Consideration of the Proteins and Peptides Produced by New Technology for use as Therapeutics

  • Darrell T. Liu
  • Neil Goldman
  • Frederick GatesIII
Part of the NATO ASI Series book series (NSSA, volume 125)

Abstract

Proteins and peptides for use as therapeutics may be isolated and purified from appropriate natural sources, prepared by rDNA technology or chemically synthesized. In this report we shall address mainly our experiences in considering production, purification, and testing of biologicals derived from rDNA technology and briefly review available documents that relate to products produced by chemical synthesis. Regardless of the source of the proteins and peptides, ultimately it is the responsibility of the manufacturers to demonstrate consistency in the safety, potency, efficacy, and purity of their products.

Keywords

Synthetic Peptide Cell Substrate Continuous Cell Line Single Chained Protein Master Cell Bank 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer Science+Business Media New York 1986

Authors and Affiliations

  • Darrell T. Liu
    • 1
  • Neil Goldman
    • 1
  • Frederick GatesIII
    • 1
  1. 1.Division of Biochemistry and BiophysicsOffice of Biologics Research and Review, CDB, FDABethesdaUSA

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