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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
