WHO Expert Committee on Biological Standardization
Fifty-fourth Report
Technical Report Series, No 927
World Health Organization
ISBN-13    9789241209274 ISBN-10    9241209275
Order Number    11000927 Format    E-book collection (PDF)
Price    CHF    30.00 / US$    36.00 Developing countries:    CHF    21.00
English     2005        160   pages
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Summary
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international requirements for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the Committee's attention and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national control authorities, contains recommendations for the production and quality control of inactivated influenza vaccine, recommendations for the production and quality control of pneumococcal conjugate vaccines, guidelines on regulatory expectations related to the nonclinical evaluation of vaccines, an addendum to the recommendations for production and quality control of diphtheria, tetanus and pertussis vaccines, and an addendum to the recommendations for the use of animal cells as in vitro substrates for the production of biologicals.