High-Throughput Biosimilarity Assessment with Octet® BLI Systems

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.

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