Dipak Gordhan
Associate Director of Manufacturing Operations
Nathan Collingwood
Principal Scientist
"Share your failed batches with us."
It is not what most sponsors expect a CDMO to ask for. But it’s an important question to ask.
Technology transfer in pharma is the process of moving a drug product’s manufacturing process, and the knowledge behind it, from one team, scale or site to another. Done well, it gets a formulation from the development lab into GMP clinical manufacturing without losing what was learned along the way. Done badly, it costs months.
Most people treat tech transfer as a handover of documents and equipment settings. At Upperton, we see it differently. The biggest risk in pharmaceutical technology transfer is not the equipment. It is knowledge that never makes it across: missing reports, unshared data and assumptions nobody checked.
This article draws on a conversation between members of our technical transfer and manufacturing teams. It covers what tech transfer involves, where it goes wrong, and how we reduce the risk on a single site.
What is technology transfer in pharma?
Technology transfer is the structured transfer of a manufacturing process, its data and its know-how so that a receiving team can make the same product, to the same quality, at the scale the programme needs.
“A lot of people think it’s just data transfer. Actually, it’s more about a collaborative process.” – Nathan, Principal Scientist, Technical Transfer, Upperton
In practice, tech transfer in pharma takes two forms.
Internal tech transfer: from R&D to GMP
A product developed in R&D moves into a GMP clean room, onto larger equipment and at much larger scale. In R&D, a team might press one tablet at a time. At scale, that becomes a rotary tablet press. A few grams of spray-dried powder becomes a bulk run of several kilos on a production spray dryer.
The challenge is to make sure the process transitions smoothly, has quality cover, and will support regulatory submissions, so the product is ready for the clinic.
External tech transfer: from another site
A client’s process may already run at scale elsewhere, and they want to move it. The receiving site may have a different roller compactor, a different tablet press or a different process train. The job is to make the process work on new equipment, often with further scale-up as well, and still deliver a quality product.
Both forms depend on the same thing: the receiving team needs the full picture, with as much detail as possible, whether that be good or bad.
The biggest risk in tech transfer: knowledge that never makes it across
The biggest risk in pharmaceutical technology transfer is lost knowledge, not unfamiliar equipment. The word “transfer” sounds simple. The reality rarely is, especially when a process comes from another site and is being scaled up at the same time.
Knowledge gets lost in three main ways:
- Missing reports. Earlier development work was never written up, or the reports are not available to the receiving team.
- No transparency. Data stays with the sponsor instead of reaching the project team that has to make the process work.
- Unchecked assumptions. Where information is missing, gaps get filled with guesswork.
The same risk exists inside a CDMO. A handover from R&D to GMP manufacturing can lose detail just as easily as a handover between companies, unless the teams keep talking.
The principle is simple: the more information a tech transfer team has, the more it can scrutinise, and the better it can design a process that works. When data is genuinely unavailable, assumptions are sometimes unavoidable.
At Upperton, every assumption is science-led, discussed with the client and tested across functions before it shapes a decision.
How a one-site CDMO reduces tech transfer risk
Upperton reduces technology transfer risk in four ways: early involvement in R&D, one site for all activities, mapping knowledge gaps prior to execution, and schedules built by scientists.
- Tech transfer starts early in R&D
Our technical transfer team works, in our scientists’ words, “like the glue in between those departments.” It gets involved with projects early, while they are still in R&D and keeps an eye on manufacturing activities to ensure the manufacture is as expected.
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That early involvement checks two things. First, that the process can be repeated in a clean room, not just at the bench. Second, that the materials can actually be sourced at scale.
“The last thing you want is to make something wonderful, but then you can’t do anything with it at scale because you can’t purchase that material.” — Nathan, Principal Scientist, Technical Transfer
- R&D, QC, GMP manufacturing and QA on one site
At many CDMOs, development and manufacturing sit in different cities or countries, which makes knowledge transfer harder. At Upperton, everything happens on one site, so the people who developed a process are there when it scales up. Each handover keeps its people:
- R&D to scale-up. Knowledge transfer meetings, R&D reports and data presentations feed detailed planning meetings. R&D scientists then join the tech transfer batches to check the product matches what they made, “all the little tips and tricks” included.
- Scale-up to clinical manufacturing. The tech transfer scientist is present for the first clinical batch, on the same equipment in the same facility.
- Quality throughout. QA and QC are involved from the early phase, so the work is ready for clinical GMP manufacture as soon as results are agreed.
3. Knowledge gaps are mapped before anything is written
For client processes coming from another site, we ask for much more detail up front: reports, data presentations, and information on raw materials, equipment and consumables. From that, we prepare a knowledge transfer document that maps any gaps in knowledge. Only then do we write protocols and batch records.
When required, the data from tech transfer batches goes into design of experiments (DoE) software to pull out trends and potential issues further down the line. That analysis produces a report with recommendations for clinical manufacturing.
- Schedules are built by the scientists doing the work
Our project managers keep every team organised and communicating. But project schedules are built on input from the scientists who know how long processes take, where materials can be sourced and what they are likely to cost.
“We’re science-focused, not just trying to meet a deadline that we can’t necessarily meet because the science says no.” — Nathan, Principal Scientist, Technical Transfer
What sponsors should share for a successful tech transfer
The most useful thing a sponsor can do before a technology transfer is share everything, failed batches included. Our team’s advice to biotechs is to be transparent and provide:
- Raw material information for every material in the process
- Consumables used in the existing process
- All development reports and data presentations
- Unexpected data, even when results were not what you hoped
- Data from failed batches, and what you learned from the failure.
Failed batches matter because understanding why a batch failed stops the receiving team repeating the same mistake. A sponsor who shares them is treating the CDMO as a partner rather than a service.
Then come on site:
- Ask how the tech transfer will run. After the initial phase, ask us exactly how we plan to transfer and scale up your process.
- Join the planning meetings. We hold on-site planning meetings to go through existing data and the scale-up plan.
- Watch your batches being made. Few sponsors get to see their product manufactured in person, and we make this possible.
- Bring your experience. Many of our clients have spent decades in the industry. That knowledge is valuable on the manufacturing floor.
What sponsors should share for a successful tech transfer
The most useful thing a sponsor can do before a technology transfer is share everything, failed batches included. Our team’s advice to biotechs is to be transparent and provide:
- Raw material information for every material in the process
- Consumables used in the existing process
- All development reports and data presentations
- Unexpected data, even when results were not what you hoped
- Data from failed batches, and what you learned from the failure.
Failed batches matter because understanding why a batch failed stops the receiving team repeating the same mistake. A sponsor who shares them is treating the CDMO as a partner rather than a service.
Then come on site:
- Ask how the tech transfer will run. After the initial phase, ask us exactly how we plan to transfer and scale up your process.
- Join the planning meetings. We hold on-site planning meetings to go through existing data and the scale-up plan.
- Watch your batches being made. Few sponsors get to see their product manufactured in person, and we make this possible.
- Bring your experience. Many of our clients have spent decades in the industry. That knowledge is valuable on the manufacturing floor.
Technology Transfer FAQs
What is technology transfer in the pharmaceutical industry?
Technology transfer in pharma is the transfer of a drug product’s manufacturing process, data and know-how from one team, scale or site to another. Its goal is that the receiving team makes the same product, to the same quality, at the scale the programme needs.
What are the two types of pharma tech transfer?
The two types are internal and external tech transfer. Internal tech transfer moves a process from R&D into GMP manufacturing at larger scale. External tech transfer moves an established process from another company or site onto new equipment.
What is the biggest risk in technology transfer?
The biggest risk is knowledge that never makes it across. Missing reports, data that is not shared and assumptions nobody checked cause more problems than unfamiliar equipment.
What should a sponsor share before a tech transfer?
A sponsor should share development reports, data, raw material and consumables information, unexpected results and data from failed batches. Knowing why a batch failed helps the receiving team avoid repeating the same mistake.
How does a one-site CDMO reduce tech transfer risk?
A one-site CDMO keeps R&D, GMP manufacturing and QA in one place. The scientists who developed a process can attend scale-up and the first clinical batch, so knowledge passes directly between people instead of through documents alone.
What is a knowledge transfer document?
A knowledge transfer document records what is known about an incoming process and maps the gaps. At Upperton, it is written before any protocol, batch record or design of experiments, so planning starts from a complete picture.