Covalidation strategies to accelerate analytical method transfer for breakthrough therapies

An important operation in the registration approval of a new drug product is the commercial-scale validation campaign at a receiving manufacturing site, which requires the technology transfer of analytical methodology from the transferring site. Traditionally, Bristol-Myers Squibb (BMS) used the comparative testing technology transfer model. In a recent launch of a product with breakthrough designation status, however, BMS used the covalidation technology transfer model, which involves simultaneous method validation and receiving site qualification. The authors describe the development and implementation of covalidation strategies to accelerate analytical method transfer using examples from a pilot study.