Protein Characterization and Testing

Protein Characterization
& Testing

Haemtech Biopharma can run a myriad of analytical techniques to provide a biochemical analysis of your proteinaceous drug product or substance or to assist with contaminant identification. Our menu of assays, tests and techniques are:

Applications

  • Thrombogenicity of IVIG drug products
    • In process impurity analysis
  • Anti-drug antibody testing (immunogenicity) related to hemostasis
    • e.g. anti-clotting factor antibodies
  • Host cell protein identification, quantitation and mitigation
    • In process and in drug product
  • Stability and release testing of drug products
  • Potency and purity determination of recombinant proteins related to hemostasis
  • Plasma protein analysis
  • Structural characterization of proteins
    • Post-translational modifications
    • Disulfide bond mapping
    • Conformational changes
  • Characterization of coagulation assay reagents (e.g. thromboplastin)
  • Custom assay applications for coagulation products
  • Pharmacokinetic studies
  • Assay qualification/validation
  • Process/product validation
  • Protein purification method development
  • Forced degradation studies

Methods

  • HPLC
    • Reverse phase (RPC)
    • Size exclusion (SEC)
    • Ion exchange (IEC)
    • Hydrophobic interaction (HIC)
    • Metal affinity (IMAC)
    • Protein A (for IVIG analysis)
  • SDS-PAGE
    • Reducing and non-reducing
    • 1D and 2D
    • Coomassie blue staining
    • Silver staining
    • Fluorescent staining
    • Western blot
    • Multi-plexed analysis
    • Quantitation
  • Clotting assays
    • Factor assays (II, V, VII, VIII, IX, X, XI, XII, XIII, etc)
    • PT
    • aPTT
    • NAPTT
    • Holmes test
    • Other
  • ELISA
    • Various
  • Chromogenic assays
    • Factor assays (II, V, VII, VIII, IX, X, XI, XII, XIII, etc)
    • Other
  • Thrombin generation assays
    • For IVIG and other
  • Anti-drug antibody ELISAs (ADA)
    • Antibodies against drug substance
    • Antibodies against host cell proteins
    • Antibodies against contaminants or break-down products
  • Identification of unknowns
    • Mass spec
    • N-terminal sequencing
  • Residual moisture determination
  • Head-space vacuum measurement
  • pH
  • Osmolality
  • Refractive index
  • Total protein
  • Post-translational modification analysis
    • Glycosylation, sulfation, phophorylation, hydroxylation, deamidation, acetylation, oxidation, carbamylation and gamma-carboxylation
  • Formulation assessment

Contact Us

Please contact Haemtech using the form below for more information.

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