Literature DB >> 25681157

The development of therapeutic monoclonal antibodies: overview of the nonclinical safety assessment.

Janice A Lansita1, Barbara Mounho-Zamora.   

Abstract

Monoclonal antibodies (mAbs) represent a class of biotechnology-derived therapeutics for use in the treatment of various disease indications such as oncology, autoimmune, cardiovascular, and metabolic disorders. Monoclonal antibodies are immunoglobulin (Ig) proteins engineered to bind to specific antigens with high specificity. The concepts reviewed in this paper include 1) the regulatory procedures and guidelines that apply to mAbs, 2) the types of toxicology studies applicable to mAbs, and 3) the scientific challenges, such as the selection of a relevant animal species and the development of anti-drug antibodies, that can arise due to the unique properties of mAbs.

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Year:  2015        PMID： 25681157     DOI： 10.1007/s11916-014-0472-x

Source DB:  PubMed          Journal:  Curr Pain Headache Rep        ISSN： 1534-3081


  23 in total

Review 1.  Structure and function of immunoglobulins.

Authors:  Harry W Schroeder; Lisa Cavacini
Journal:  J Allergy Clin Immunol       Date:  2010-02       Impact factor: 10.793

Review 2.  Engineering therapeutic monoclonal antibodies.

Authors:  Xiao-yun Liu; Laurentiu M Pop; Ellen S Vitetta
Journal:  Immunol Rev       Date:  2008-04       Impact factor: 12.988

3.  Maturing antibody-drug conjugate pipeline hits 30.

Authors:  Asher Mullard
Journal:  Nat Rev Drug Discov       Date:  2013-05       Impact factor: 84.694

4.  Prediction of human pharmacokinetics of therapeutic monoclonal antibodies from simple allometry of monkey data.

Authors:  Masataka Oitate; Noriko Masubuchi; Takashi Ito; Yoshiyuki Yabe; Tsuyoshi Karibe; Takanori Aoki; Nobuyuki Murayama; Atsushi Kurihara; Noriko Okudaira; Takashi Izumi
Journal:  Drug Metab Pharmacokinet       Date:  2011-05-24       Impact factor: 3.614

5.  Placental transfer of Fc-containing biopharmaceuticals across species, an industry survey analysis.

Authors:  Christopher J Bowman; William J Breslin; Anu V Connor; Pauline L Martin; Graeme J Moffat; Lakshmi Sivaraman; M Belen Tornesi; Simon Chivers
Journal:  Birth Defects Res B Dev Reprod Toxicol       Date:  2014-01-03

Review 6.  Development trends for monoclonal antibody cancer therapeutics.

Authors:  Janice M Reichert; Viia E Valge-Archer
Journal:  Nat Rev Drug Discov       Date:  2007-05       Impact factor: 84.694

7.  Toxicopathology of the developing immune system: investigative and development strategies.

Authors:  Daniel Weinstock; David B Lewis; George A Parker; Joseph Beyer; Mark Collinge; Thomas P Brown; Noel Dybdal
Journal:  Toxicol Pathol       Date:  2010-10-20       Impact factor: 1.902

8.  Neonatal Fc receptor mediates internalization of Fc in transfected human endothelial cells.

Authors:  Nancy A Goebl; Clifford M Babbey; Amita Datta-Mannan; Derrick R Witcher; Victor J Wroblewski; Kenneth W Dunn
Journal:  Mol Biol Cell       Date:  2008-10-08       Impact factor: 4.138

9.  A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults.

Authors:  Gabriel J Robbie; Ryan Criste; William F Dall'acqua; Kathryn Jensen; Nita K Patel; Genevieve A Losonsky; M Pamela Griffin
Journal:  Antimicrob Agents Chemother       Date:  2013-09-30       Impact factor: 5.191

10.  Marketed therapeutic antibodies compendium.

Authors:  Janice M Reichert
Journal:  MAbs       Date:  2012-04-26       Impact factor: 5.857
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  1 in total

1.  Headache symptom modification: the relevance of appropriate manual therapy assessment and management of a patient with features of migraine and cervicogenic headache - a case report.

Authors:  Kiran Satpute; Nilima Bedekar; Toby Hall
Journal:  J Man Manip Ther       Date:  2019-09-20
  1 in total

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