Article | June 16, 2016

How Are Analytical Methods Exchanged In A Technology Transfer?

Source: WellSpring Pharma Services
Wellspring

By Norm Fong, technical transfer manager, business development, WellSpring

As the principal means of assuring chemical identity and purity, instrumental analysis is the lifeblood of pharmaceutical development and manufacturing. In addition to standard instrumental methods, molecules may undergo enzymatic or cell-based assays to demonstrate some critical quality. Products often become “married” to analytical methods, and transferring this panel of tests during a technology transfer requires care.