By Pamela A. Trail (auth.), Gail Lewis Phillips (eds.)
This quantity gathers the best learn on antibody-drug conjugates and immunotoxins. Following a rigorous evaluation, the quantity delves into concentrated sections on all points of ADCs and ITs from scientific improvement via to distinct healing purposes and the newest technologies.
Read or Download Antibody-Drug Conjugates and Immunotoxins: From Pre-Clinical Development to Therapeutic Applications PDF
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Extra info for Antibody-Drug Conjugates and Immunotoxins: From Pre-Clinical Development to Therapeutic Applications
It is important to point out that the DAR only refers to the average payload per antibody. Each antibody can have several different sites of conjugation, but even with improving methods, it remains difﬁcult to control where each SMD is conjugated. This leaves a high level of heterogeneity in the conjugates. Moreover, the ADC product contains a distribution of payload as well as some unconjugated antibody. 32 A. Khandelwal et al. Immunogenicity ADCs represent a classical hapten-carrier antigen, where the hapten (SMD) is not immunogenic on its own, but when conjugated to a carrier protein (mAb), animals can mount a heterogenous immune response to the hapten, including Ig class-switched, high-afﬁnity antibodies [25–28].
Earlier in the development of ADCs, researchers strove to determine the levels of each component in the investigational ADC, including the conjugate, total SMD, free SMD, total antibody, and free antibody. However, as the ﬁeld has evolved and more insight has been gained on the analytical challenges in ADC development, it has been determined that measuring all of these components may not be feasible and essential for characterization of the disposition of the ADC. Now, the most important and useful parameters stem from three key measurements in systemic circulation: intact conjugate, total antibody , and free (unbound) SMD.
Population PK analysis is extremely useful for analyzing sparse PK data collected from larger clinical studies in which intensive PK sampling may not be feasible [39, 40]. ECG Evaluation The effect of the ADC on ventricular repolarization as measured by the QT/QTc interval needs to be determined during development. While ECG monitoring has been sufﬁcient in the past for therapeutic mAbs given their low likelihood for ion 2 Antibody–Drug Conjugate Development 35 channel interactions, this may not be the case for ADCs .
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