Our testing capabilities

Biological Molecule Solutions

Biological molecules—encompassing therapeutic proteins, monoclonal antibodies (mAbs) and its derivatives— are at the frontier of modern precision medicine. Investigated for their transformative potential for treatment across various therapeutic areas, such as autoimmune diseasess, oncology, and metabolic disorders, these protein-based modalities require sophisticated manufacturing and rigorous characterization. Due to their inherent complexity and sensitivity to environmental conditions, they demand a comprehensive set of analytical approaches to ensure stability, safety, and clinical efficacy.

Our biological molecule track record:

  • Antibodies & derivatives, e.g. ADC, sdAb, multi-specifics
  • Biosimilars
  • Therapeutic proteins e.g. enzymes
  • Radiotherapeutics
  • Vaccines

Advance your biological molecule with analytical confidence. 

Meet our scientists


Testing capabilities


General quality

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

Identity & purity

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

Process impurities & contaminants

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

Quantity

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

Impurities

  • Degradation
  • Physical / Chemical modifications

Potency

  • Immuno assays
  • Enzymatic assays
  • Cell-based assays

Key technologies

  • Karl Fischer titration
  • Viscosity
  • Density
  • Osmometry
  • Spectophotometry
  • Liquid Chromatography
  • Gas Chromatography
  • Real-time PCR (RT-qPCR)
  • Luminescence/Fluorescence
  • ELISA
  • Gel Electrophoresis
  • Chip Electrophoresis
  • Capillary Electrophoresis
  • Light Obscuration
  • Laser Diffraction
  • Dynamic Light Scattering
  • Flow Imaging Analysis
  • Mass Spectrometry
    • LC-MS, Triple Quad
    • LC-MS, High Resolution

All testing capabilities


Synthetic Molecule Solutions

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Biological Molecule Solutions

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Cell & Gene Therapy solutions

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