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Biotechnology: Safety Assessment of Biotherapeutics and Agribiotechnology-Derived Foods

Toxicology of Specific Groups of Substances

  1. John A. Thomas PhD, FATS

Published Online: 15 DEC 2009

DOI: 10.1002/9780470744307.gat154

General, Applied and Systems Toxicology

General, Applied and Systems Toxicology

How to Cite

Thomas, J. A. 2009. Biotechnology: Safety Assessment of Biotherapeutics and Agribiotechnology-Derived Foods. General, Applied and Systems Toxicology. .

Author Information

  1. Indiana University, Department of Pharmacology and Toxicology, School of Medicine, Indianapolis, Indiana, USA

Publication History

  1. Published Online: 15 DEC 2009

Abstract

The advent of recombinant DNA (rDNA) technologies has accelerated progress in developing large proteinaceous molecules with therapeutic properties. Such development has resulted in alternative sources for hormones (e.g. insulin, growth hormone), for immunomodulators, selected neurological disease therapies and for human monoclonal antibodies (Mab). Not only have advances occurred in human therapies, but considerable progress has been made in designing genetically modified (GM) food crops(e.g. soy beans, corn, etc.) that require the use of less chemical herbicides, can be grown with high yields, and are often more nutritious.

These advances in rDNA have provided both medicine and agriculture with new avenues for therapeutic agents and food crops. Many of the safety evaluation protocols involving rDNA products necessitate a battery of pre-clinical tests that include protein allergenicity and immunotoxicity, genotoxicity, and other specific assays.

Keywords:

  • biotherapeutics;
  • rDNA technologies mabs;
  • antisense drugs;
  • agribiotechnology;
  • GM foods;
  • herbicide tolerance;
  • plant-derived vaccines