Anacura

Experience

  • Monoclonal antibodies (incl. second generation, e.g. fragments, bispecifics)
  • Antibody-drug conjugates (ADCs)
  • Proteins (e.g. enzymes)
  • Vaccines 
  • Oligonucleotides

Analytical solutions

  • Lead selection
  • Forced degradation
  • Method development & optimization
  • Method validation
  • Method transfer
  • Release & stability (ICH, in-use, cyclic stress)
  • Comparability
  • Troubleshooting
  • Consultancy

Testing capabilities

Identity & purity

  • Molecular weight
  • Size distribution
  • Charge variants
  • Glycosylation profile
  • Disulphide bridges
  • Drug-to-antibody ratio (DAR)

Impurities

  • Degradation
  • Physical modifications
  • Chemical modifications

Quantity

  • Total protein content
  • In matrix (serum, CSF)

Potency

  • Immunoassays
  • Enzymatic assays
  • Cell-based assays

General quality

  • Appearance
  • pH
  • Osmolality
  • Particulate matter
  • Moisture content

Process impurities & contaminants

  • Host-derived (HCPs, DNA)
  • Downstream / culture-derived
  • Residual solvents / chemicals / biochemicals / inorganic salts
  • Medium components
  • Mycoplasma
  • Sterility
  • Endotoxins

Meet our scientist