerequisites That Decide Success Before Batch One

What Process Performance Qualification readiness actually requires: the process, analytical, documentation, and CDMO prerequisites that decide whether a PPQ campaign succeeds, checked before batch one starts.

Why it comes here
What has to be true, on paper and on the floor, before a PPQ protocol is ready to execute.
Step 03

Continued Process Verification: Building a Stage 3 Program That Actually Monitors

How to build a Stage 3 CPV program that catches process drift before it becomes an OOS, covering parameter selection, control charts versus capability indices, escalation rules, and right-sizing for batch volume.

Why it comes here
Passing PPQ is not the finish line. This is the ongoing program that keeps the process in a state of control after it.
Step 04

CMC Validation Summaries for Regulatory Filings: Writing the Process Validation Story a Reviewer Can Follow

What INDs, NDAs, and BLAs actually require for process validation content, how to write S.2.5 and P.3.5 sections and PPQ summaries a reviewer can follow, and how to handle review-cycle questions and pre-approval inspection readiness.

Why it comes here
How the validation evidence actually gets written into the CMC section a reviewer or inspector will read.

How to use these paths

Read each path in order. The articles build on each other: an engineering run strategy makes more sense once you have read the transfer article it feeds; a CPV program makes more sense once you understand what PPQ was actually trying to prove.

If you are not sure which path to start with, match it to what is on your desk this week rather than your title. A first-time tech lead running a PPQ campaign should still start with the PPQ path.

Both paths sit inside the full topic areas in Topics, and the ready-to-use protocols and forms that go with them are in the template library.