Keys to Executing a Successful Technology Transfer - Pharmaceutical Technology

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Keys to Executing a Successful Technology Transfer
The authors highlight the need for a technology-transfer process that is efficient, cost-effective, and repeatable, stressing the importance of process understanding. Read this and other preferred organization articles in this special issue.

Pharmaceutical Technology
Volume 35, pp. s42-s46

The overarching framework

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)
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.

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 process.

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.

European Medicines Agency proposes revisions to technology-transfer GMPs: A Q&A with David Cockburn
Transfer strategy. 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?

Bottom-line focus. 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.


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