Biotherapeutics: Challenges and Opportunities for Predictive Toxicology of Monoclonal Antibodies.

Abstract:

:Biotherapeutics are a rapidly growing portion of the total pharmaceutical market accounting for almost one-half of recent new drug approvals. A major portion of these approvals each year are monoclonal antibodies (mAbs). During development, non-clinical pharmacology and toxicology testing of mAbs differs from that done with chemical entities since these biotherapeutics are derived from a biological source and therefore the animal models must share the same epitopes (targets) as humans to elicit a pharmacological response. Mechanisms of toxicity of mAbs are both pharmacological and non-pharmacological in nature; however, standard in silico predictive toxicological methods used in research and development of chemical entities currently do not apply to these biotherapeutics. Challenges and potential opportunities exist for new methodologies to provide a more predictive program to assess and monitor potential adverse drug reactions of mAbs for specific patients before and during clinical trials and after market approval.

journal_name

Int J Mol Sci

authors

Johnson DE

doi

10.3390/ijms19113685

subject

Has Abstract

pub_date

2018-11-21 00:00:00

issue

11

issn

1422-0067

pii

ijms19113685

journal_volume

19

pub_type

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