From Drug Candidate to drug Product

Nordmark Biotech is a leading provider for the development and manufacturing of active pharmaceutical ingredients (API) and drug products of biological and biotechnological origin.
Capabilities include:

  • Microbial fermentation
  • Mammalian / CHO- based manufacturing
  • Downstream processing
  • Formulation, fill & finish and packaging

The Specialist for GMP Protein Production

Cell line development

Mammalian cell lines and Microbial strains

  • Screening
  • Clone selection
  • Clone optimization
  • Genetic engineering
  • Cell banking under cGMP

    • Master Cell Bank (MCB)
    • Working Cell Bank (WCB)

 

Upstream process development

  • Batch, fed-batch, perfusion
  • Parallel cultivation systems
  • Process optimization
  • Lab to production scale
  • Scale-up and scale-down studies

 

Downstream process development

  • Chromatography and filtration
  • HCP and DNA removal
  • Scale-up and scale-down studies

Certified GMP production

  • State-of-the-Art production sites
  • Process development and validation
  • Clinical supply up to Phase III
  • Commercial supply
  • Art works and secondary packing

Formulation development

  • Screening and development of liquid, semi-solid and solid formulations

    • Protein unfolding (HT-┬ÁDSC
    • Protein structure (FT-IR, CD)
    • Protein aggregation (DLS, LO)

  • Manufacture of stability and preclinical batches
  • Scale-up and industrial transfer
  • Primary packaging development

Analytics and Quality Control

  • Characterization and method development
  • GLP/GMP-compliant studies
  • In-process-control
  • Release testing
  • Stability testing according to international guidelines  (e.g. ICH)

 

Regulatory Services

  • Preparation of registration documentation
  • Support of registration processes (worldwide)
  • Regulatory consulting services from early development to registration
  • Strategic advice
  • Project management
  • Lifecycle management/maintenance for existing products

 

Covering the entire Value Chain

Nordmark Biotech provides the complete value chain and the full range of services to meet your drug development needs all the way through to commercialization.

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Contact

Nordmark Biotech
Dr. Jan Heyland
Pinnauallee 4
25436 Uetersen
T +49 (0) 4122 712 907
F +49 (0) 4122 712 545
projects(at)nordmark-biotech.de