Annals of Clinical Trials and Vaccines Research

Monoclonal Antibody Quality:

 The potential role of antibodies (Abs) in the treatment of diseases dates back to the end of 1800, when the German physiologist Emil Adolf von Behring discovered that small amounts of diphtheria toxins were able to immunize animals against the pathology . However, Emil Adolf von Behring did not attribute this propriety to Abs and several years were necessary to well understand their role, structure, and potentiality. With the large-scale monoclonal Ab (mAb) production started with the hybridoma technique, mAbs have become one of the most popular drug candidates. The first mAb approved by the United States Food and Drug Administration (FDA) was the Muromonab-CD3 in 1986, while the first fully human mAb (adalimumab) was approved in 2002 for the treatment of rheumatoid arthritis. mAbs are not only a therapeutic instrument, but represent one of the most commonly used tools in laboratory research, being at the basis of many techniques and approaches (e.g., Western blot, immunochemistry, flow cytometry, immunoprecipitation, ELISA). It is clear that more and more interests are growing around mAbs and their potential use. In this framework, processes related to mAbs development, production, and distribution need to be controlled and reproducible. Mass spectrometry (MS) represents one of the most powerful tools to analyze high complex molecules as mAbs. With high reproducibility, specificity, sensitivity and high-throughput features, MS has become a very used technique in the mAbs research field. For example, Arboleda-Velasquez JF et al verified the identity of the ApoE3 monoclonal antibody 1343A before its usage. This review focus on principal quality issues in mAbs research and some MS-based methods useful to check the quality and to quantify mAbs batches during their development and commercial production.  

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