WHO Expert Committee on Biological Standardization
Forty-eighth Report
Technical Report Series, No 889
World Health Organization
ISBN-13    9789241208895 ISBN-10    9241208899
Order Number    11000889
Price    CHF    23.00 / US$    27.60 Developing countries:    CHF    16.10
English     1999        117   pages
Presents the recommendations of a WHO expert committee commissioned to coordinate a range of research and other activities needed to assure the purity, potency, safety, and stability of biological products used in medicine. The report has four parts. The first provides a brief discussion of general issues that shape the committee's work. Issues discussed include progress in the establishment of cytokine standards, efforts to harmonize technical requirements for vaccine production and licensing, the implications for vaccine requirements of the Agreement on Technical Barriers to Trade of the WTO, and safety questions arising from the detection by very sensitive polymerase-chain-reaction-based methods of low levels of reverse transcriptase activity in live viral vaccines prepared in chicken cells.
The second part provides a brief review of the status of some 15 international guidelines, requirements, and related documents relevant to the manufacture and quality control of biologicals. Part three summarizes activities relating to the status and development of biological reference materials for various antibodies, antibiotics, blood products and related substances, cytokines and growth factors, and other substances.
The fourth and most extensive part issues detailed guidelines for the production and control of synthetic peptide vaccines, requirements for tick-borne encephalitis vaccine (inactivated), and guidelines for thromboplastins and plasma used to control oral anticoagulant therapy. Also included are an amendment to the requirements for hepatitis B vaccine made by recombinant DNA techniques, and a report on the standardization and calibration of cytokine immunoassays.