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Bioanalytics and Characterisation

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

Assay

Quantitation

  • Absorbance at 280 nm

  • Slope spectrometry

  • Surface plasmon resonance (SPR)

  • 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 (SPR)

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 CE-SDS)

Process-related Impurities

  • qPCR and kit-based residual testing

    • DNA

    • HCP

    • Protein A

Activity/Potency

  • Colorimetric, kinetic or enzymatic assays

  • Binding ELISA & ligand interactions (SPR)

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Safety

  • Endotoxin

  • Bioburden*

  • Sterility*

* Outsourced assays

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