Drug substance manufacturing

Ardena provides comprehensive drug substance manufacturing, including both non-GMP and GMP, enabling us to take a holistic view of your drug development project from molecule to clinic. Our expertise and capabilities cover:

  • Drug substance manufacturing from mg to 30kg quantities
  • Integrated drug substance service with capacity for multiple projects
  • Production of complex chiral molecules that require long synthesis routes
  • Containment infrastructure to support production of drug substances up to and including OEL 4 potency
  • Dedicated materials management group that sources high quality, validated raw materials from established, cost competitive supplier base
  • Production plant housing GMP kilo labs (170sqm), 4 GMP manufacturing suites, GMP synthesis lab dedicated for peptides, weighing booth and grade C cleanroom