Accelerate Bioassay Transfer In GMP

Accelerating Bioassay Transfer in a GMP Environment

Author: Ana T. Menendez, PhD, Catalent

Considering the pressures on biopharmaceutical companies today: the more efficient and transparent your bioassay method transfer processes, the faster your track to regulatory submission. The author, senior director of biotechnology at Catalent, says that setting realistic timetables, creating thorough documentation to transfer assays between organizations, and working with highly qualified and experienced CROs are key to streamlining the production of biologics and accelerating their time to market. She also gives a detailed analysis of how to write a successful method document.