June 18, 2025
June 18, 2025
So, you're thinking about Technology Transfers (i.e., TT or Tech Transfer)? This question may look familiar to you. That is because we asked this very question in the first installment of our Tech Transfer blog series Technology Transfer Projects: Assessing Need and Readiness. In that blog, we talked about identifying the need for a Tech Transfer as well as identifying if you are ready to lead your own Tech Transfer.
Not to give too much away, but there are more than 70 steps from the inception of the need for a technology transfer to actually getting it done. Seventy, plus! Technology transfers are complex projects. They require a coordinated effort from almost every workstream of the transferring facility and the one it is being transferred into equally. It is a significant balance between quality, schedule, timeline, and cost.
As a reminder from our previous blog on this topic:
Tech Transfer does not only occur for commercial products or during commercialization. At some level, tech transfer can occur at any phase during development through commercialization. We are all aware that Tech Transfer occurs 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.
There are a lot of moving parts to a tech transfer. The sheer number of activities surrounding a tech transfer can be overwhelming if you are not experienced and if you have not developed a comprehensive, integrated Tech Transfer Plan.
Here is just a snapshot of just some of the tasks you need to address:
Remember the five "C"s of CMO selection when your technology transfer involves a CMO or CDMO: capability, compliance, capacity, customer service, and cost. Does the CMO have the ability to meet your product's requirements in each of these areas to ensure competitiveness?
Knowing your stakeholders and identifying them early in the tech transfer project planning process will lead to alignment on the need and the scope, as well as early buy-in of the tech transfer project. Having a communication plan and understanding the needs of not only the decision makers (i.e., stakeholders) but, at times, also the executing bodies (i.e., SMEs, Tech Transfer project team members) will lead to success.
Do you have buy-in from management that this tech transfer project is a priority? Is this tech transfer project part of the strategic goal of your organization? If these questions are addressed early on, budgeting and funding generally follow. Do not fall into the pitfall of assuming buy-in and budget are a given. If you initiate a tech transfer project with such assumptions, there is a high risk of the project failing (i.e., halting).
Whether they are fully dedicated to the tech transfer project or asked to make themselves available at the appropriate inflection points of the project, identifying not only the governance of the project but also the SMEs and workflow team members is vital. A successful tech transfer project requires effective leadership. (Well, let's face it, this is true for any project – not just tech transfer projects.) Project leadership comes from the Sponsor, all the way through to the Project Manager and the stakeholders. However, those executing the work must understand their role in the project, including when they are needed, the expectations, and the deliverables. It is the responsibility of leadership to communicate the availability of resources, and the Project Manager is responsible for outlining when and how much each resource is needed for the project. With this information, planning can truly occur. And as we have mentioned prior, a well-planned tech transfer project is a successful tech transfer project.
Understanding and mitigating risks is a critical aspect of all work within the healthcare industry. Technology Transfers have inherent risks that must be identified, mitigated or controlled to ensure the safety and availability of products. Utilizing ICH Q9 Risk Analysis tools to facilitate risk control is a requirement that needs to be managed by qualified experts.
For both the transferring organization and the organization being transferred to, some form of Regulatory communication will likely be required. It is likely some form of filing or special communication, but having this plan in place from the beginning of the project will ensure no untimely surprises at the end of the tech transfer project. Agreeing on the Regulatory strategy up front will help in the planning and the required timing for executing the necessary Regulatory strategy.
For companies that are not prepared, tech transfer can be a significant change for both the organization and its personnel. New or changes in processes, roles, equipment, metrics, etc., will be incorporated in the ways of working at the receiving location. Clear communication and oversight will allow proactive awareness and the ability to address issues as they arise. A clear understanding of the change, its impacts, and how to address it will help in facilitating a successful tech transfer process.
Whether it is procurement and installation, qualification and validation, or requalification and revalidation, these are important attributes to any tech transfer project. And as we have all experienced, Qualification and Validation are critical and time-consuming. This aspect of a tech transfer project needs a lot of planning and communication – from supply to documentation to change controls to implementation.
This may be self-explanatory, but ensuring the equipment, systems, specifications, process, etc. acceptance criteria are established, documented, and communicated is of the utmost importance.
The identification and sourcing of materials of any kind are equally important to a tech transfer project as they are for any biotech project or process. And having a plan for this along with everything else that goes along with material sourcing (methods, specification, validation, etc.) will ensure timely completion and limited risks for your tech transfer project.
Readiness for qualification and validation includes equipment, systems, and material sourcing and delivery, as well as protocol generation and execution. But the planning for these readiness prerequisites along with the various engineering runs ahead of a PPQ, is nothing in contrast with the gravity of ensuring successful qualification and transfer of the process, but they are cumbersome tasks.
Certainly, akin to qualification and process validation (or as we know it now, PPQ), release testing and stability testing ensure that the processes at the firm accepting the transferred processes have met expectations and acceptance criteria from the transferring firm via comparability studies.
Keep in mind, as daunting as the questions and tasks above seem, these are just a few of the many questions you must ask yourself and just some of the many tasks that need to be planned and accomplished for a successful tech transfer.
ProPharma's Nine Gate Technology Transfer approach provides a regimented process to consistently transfer production technologies from development to production or from site to site, efficiently and in compliance with applicable regulatory agencies. Because we understand that schedule is a critical measuring tool, by employing this documented process you are less likely to miss key milestones during the transfer. In conjunction with our project managers, who are experienced in project management, process engineering, quality assurance, and more, this robust process increases the probability of a successful transfer. Contact ProPharma today.
