Procedures for Stabilization of Interferons

  • Sedmak J
  • Jameson P
  • Grossberg S
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Abstract

This chapter discusses the procedures for stabilization of interferons. The stability of interferons, especially as they are processed and purified, has proved to be a greater problem than is appreciated from early observations on the stability of crude materials. It is now realized that interferons in solution can be inactivated by a variety of physical and chemical treatments, but a degree of stability can be provided by means of certain additives. For long-term storage of interferon preparations, particularly those intended for clinical use, freeze-drying is preferred. One of the most effective methods of preserving interferon activity for extended periods, such as storage of reference reagents or preparations for clinical use, is freeze-drying in the presence of low concentrations of added protein and a sodium phosphate buffer. Two accelerated storage tests are used to predict the stability of freeze-dried interferons. The accelerated multiple isothermal stability test is used to provide a conservative estimate of the expected stability of these standards under long-term storage conditions. © 1981, Elsevier Inc. All rights reserved.

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Authors

  • J. James Sedmak

  • Patricia Jameson

  • Sidney E. Grossberg

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