Topic area
Tech Transfer & NPI
Technology transfer is where a process either survives contact with a new site or quietly falls apart. This pillar covers new product introduction, technical transfer protocols and reports, process characterization, scale-up and scale-down, comparability, and the engineering runs that come before a process performance qualification campaign.
2 articles23 documents
- Beginner→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.
- Intermediate→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.