Active pharmaceutical ingredient (API) and/or drug substance availability, timeline requirements, and the need for method qualification or validation differs significantly between discovery, preclinical and clinical stage.

Accordingly, all projects at Coriolis are tailored to the development stage of your drug product. We focus on your specific needs and target product profile when compiling a study plan, so you achieve your development goals without changing your overall strategy or exhausting your precious drug substance material or timelines.

For most biopharmaceuticals, a liquid formulation is desired. However, if the anticipated stability or shelf-life cannot be achieved, or you aim to enter the clinics fast at low risk, lyophilization is a valuable alternative. Coriolis combines many years of experience in developing liquid and lyophilized formulations, subsequently or in parallel, with a large portfolio of analytical techniques for both, liquid and lyophilized samples. We tailor the formulation development approach to fit your timelines and budget. This includes the design, development, optimization, robustness testing, scale-up, and transfer of entire freeze-drying processes or liquid formulation procedures.