Fcγ Receptor and Antigen Kinetic Screening for Rapid Biosimilar Downstream Processing Assessment

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Demonstrating similarity of biomolecules such as antibodies throughout upstream and downstream production processes is crucial. A rapid testing method is demonstrated using a Humira biosimilar (adalimumab) development sample, which assesses compatibility with three essential ligands in compliance with regulatory standards.

This Application Note covers:

  • How to rapidly assess column elution fractions of a biosimilar under development
  • Kinetic screening for analyte response optimisation
  • Repeatability of kinetic screen qualification
  • Biosimilar assessment in terms of kinetic binding

The single analyte concentration screening approach allows multiple attributes and critical quality attributes (CQAs) to be rapidly assessed in a single assay. This enables users to triage molecules with desired characteristics so that only optimal biosimilars are progressed downstream.

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