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Advinus



Pharmaceutical Development
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
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