Drug Development of Therapeutic Monoclonal Antibodies

Diane R. Mould, Bernd Meibohm

Research output: Contribution to journalReview article

26 Citations (Scopus)

Abstract

Monoclonal antibodies (MAbs) have become a substantial part of many pharmaceutical company portfolios. However, the development process of MAbs for clinical use is quite different than for small-molecule drugs. MAb development programs require careful interdisciplinary evaluations to ensure the pharmacology of both the MAb and the target antigen are well-understood. Selection of appropriate preclinical species must be carefully considered and the potential development of anti-drug antibodies (ADA) during these early studies can limit the value and complicate the performance and possible duration of preclinical studies. In human studies, many of the typical pharmacology studies such as renal or hepatic impairment evaluations may not be needed but the pharmacokinetics and pharmacodynamics of these agents is complex, often necessitating more comprehensive evaluation of clinical data and more complex bioanalytical assays than might be used for small molecules. This paper outlines concerns and strategies for development of MAbs from the early in vitro assessments needed through preclinical and clinical development. This review focuses on how to develop, submit, and comply with regulatory requirements for MAb therapeutics.

Original languageEnglish (US)
Pages (from-to)275-293
Number of pages19
JournalBioDrugs
Volume30
Issue number4
DOIs
StatePublished - Aug 1 2016

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Monoclonal Antibodies
Pharmaceutical Preparations
Pharmacology
Anti-Idiotypic Antibodies
Therapeutics
Pharmacokinetics
Kidney
Antigens
Liver
In Vitro Techniques

All Science Journal Classification (ASJC) codes

  • Biotechnology
  • Pharmacology
  • Pharmacology (medical)

Cite this

Drug Development of Therapeutic Monoclonal Antibodies. / Mould, Diane R.; Meibohm, Bernd.

In: BioDrugs, Vol. 30, No. 4, 01.08.2016, p. 275-293.

Research output: Contribution to journalReview article

Mould, Diane R. ; Meibohm, Bernd. / Drug Development of Therapeutic Monoclonal Antibodies. In: BioDrugs. 2016 ; Vol. 30, No. 4. pp. 275-293.
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