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Interferon immunogenicity: technical evaluation of interferon-alpha 2a

E Hochuli1

  • 1Department of Biotech Production and Process Development, F. Hoffmann-La Roche Ltd., Basel, Switzerland, USA.

Journal of Interferon & Cytokine Research : the Official Journal of the International Society for Interferon and Cytokine Research
|July 1, 1997
PubMed
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Patient antibody responses to interferon-alpha 2a (IFN-alpha 2a) were investigated. Storage temperature significantly impacts IFN-alpha 2a immunogenicity, with refrigerated storage (2-8°C) recommended to minimize antibody formation.

Area of Science:

  • Biochemistry
  • Immunology
  • Pharmaceutical Science

Background:

  • Neutralizing antibodies to interferon-alpha 2a (IFN-alpha 2a) have been observed in patients.
  • The immunogenicity of therapeutic proteins can be influenced by their formulation and storage conditions.

Purpose of the Study:

  • To investigate the cause of antibody production against IFN-alpha 2a.
  • To evaluate the impact of production and storage conditions on IFN-alpha 2a immunogenicity.

Main Methods:

  • Analysis of IFN-alpha 2a vial contents for aggregates, including interferon-interferon (IFN-IFN) and interferon-human serum albumin (IFN-HSA) aggregates.
  • Assessment of aggregate formation under different storage temperatures (4°C vs. ambient).
  • Evaluation of the relative immunogenicity of IFN-alpha 2a stored under varying conditions.

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Main Results:

  • IFN-IFN and IFN-HSA aggregates were detected in IFN-alpha 2a vials.
  • Aggregate formation was temperature-dependent, increasing significantly at ambient temperatures compared to 4°C.
  • The immunogenicity of IFN-alpha 2a increased with storage at ambient temperature but not at 4°C.

Conclusions:

  • The immunogenicity of IFN-alpha 2a is closely linked to its storage temperature.
  • Refrigerated storage (2-8°C) is recommended to minimize aggregate formation and subsequent antibody response.
  • A new HSA-free formulation eliminates the risk of IFN-HSA aggregation.