App Note: Kinetic screening for rapid biosimilar testing

Medical researcher

A new App Note is now available for download entitled ‘Fcγ Receptor and Antigen Kinetic Screening for Rapid Biosimilar Downstream Processing Assessment’.

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.

Download now.

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