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Biopharmaceutical characterization
We have extensive experience in the characterization of drugs and biopharmaceuticals, including therapeutic antibodies, proteins, and peptides. In addition, we characterize non-biological complex drugs (NBCD) and dendrimeric nanoparticles.
Technique
SDS-PAGE
Hardware
NA
Method
Identity
Description
Identification of an analyte based on its molecular size and its electrophoretic pattern.
Purity
Determination of the abundance of an analyte based on its relative percentage.
Content
Quantitation of an analyte based on the optical density of an albumin standard.
Technique
Protein Thermal Shift
Hardware
7500 Fast Real-Time PCR system (Thermo Fisher Scientific)
Method
Average melting temperature (Tm)
Description
Determination of the structural stability of a protein based on its Tm by extrinsic fluorescence.
Technique
UV/Vis
Hardware
Epoch® Spectrophotometer (BioTek Instruments)
Method
Content
Description
Determination of the protein content of a sample based on its UV absorbance.
Technique
Osmolarity
Hardware
Advanced (Instruments Inc.)
Method
Osmolarity
Description
Determination of the osmotic concentration of solutes in a sample.
Technique
UV-Vis Chromatografic
Hardware
Acquity® Class H Liquid Chromatograph (Waters)
Method
Molecular Size
Description
Identification of the size of a protein based on its elution in a molecular exclusion system and a molecular size standard.
Hydrophobicity profile
Separation of the protein components of a sample based on its retention time in a reversed-phase system.
Acid and basic isoforms
Separation of the acidic and basic variants of protein sample using a cation exchange system.
Affinity
Quantitation of a mAb in a sample using a Bond-Elute system with Protein A.
Technique
MS/MS Chromatography
Hardware
Vion® Hybrid Mass Spectrometer (ESI-IMS-Q-ToF) coupled to an Acquity® Class I (Waters) system
Method
Intact Mass
Description
Direct determination of the exact mass of an analyte.
Reduced Mass
Determination of the exact mass of the subunits of a protein subjected to reducing conditions.
Peptide Mapping
Corroboration of the primary structure of a therapeutic protein, reduced or not reduced, subjected to an enzymatic digestion process.
Glycan profiling
Identification of the carbohydrates bonded to a therapeutic protein using an N-glycosidase.
Technique
Surface Resonance of Plasmons
Hardware
Biacore T200 (GE)
Method
Affinity
Description
Determination of the antibody-antigen affinity constant by plasmon surface resonance.
