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
- Post-translational modifications analysis
- Glygosylation, sulfation, phosphorylation, hydroxylation, deamidation, acetylation, oxidation, carbamylation and gamma-carboxylation
- 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
- Formulation assessment
