Methods on the Move:Addressing Method Transfer Challenges for the Biopharmaceutical Industry

摘要

Analytical method transfers are essential components of the current global biotechnology environment. Analytical method transfer can be defined as "a documented process that qualifies a laboratory (the receiving laboratory) to use a validated analytical test procedure that originated in another laboratory (sending laboratory), thus ensuring that the receiving laboratory has the procedural knowledge and ability to perform the transferred analytical procedure as intended" (l). The goal is to ensure that a method continues to perform in the validated state regardless of a change in the testing laboratory. Transfers can occur between laboratories at the same site, between sites at the same company, or between companies and/or regulatory laboratories. The requirements for such transfers change throughout the lifecycle of a method.