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If everything a receiving site needed were in the transfer documents, Paige Kane points out, you could probably pull off a technology transfer through FedEx.
But of course, nobody does! Companies send process scientists to the receiving site, pull in people from the sending site, and lean on whoever was there during development. All those motions are a tacit admission that the knowledge needed to run a process consistently lives at least partly in people’s heads. Paige’s argument is that the industry should plan for that openly instead of treating the documents as the whole transfer.
She’s spent roughly 25 of her 30-plus years in the industry on tech transfer for both clinical and commercial supply. Every one of those transfers, she says, has been frustrating one way or another. That frustration eventually sent her back to school for a PhD in pharmaceutical and regulatory science, focused on why tech transfer is so hard, so we can land on a better solution.
Nick Capman asked her how pharma teams can make sure a transfer moves not only documents and processes, but also the understanding a receiving organization needs to manufacture consistently, troubleshoot problems, and make sound risk-based decisions.
Paige is Associate Vice President of Technical Excellence & Transformation at CAI, where her work centers on operational readiness and operational excellence. Before CAI, she spent nearly nine years at Merck, most recently leading its Knowledge Management Center of Excellence.
She was recently elected to serve on the International Society for Pharmaceutical Engineering (ISPE) 2026–2028 International Board of Directors.
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Paige’s key insights and practical takeaways
If you’re short on time, here are the most important lessons from the discussion.
Success in tech transfer should mean operators can run the process without any heroics. At the end of the day, Paige says, the test is simple: can the site run the plant effectively and efficiently? Too often, equipment and processes get handed over, and running them still takes a heroic effort because the products are so complex. Right-first-time is a common tech transfer metric, and she wants operators to feel comfortable running the process on the floor.
“If it’s not written down, it didn’t happen” has a downside. The rule exists for good reasons, but Paige says it’s done the industry a disservice in tech transfer because it encourages teams to assume the documents hold everything. They don’t, which is why subject matter experts from development or the sending site end up on the receiving floor.
The “know-what” transfers. The “know-why” often doesn’t. Documents usually capture what to do. Why it’s done that way, and what happens when a parameter goes out of spec, is much harder to pin down.
Your risk assessments are already capturing tacit knowledge. Treat them that way. Paige called risk assessments a beautiful expression of the tacit knowledge behind a process. The problem is that the conversations behind them are never adequately captured, and everyone is busy when they happen. She has encouraged teams to record their risk assessment discussions because of how much context comes out in them. She also wants companies to treat the risk assessment as a knowledge capture document rather than one more thing to get across the finish line.
Similar equipment isn’t the same equipment. On one transfer, the team kept seeing tolerances that weren’t as expected, and no one knew why. After digging deep, they found the agitator speed was causing a process difference nobody had seen before. Paige’s view is that more scientists in the room, or a better way of capturing what to watch for, might have caught it earlier.
Use a pre-job brief to find what nobody knows they need. Often neither the receiving site nor the sending site knows exactly what the receiving team needs to understand. Paige uses a structured conversation called a pre-job brief that asks what’s new or unique, what’s different, and what the team should be looking for. Operators’ questions in that setting reveal gaps. Those conversations rarely happen while executing a batch record or a test protocol.
Bring receiving functions in earlier than the project manager thinks. A tech transfer is a holistic event. Paige is working with companies to look beyond the facility and bring process elements in earlier, so teams understand whether equipment is ready to accept the process and whether every contributing group is ready. In very few of her transfers were the QC lab or QA truly ready, because they get left to the end on the assumption they don’t need to be involved.
Forty-seven batches right first time. Her best example is a facility that ran 47 batches right first time. There were still deviations, but the team resolved them quickly. Early on, they did a virtual “make a batch” shakedown of the whole process, asking at every step what knowledge was needed, who had it, and whether it lived in a person or somewhere else. They weren’t asking which document or which SOP. They deconstructed the process before starting, and formally documented knowledge capture during PPQ.
Peer assists get squeezed, and video could help. Hands-on training, side-by-side work, and SME interaction are critical, Paige says, but they often aren’t done as well as they could be because of time pressure. Sometimes it’s easier to do the work yourself than to stop and teach. She’d like the industry to think differently about video on the plant floor, captured for knowledge transfer rather than GMP purposes. Confidentiality hasn’t been the obstacle in her experience, since CDMOs have usually signed the relevant agreements. Conflicts with existing site procedures have been, and she sees room to rationalize how sites capture knowledge about ways of working.
The process will tell you whether people understand it. Training records show completion. Understanding shows up in outcomes: how confidently the site runs the process, how many investigations it has, and how the process is performing.
What signals drift depends on the product. Asked which process knowledge best helps a site catch drift before it becomes a deviation, Paige said it depends on the product and modality. The place to identify those sensitivities is the up-front risk assessment conversation, which brings her back to treating that work as knowledge capture.
Ask formally about lessons learned, every time. On the seventh transfer of an in-line product, Paige asked during the pre-job brief what lessons the team had from the last time. Nobody had any. She called the global process scientist, who confirmed there were plenty and pointed her to where they lived. Those lessons proved very valuable, and without the formal question, the team would have moved ahead without them. Her conclusion is that lessons need to be documented and travel with the product, which requires a formal knowledge management approach that many companies don’t have.
Changes to SOPs and batch records can be a good sign. After commercial manufacturing begins, she looks at how the process is running, along with deviations and changes to batch records and SOPs. Changes might mean the site is learning, which isn’t necessarily bad. Nick’s take was that this is a natural outcome of a good process.
Stop calling it only a tech transfer! If she could redesign the process, Paige would treat it as one holistic operational readiness project. Teams tend to focus first on equipment and then on process. She’d blend the two from the start, which ties back to involving people earlier.
One thing to bring back to your team
Paige’s methods come down to asking a few questions formally, at the right time, instead of assuming the answers are in the documents. Before your next transfer or batch campaign, try putting these on the agenda:
What’s new or unique this time? What’s different? What are we looking for?
What are the lessons from the last time we did this, and who has them?
For each step: what knowledge do we need, and who has it?
If a question gets silence, you’ve probably found a gap to work on. On the transfer where nobody had lessons, one phone call found them!
Paige Kane, PhD, CPIP, is Associate Vice President of Technical Excellence & Transformation at CAI, with more than 30 years in the biotech and pharmaceutical industries across R&D, technology transfer, commercialization, and commercial manufacturing. Before joining CAI in 2025, she was a principal consultant with Saige Digital & Quality Transformations and spent nearly nine years at Merck, including as Knowledge Management Center of Excellence Leader. Since 2014 she has been a regulatory science researcher with the Pharmaceutical Regulatory Science Team at Technological University Dublin, focused on knowledge management, quality risk management, and ICH Q10 and Q12 implementation, and she earned her PhD in pharmaceutical and regulatory science there. A longtime ISPE author and contributor, she has worked on GAMP guides including GAMP 5 and its second edition, co-led the ISPE Knowledge Management Good Practice Guide, contributed to the Pharma 4.0 Baseline Guide, and serves on ISPE’s Pharma 4.0 Advisory Board and Steering Committee. She is an APQC Certified Knowledge Transfer Specialist.
Connect with Paige on LinkedIn here.
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