Rapid and adaptable evaluation of monoclonal antibody therapeutics using the Fc receptor panel test based on Octet System before selection of the final molecule.
The Octet system optimises itself for each new mAb, optimising the buffer and background conditions, thus minimising any non-specific interactions that might occur. Once this is done, it is necessary to optimise the association and dissociation times of the receptors with that antibody.
Accuracy and optimisation are the points required before arriving at the GMP test.
This system is fully compliant with CFR Part 11, and can easily be used for the Fc receptive panel test as a quantitative system, which is like a variant of ELISA (Enzyme-linked Immunosorbent Assay)