Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, ...

As daunting as it seems, things can change. When I joined Methods Analytics, I was asked to build a data science function setting standards and best practices in the ways of working. At first, I ...

In today’s pharmaceutical environment, where compliance and speed-to-market are paramount, analytical method development and validation play a foundational role. From early research through to GMP ...

When transferring a method from R&D to quality control, success hinges on discovering where “the best” and “the most reliable” intersect. Analytical method transfer suffers from many of the same ...

The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...