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Our Capabilities

Analytical Testing Capabilities

A deep expertise in protein analytics is a differentiating capability for protein production and this understanding of protein characterisation and impact of critical quality attributes is essential for building value in programs from research reagents through to therapeutics development. Below are a summary of assays used by the NBF.

Analysis

Structural Assessment

Assay

  • Primary sequence verification (Mass spectrometry accessed*)

  • Secondary structure (FTIR, CD and disulphide analysis) 

       Efficiency of conjugation

Quantitation

  • Absorbance at 280 nm

  • Slope spectrometry

  • Surface plasmon resonance bioloayer interforometry

  • Analytical Protein A titer measurement

Purity

  • Size-exclusion UPLC

  • Mass Photometry

  • CE-SDS

  • SDS-PAGE

Appearance

  • Appearance (colour/clarity)

  • Particulates (visual and sub-visual)

  • Osmolality & pH

Identity 

  • SDS PAGE

  • Western blot

  • CE-SDS

  • Peptide mass fingerprinting

  • Binding kinetics by surface plasmon resonance

Product Purity and Impurity

  • Aggregation profile (CE-SDS, SE-UPLC)

  • Charge variants (cIEF or CEX)

  • Fragmentation (SDS-PAGE gels, rp-HPLC)

  • Size variants (reducing & non-reducing E-SDS)

  • Post translation modifications: Oxidation, Deamidation, glycosylation (mass spectrometry* and other relevant techniques)

Process-related Impurities

  • qPCR and kit-based / process-specific Residuals: metal ions, DNA, HCPs, Protein A, Selection agents, Antifoam, PS-80 etc.

Activity/Potency

  • Colorimetric, kinetic or enzymatic assays

  • Binding ELISA & ligand interactions (BLI/SPR)

  • Cell based bioassays

  • Effector function – ADCC and CDC

Glycosylation Profiling

  • Glycan complexity:

  • Deglycosylation coupled with CE separation

  • Heterogeneity (cIEF)

  • Glycan occupancy

Safety

  • Endotoxin levels

  • Mycoplasma contamination

  • Bioburden

  • Sterility