As part of the immunogenicity assessment, it is required to evaluate formation of neutralizing antibodies (NAb) for both the biosimilar and originator . The NAb pose a significant risk for loss of treatment efficacy and potential inhibition of endogenous protein function. Differences in formulation, packaging and other subtle variations during manufacturing process could give rise to immunogenic potential of a biosimilar.
Ingenuity has custom cell line, positive controls and other reagents that are necessary for the development of robust Nab assays. We utilize cell-based methods based on the drug’s mechanism of actions such as cell proliferation, cell viability, cell signaling, receptor activation etc. to develop and validate Nab assays. In addition to cell-based methods, we also have developed innovative ligand binding methods for the evaluation of neutralizing antibodies that has been accepted by global regulatory authorities.
Our scientists have extensive experience and expertise in developing immunoassays in various platforms for the assessment of neutralizing antibodies. In addition to our pre-validated methods, we can develop custom reagents (such as cell line, positive control etc.) and custom methods to support novel biologics development.
Click on the link below to find some examples of the pre-validated biosimilar pharmacokinetic methods.