Process Development Service
Price On RequestAdvinus' Chemistry department supports the pre-clinical and early clinical development programs by providing services in the areas of Process Chemistry, Custom Synthesis and Medicinal Chemistry in selected therapeutics areas. With our best-in-class infrastructure, we can do synthesis from milligram to kilogram and multi-kilogram scale. We have a kilo lab and a versatile cGMP pilot plant. Advinus competence in process research enables development of economically efficient and scale-up friendly processes that can lead to speedy development of drug candidates. Process Chemistry Services Process development Process optimization validation Process improvement Scale-up Complete process analytical package including impurity profiling working standards Technology development and transfer services along with the process, analytical and engineering dossier Supply of NCE-API for clinical studies from cGMP pilot plant Custom synthesis from grams to kilograms scale Synthesis of new salts polymorphs Metabolite synthesis Asymmetric synthesis, chiral separation, carbohydrate chemistry Pre-formulation Services Active pharmaceutical ingredient API testing Physical characterization Solubility and pKa determination Partition coefficient determination Crystal properties and polymorphism Excipient compatibility studies Chemical stability profile Specification for drug substances