The overarching framework
Technology transfer encompasses a broad range of activities that must be properly managed for effective, efficient completion.
It begins with the end: a definition of when transfer can be considered successful and complete. Technology transfer should
be defined as complete when the process is operating in a reliable (i.e., predictable) manner within the established specifications
at the receiving site. With this objective in view, an overall framework (see Figure 1) in which that goal can be achieved
should include the following ideas.
Figure 1: A technology-transfer framework depicting some of the major capabilities and support systems that need to be in
place to support technology transfer. (FIGURES ARE COURTESY OF THE AUTHORS)
An overall transfer-program-management process.
This process includes a governance structure, the establishment of executive sponsorship, and the clear delineation of roles
and responsibilities—including the roles of all support functions, such as quality or regulatory—for all transfers. This program-level
process enables a company to manage its technology transfers as a portfolio, apply risk-management techniques to the portfolio
as a whole, and optimize the return on investment.
A project-level management for the transfer of each product or process.
This includes a "by design" set of requirements, activities, decision points, milestones, and best practices that ensure timely,
well-documented transfer within budget and with minimal impact on product sales. At the project level, the framework encompasses
the advances made during the past 25 years in process improvement and risk management and applies those advances to the technology-transfer
Gap and risk analysis at program and project levels.
At the program level, the overall transfer capability should be determined (e.g., plant capabilities and capacities, project
management capability, dedicated personnel, level of training, and understanding of regulatory and safety issues) with a view
to determining organizational shortfalls and correcting them. At the project level, the project team should closely examine
each product or group of products for shortfalls, especially the current state of product-related process understanding and
the factors that will determine success at the receiving site, including manufacturing processes, documents, analytical methods,
equipment, plant capabilities, and regulatory and safety issues.
Based on the gap analysis, a detailed strategy document must be developed to include all gaps, the means to fill those gaps,
and a description of the overall transfer strategy with measures for success. One of those key measures of success will be
knowledge transfer. Will the organization be left with experienced personnel who can repeat the process rapidly, consistently,
and at lower cost than before?
European Medicines Agency proposes revisions to technology-transfer GMPs: A Q&A with David Cockburn
Technology transfer should be assessed, defined, designed, and managed from a comprehensive value perspective to capture the
full benefits of the transfer. Metrics that translate into value could include, but are not limited to, the following: meeting
budget, meeting timelines, the validation success rate, the number of FDA observations during preapproval inspection, the
regulatory-submission approval rate, labor hours by job title, labor costs (internal and external), capital, expense, and
potential effects on sales.
An overarching framework composed of those features not only creates the conditions necessary for a successful transfer from
a technical point of view, but also ensures that the organization reaps the full business benefits of transfers.