Our Goals: Creation of effective production processes and development of future defining projects

Our work is aimed at continuously optimising existing production processes and developing innovative biological active pharmaceutical ingredients and drug products. In doing so, we service the full process range, from extraction, fermentation, purification and characterisation of proteins, via the development of the required analytical procedures, all the way to establishing GMP compliant manufacturing processes and the performance of ICH compliant stability studies, method validations and formulation of the finished pharmaceutical product.

Research & Development: Departments and responsibilities at Nordmark

Process development (APIs, Active Pharmaceutical Ingredients)

  • USP and DSP of eukaryotic and prokaryotic protein production for the manufacture of active pharmaceutical ingredients and biochemicals from laboratory to production scale
  • Manufacture of active pharmaceutical ingredients under GMP for clinical trial material
  • Manufacturing process support and optimization
  • Compiliation of documents for drug approval applications

Research

  • Analytical laboratory: Development of new analytical methods including ICH compliant validations and initial routine testing in support of active pharmaceutical ingredients and drug development
  • Planning and implementation of preliminary, ICH compliant stability and stress studies
  • Research laboratory: Development of new active pharmaceutical ingredients based on the Nordmark product portfolio
  • Cell culture and virus laboratory: State of the art cell-based and molecular biology analytical methods as well as laboratory scale cell culture fermentation
  • Compilation of documents for drug approval applications 

Pharmaceutical Development

  • Formulation development of solid and non-solid formulations from laboratory to production scale, based on the Nordmark product range
  •  Manufacture of test preparations and stability samples
  • Operations support, process optimisation
  • Project and cost management
  • Generation of pharmaceutically appropriate documentation and of documents for regulatory approval worldwide

Packaging Development

  • Development of primary and secondary packaging
  • Compilation of packaging specifications
  • Verification of incoming packaging in respect to specification compliance and text accuracy
  • Creation of graphics layout according to customer specifications
  • Generation of regulatory approval documents for the Packaging area