Our experienced team of scientists and drug development experts will help you navigate the development of your compound and gain strategic insight into manufacturability. With wide-ranging capabilities across drug substance and process development as well as drug product formulation, we can support your program from IND through commercialization.
Our capabilities include chemical process R&D via batch mode and continuous flow, manufacturing of non-GMP and GMP intermediates and clinical-stage APIs, biotransformations, enzymatic reactions, preformulation/formulation and material science. Regardless of project complexity, our seasoned scientists—highly skilled in route scouting and process optimization for manufacturing—will partner closely with your project team.
You’ll also benefit from our powerful analytical method development capabilities to determine the solid form(s) of your active drug in formulations and the stability of the drug product and formulation. Our teams are experts in developing and analyzing amorphous formulations for enhanced solubility. We routinely develop full quantitative and limit test assays under cGMP to monitor the solid form in drug substances and drug products. We also issue certificates of analysis for lot release on both the drug product and drug substance.