At ProJect Pharmaceutics CRO, we offer the expertise and flexibility to replicate your clinicaltrial conditions to evaluate the stability of your drug product during real application scenarios. Whether administered through bolus injection or infusion, we can replicate your specific procedures using the relevant materials and equipment (e.g. perfusor syringe pump, Closed System Drug-Transfer Device (CSTD), IV bag, IV line set, etc.). We also assist in identifying the most suitable filter units, tubing systems, and other necessary materials. Should any adsorption issues arise, we aid in identifying the most appropriate stabilizing agents at optimal concentration to align seamlessly with your DP formulation and manufacturing processes (i.e. lyophilization).
We conduct in-use stability studies for all classes of molecules for which we also offer formulation development and process development, i.e. biologics, ADCs, cytotoxic drugs, small molecules, and peptides. Our in-use safety laboratory is equipped with infusion stands for infusion via gravity and with perfusor pumps. We also operate a red-light laboratory for handling light-sensitive substances.
