Development of Rabbit Monoclonal Antibodies for Quantitation of Therapeutic Human Antibodies in Preclinical Non-Human Primate Studies
Posted by Adam Awdish on
Innovative Grade US Origin Monkey Cynomolgus Serum from Innovative Research was used in the following study:
Ruiyin Chu, Jacob Gerstein, Hai Wu, Haibin Huang, Yang Lou, and Rachel Palmer
Monoclonal Antibodies in Immunodiagnosis and Immunotherapy
October 21, 2020
In recent years, therapeutic monoclonal antibodies (mAbs) have become one of the fastest growing drug classes approved for the treatment of a wide range of indications. Preclinical characterization of these therapeutic mAbs often must be performed in non-human primates to prove their safety and efficacy before the initiation of clinical human studies.
The cynomolgus monkey is a common primate for preclinical studies with therapeutic antibodies, as it often provides a sufficient level of cross reactivity with the target of the antibody. Unfortunately, the immunoglobulins (IgGs) of cynomolgus monkeys also show a high sequence homology with the IgGs of humans, which creates a significant challenge for the analytical measurement of human therapeutic antibodies in non-human primate serum samples. mAbs have traditionally been generated in mice, however, the use of rabbit mAbs has increased in recent years.
Rabbit mAbs offer several advantages over mouse mAbs, such as higher affinity and specificity, along with more diverse epitope recognition than mouse antibodies. Researchers in this study took advantage of the latest rabbit B cell cloning technology to develop six unique antihuman IgG mAb clones.
Researchers immunized rabbits with human IgGs. Each of the rabbit anti-hIgG mAb clones were evaluated by assays and found to be suitable for use as capture reagent in generic pharmacokinetic assays in the presence of cynomolgus monkey serum. They may be used alone or as pairs for the detection of human IgG to meet the need for therapeutic mAb development in preclinical studies.
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Pooled Human Serum Off The Clot