Technology Transfer Projects: Assessing Need and Readiness

So, you're thinking about Technology Transfers (i.e., TT, Tech Transfer)? Who can blame you? There has been a significant amount of news recently regarding tariffs and the potential for bringing manufacturing back to the United States. If your manufacturing is outside the United States, then this news will certainly keep Tech Transfer on your mind. Of course, technology transfers occur for other reasons. We will dive into that as well.

But how do you know if you need tech transfer, and how do you know if you are ready to lead a tech transfer yourself?

Before we get to that, let's discuss the topic in general and outline some definitions. No matter what you call the process, whether you call it technology transfer, technical transfer, tech transfer, transfer of technology, or even TT, it means the same thing. It is the transfer of knowledge and science for one or more drug products, one or more drug substances/API, one or more in-process/bulk products, or one or more analytical processes (known as Analytical Method Transfer). Tech transfer can occur between two sites or locations or within the same site or facility.

And let it be known that tech transfer does not only occur for commercial products or during commercialization. At some level, Tech Transfer can happen at any phase during development through commercialization. We are all aware of tech transfers occurring from one CDMO to another (or even to a sponsor's own manufacturing facility) for a commercial product. However, there can be a Tech Transfer or a knowledge transfer during development or scale-up as well. This can occur, for example, from the Product Development location to the Pilot Plant or Manufacturing Sciences plant.

So, back to the questions at hand – how do you know if you need a tech transfer, and how do you know if you are ready to lead a tech transfer yourself?

Need

The need for tech transfer can occur as a reactive strategy or a proactive strategy. Whether your organization is looking ahead and planning for the future (proactive) or has been informed of issues at the current facility that are impacting your supply (reactive), the need is easy to identify.

Reactive Strategy

• Compliance concerns
• Closure
• Scheduling/Capacity limitation (delays in manufacturing or testing)
• Patent expiry

Proactive

• Capacity (proactive – pipeline preparation)
• Business need
• 2nd source for manufacturing, testing, etc.
• Technology and Innovation (facility, equipment, processes, etc.)

Readiness

By asking just a few seemingly simple questions, our industry experts can tell you if you are ready to lead your own tech transfer. However simple these questions may seem, the answers provided pack a punch for your ability to initiate Technology Transfers yourself.

Questions to ask yourself in preparation for tech transfer:

1. Is your Tech Transfer project strategically planned, resource loaded and prioritized?
2. Does your Tech Transfer project have an owner, does it have buy-in from the organization, and does it have structured governance/oversight?
3. Do you have highly engaged stakeholders and SMEs, assigned or on-demand, for the project to achieve the desired progress?
4. Do you have effective controls in place to quickly identify when the Tech Transfer goes off track? Do you have respective corrective actions such as a "Stage Gate" approach? – an outlined, proactive, transparent, and timely plan for Tech Transfer completion?
5. Do you have a risk register (identified risks, assessed risks, communicated risks, mitigated risks) for your Tech Transfer project to mitigate delays or disruptions?
6. Do you have the sufficient resources required, both in expertise and in sufficient quantity?
7. Do you have a communication plan to ensure the project manager, the stakeholders, and the SMEs, have all of the latest information regarding your tech transfer project and are effectively managing change?
8. Have you done such tech transfer projects in the past and have they been successful (on time and on budget greater than 75% of the time)?
9. Do you have established and trusted tech transfer methodologies, templates, etc.?

If you have answered "yes" to 3 or fewer of the questions above, your tech transfer project may be in trouble. Reach out to a tech transfer expert like ProPharma for help. If you have answered "yes" to at least 7 of the above questions, great job. Contact ProPharma if you need help with the remaining steps. On second thought, can you afford not to answer "yes" to all of these questions? Can your timeline, your budget, or even your patients afford that?

Time lost has a critical impact on your organization, your product, and your patients. In the next installment of our blog series on Tech Transfer, we will discuss ProPharma's approach to Tech Transfer Readiness. And here is a spoiler – our process is streamlined, gated, and reduces risk and time.

The figure above outlines the wastes: time and budget. By truly not understanding and planning the Tech Transfer project appropriately, time and budget are wasted. By not using a proven process, time and budget are wasted. As many Project Managers have witnessed and encountered time and time again, "We don't have time to plan – we need to start the project now." The performance of any project, including Tech Transfer projects, benefits from a well-planned execution. If the appropriate planning does not occur up front,

• Risks may be misidentified
• Unplanned downtime can occur
• Confusion due to unclear roles and activities
• Waste (time, materials, assets)
• Low Yields

Please look for our next installment of this blog series Tech Transfer Readiness: Big Responsibility, Greater Reward to understand if you are ready to begin. In the meantime, please feel free to contact ProPharma to get a head start on the process.

Blog Author

Simona Mills

Director, Product Lifecycle Management