Fcγ Receptor and Antigen Kinetic Screening for Rapid Biosimilar Downstream Processing Assessment Using Octet® BLI

Last updated: June 29, 2023


Demonstrating biosimilarity throughout upstream and downstream production processes is crucial. However, screening all potential candidates using standard analytical methods can be challenging. To overcome this, an alternative high-throughput analytical approach is needed. In this application note, we showcase the ability to rapidly test a Humira® biosimilar (adalimumab) development sample against three key ligands, meeting regulatory requirements.

Our approach involves combining a single analyte kinetic screen of a monoclonal IgG1 antibody against the Fcγ receptors CD16a V176 and CD64, along with the antigen TNFα. This enables the rapid assessment of column elution fractions of a biosimilar under development. Moreover, this process can be easily adapted to assess multiple Critical Quality Attributes (CQAs) and requires only small amounts of protein.

By combining kinetic screening with the high-throughput capabilities of the Octet® Bio-Layer Interferometry platform, we can achieve a straightforward orthogonal approach. This allows for the rapid assessment of multiple attributes, such as Fcγ receptor binding and glycan screening, directly from supernatants with or without purification.

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Key Takeaways

This application note covers:

  • How to rapidly assess column elution fractions of a biosimilar under development
  • Kinetic Screening – Analyte Response Optimization
  • Kinetic Screen Qualification – Repeatability
  • Kinetic Screen – Biosimilar Assessment
  • The single analyte concentration kinetic screens approach allows multiple attributes and CQAs to be rapidly assessed in a single assay enabling users to triage molecules with desired characteristics so that only optimal ones are progressed downstream

  • Document type: Application Note
  • Page count: 18
  • Read time: 30 minutes

Octet® BLI Systems Are Used Throughout Process Development

Figure 1. Octet® BLI systems can be used at multiple points upstream and downstream to assess several key attributes including target binding characterization. Octet® BLI Biosensors and kits allow users to use multiple assay formats and to assess and analyze a wide range of biological information.

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