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WHO Expert Committee on Biological Standardization.

B Horowitz, P Minor, J J Morgenthaler

    World Health Organization Technical Report Series
    |February 8, 2005
    PubMed
    Summary
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    This WHO report details international standards for vaccine production and biological reference materials. It offers guidance on quality control for specific vaccines and viral safety in blood products.

    Area of Science:

    • Biotechnology and Pharmaceutical Sciences
    • Immunology and Infectious Diseases
    • Regulatory Science

    Background:

    • The World Health Organization (WHO) Expert Committee convenes to harmonize global standards for biological products.
    • International biological reference materials are crucial for consistent vaccine and therapeutic production.
    • Evolving scientific understanding necessitates updated guidelines for biological product control.

    Purpose of the Study:

    • To present recommendations for international requirements in the production and control of vaccines and biologicals.
    • To outline the development and status of international biological reference materials.
    • To provide specific guidelines for manufacturers and regulatory authorities on vaccine quality and safety.

    Main Methods:

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  • The committee reviewed general issues and the status of various biological reference materials.
  • Recommendations were formulated based on expert consensus and scientific evidence.
  • Specific guidelines were developed for meningococcal C conjugate vaccines, oral cholera vaccines, and viral safety procedures.

    • Main Results:

    • Established the status and development of reference materials for antibodies, antigens, blood products, cytokines, growth factors, and endocrinological substances.
    • Provided detailed recommendations for the production and quality control of meningococcal group C conjugate vaccines.
    • Issued guidelines for the production and quality control of inactivated oral cholera vaccines.
    • Presented guidelines on viral inactivation and removal procedures for blood plasma products.

    Conclusions:

    • The report facilitates the adoption of unified international standards for biological product manufacturing and control.
    • Recommendations support enhanced quality, safety, and efficacy of vaccines and biologicals globally.
    • The established reference materials and guidelines aid national regulatory authorities and manufacturers in ensuring product integrity.