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

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.