Analytics & Bioassays

Extensive bioanalytical and bioassay toolbox to ensure biosimilarity

Bioanalytics

We can establish and qualify physico-chemical and bioanalytical methods to fully characterize relevant target protein quality attributes, including in-depth analysis of post-translational modifications to match them to the originator.

  • Extensive experience in (e.g. mass spectrometry-based) analysis of complex proteins including mAbs
    • Peptide mapping, including full sequencing (UPLC-MS/MS)
    • Intact protein and semi-intact protein mass spectrometry (UPLC-MS/MS)
    • N-terminal and C-terminal protein sequencing (UPLC-MS/MS)
    • Deamidation, oxidation, pyro-glu (UPLC-MS/MS)
    • Determination of disulfide bonds (heterogeneity) (UPLC-MS/MS)
    • Released Glycans (UPLC-FLR-MS)
    • Determination of charge variants by Cation (CEX) and Anion (AEX)
    • Exchange Chromatography & by cIEF isoelectric focusing
    • Determination of aggregates and fragments by Size Exclusion
    • Chromatography (UPLC-SEC)
    • CE-SDS capillary electrophoresis
  • Determination of (CHO-based) Host Cell Proteins
  • High throughput mAb sample purification and sample analysis
  • Method qualification and validation
  • Technology transfer

Bioassays

We have also developed a toolbox of bioassays especially designed for comparing biosimilar activity to originators. These include:

  • Soluble Binding (ELISA)
  • Potency assay
  • Membrane bound antigen binding (FACS) on living cells
  • Classical ADCC assay using our proprietary affector cell line
  • CDC assay
  • FcgR Binding (CD16V, CD16F, CD32, CD64 and FcRn) on living cells

Our analytical and bioassay services are designed to support our partners development projects to ensure the quality and purity of their therapeutics. However we will support any standalone project so we can accelerate your product to patients.

Biosimilars

Cell Line Development

We take a different approach to other companies when developing biosimilar cell lines, we focus on delivering high titer cell lines and then tailoring modulation to match the given quality target product profile.

Biosimilars

Biosimilar Cell Lines

Ready to go, high expressing manufacturing biosimilar cell lines ready for development. Includes fusion proteins, enzymes and monoclonal antibodies which are available for out-licensing.

Biosimilars

Process Development

Our biosimilar process development focuses on quality and reducing cost. We know that it is critical to reduce overall cost of goods and the way we design our processes increases titer without increasing media and feed requirements.

Biosimilars

Manufacturing

We provide Drug Substance and Drug Product manufacturing for clinical and commercial supply at our cGMP facilities, including fill & finish.