A critical component in the drug development process can be the cGMP analytical method development and validation for solid form analysis. We understand the challenges inherent with solid-state method development and are recognized as industry leaders and experts in this field. The optimal physical analytical technique (XRPD, DSC, TGA, IR, Raman, solid-state NMR, or moisture sorption) is selected and used to develop the quantitative or qualitative methodology. In some cases, only a limit test is needed, whereas in others a full quantitative method may be required. In either case, statistical experimental design (DOE) and chemometrics are tools we frequently use in the method development/validation process. Additionally, all methods are developed and validated in light of the ICH (International Conference on Harmonization) guidelines (Q2A, Q2B, and Q6A).
Within the analytical group, we have extensive experience in developing different types of analytical methods. Whether monitoring the process efficiency for purity improvement of a selected solid form, determining the stability of a drug substance or drug product, or seeking support for patent litigation, the analytical method can be tailored accordingly. Additionally, a method can be developed based on your own in-house capabilities, in order to potentially aid in future method transfer. In conjunction with our amorphous materials characterization group, we have also worked on developing methods to quantify amorphous content in crystalline material (drug substance and drug product) or vice versa.