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Process Development and Synthesis
Advinus' 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

