Author Archives: Kathy Lee

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

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” (1). The goal is to ensure that a method continues to perform in the validated state regardless…