Animal organ extraction

Nordmark is offering an all-in-one solution for approval of drug products originating from animal organ extracts. Due to approved market products manufactured by Nordmark our know how is based upon several decades of experience with the corresponding technologies and the regulatory framework. Nordmark covers the entire value chain from process development, formulation, analytics, production of API and finished drug product up to regulatory affairs and marketing. Our worldwide customers benefit from this integrated approach, which is improved by solid project management, long-standing GMP experience, biosafety expertise and routine in inspections by different authorities (FDA, BfArM etc.).

Services for animal organ extracts

Nordmark offers a comprehensive service package for the approval of drug products produced from animal material. Customers can expect an outstanding experience in:

  • Extraction techniques (organic solvents, supercritical CO2)
  • Filtration and drying techniques
  • Milling and sieving
  • Implementation of virus removal/inactivation steps
  • Virus studies
  • Formulation development
  • Analytical development
  • Detailed product characterization
  • QbD approach in process development
  • Regulatory support
  • Planning of production facilities
  • Quality assured sourcing of animal organs
  • Highest GMP standards from technical to production scale
  • Stability studies

Animal organ extraction

ProcessesSourcingExtractionVirus reduction 
AnalyticsVirus studiesCharacterizationComparabilityStability Studies
ServicesTech TransferProcess developmentProject Management 
SupplyClinical supplyCommercial supply