Introduction Welcome to our three-part blog series that closely examines process development strategies to deliver robust manufacturing processes. In part one of the series, we discuss the role of Process Chemistry during the drug development cycle.  We also explain how Process Chemistry ensures the development of a safe, consistent, and […]

In Part 2 of our series on Chiral Method Development, we discussed the features of several different types of chiral stationary phases (CSPs).  We also discussed a general approach to column and mobile phase screening, which can be helpful for identifying candidates to carry on for further method development and […]

You may have heard from many solid-state chemistry experts state that selecting the right solid-state form saves you money. However, have you considered what that statement means and the impact selecting the correct solid-state form has on your program? It means understanding your API and if it exhibits polymorphism and […]

In a previous blog, we discussed the concept of molecular chirality and its importance.  We also noted the ability to separate enantiomers using chiral chromatography.  In this installment, we’ll talk about the first steps in developing an HPLC method that will separate chiral compounds of interest. With any approach to […]

Phase Appropriate Analytical Method Validation Welcome to part two of our Analytical Strategies from Early Development to Validation blog series. In part one of the series, we discussed the purpose of analytical method development and validation and broke down processes for each clinical development phase. In this article, we will […]