This record offers the options of a WHO professional Committee commissioned to coordinate actions resulting in the adoption of foreign innovations for the creation and keep watch over of vaccines and different biologicals and the institution of overseas organic reference materials.The document begins with a dialogue of common concerns delivered to the eye of the Committee and offers details at the prestige and improvement of reference fabrics for numerous antibodies, antigens, blood items and similar ingredients, cytokines, development elements, and endocrinological substances.The moment a part of the file, of specific relevance to brands and nationwide regulatory professionals, comprises directions at the construction and quality controls of candidate tetravalent dengue virus vaccines and suggestions for the guidance, characterization and institution of foreign and different organic reference criteria. additionally integrated are a listing of options, guidance and different files for organic components utilized in medication, and of overseas criteria and reference reagent for organic components.
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Additional resources for Who Expert Committee on Biological Standardization 55th Report
Sample text
5 ml dose was suitable as the minimum potency for yellow fever vaccines assayed in plaque assays. Eight participants submitted data from a total of 102 routine production batches of vaccine. 0 log10 IU/dose. All of these vaccines currently meet the minimum WHO requirement of 1000 LD50 when plaque titres were converted to LD50 equivalents. 0 log10 IU after heating in the accelerated degradation test. The Committee was informed that additional data on vaccine batches stored at the recommended temperature, and on vaccine tested for stability would be collected over the following months.
The flocculation test is still the method of choice of manufacturers to establish the antigenic strength of toxoids although other methods can be used to confirm purity and consistency of production. The Committee agreed at its 2003 meeting to initiate a collaborative study to prepare suitable replacement reagents. The Committee was informed that, in feasibility tests, the candidate replacement reagent for tetanus toxoid preparations was found to be unsuitable for use in the flocculation test because of a high glycine content.
Guidelines allow greater flexibility than recommendations with respect to expected future developments in the field. The document is thus provided for guidance to health administrators. Introduction 44 General considerations 45 Part A. 11 Storage and expiry date 48 48 51 52 52 66 66 67 68 68 68 69 Part B. National control requirements 69 Authors 69 References 71 43 ECB Text 001-138 43 7/11/06, 7:05 PM E Introduction In response to interest from many countries in the development of candidate live attenuated dengue virus vaccines, preliminary draft guidelines on production and quality control specifications for tetravalent dengue vaccine (live) were developed by a small drafting group established by WHO.