Unraveling the Complexities of Technology Transfer

摘要

In the biopharmaceutical industry, technology transfer refers to transfer of any process, together with its documentation and professional expertise, between development and manufacture or between manufacturing sites (l). This operation is common in the biopharmaceutical industry for a number of structural reasons. They include the dichotomy between small, innovation-based drug companies and large ones able to conduct late-phase clinical development and endowed with manufacturing capacity; the high capital cost of biopharmaceutical plants, which makes contract manufacturing attractive; and the need for multiple scale-ups during a product's life cycle."Tech transfer" is a delicate operation carrying business, regulatory, product quality, and technical risks. The basic principle is simple enough: Originators transfer all their know-how to recipients to enable product manufacture. Even in that basic rendering, some difficulties are detectable: It is not a physical asset that is being relocated or duplicated, but an ability — something much harder to define, specify, and get right. Both originators and recipients might need to overcome geographical, organizational, technical, and other discontinuities. Add to those concerns the delicate nature of biopharmaceutical processing, and the complexities of tech transfer emerge: It is a difficult-to-define task relating to inherently complex manufacturing processes that can have multiple variations depending on what discontinuities must be addressed.