Protocol: PK Bridging ELISA Detecting Total Drug Using Anti-Tocilizumab Antibodies
Pharmacokinetic (PK) Bridging ELISA detects total drug (free and partially bound): For Use with Anti-Tocilizumab Monoclonal Antibodies HCA252 and HCA257P
This method provides a procedure for carrying out a PK ELISA with Anti-Tocilizumab Antibodies HCA252 (capture antibody) and HCA257P (detection antibody), and using tocilizumab for the standard curve.
Anti-Tocilizumab Antibody HCA252 is an inhibitory antibody. Anti-Tocilizumab Antibody HCA257P is a non-inhibitory antibody that does not inhibit the binding of tocilizumab to its target Interleukin 6 Receptor (IL-6R). This combination enables measurement of free and partially bound tocilizumab, which is equivalent to total drug when trough serum levels are above 10 µg/ml. The method should always be used in conjunction with product and batch specific information provided with each vial (see product datasheets). This protocol will need to be adjusted for use with different detection methods and immunoassay technology platforms.
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