Can the immunogenic profiles of Thrombin-JMI® and the human and recombinant thrombins be compared?
No, not easily. A range of antibody assays are available, each with its own advantages and disadvantages.27 However, it is impractical to compare immunogenicity results between laboratory sites or clinical studies because of lack of standardization and validation of assay procedures and data representation used to assess and demonstrate the immune response to a biopharmaceutical.17,27 Overall, the level of antibody response may not be as important as the type of antibodies produced.24 If the antibody cannot alter the efficacy of the product or produce clinical sequelae, the impact of the antibody is diminished. Yet some information can be analyzed from head-to-head trials with Thrombin-JMI®.
