Institute for Biological Standards and Control

Guidelines for the Blood Transfusion Services in the United Kingdom, National Institute For Biological Standards and Control, Potters Bar, 1992. 

Preliminary report on "Collaborative Study on the Proposed International Standard for Somatropin," National Institute for Biological Standards and Control, London, Dec. 21, 1992. 

In Tables 6.3 and 6.4 RMs of three major producers are mentioned, i.e. the World Health Organization (WHO, International Standards), BCR (European Union, CRMs) and the National Institute of Standards and Technology (NIST, USA, SRMs). Some important national producers of clinical reference materials are the Chemicals and Inspection Testing Institute (CITI, Japan), National Institute for Biological Standards and Control (NIBSC, UK), and Deutsche Gesellschaft fiir Klinische Chemie (DGKC). There are numerous commercial producers of secondary reference materials. 

Institut de Recherches de la Siderurgie, France International Organization for Standardization ISO Council Committee on Reference Materials International Union for Pure and Applied Chemistry Laboratory of the Government Chemist, UK, formerly NPL National Bureau of Standards, USA, now NIST National Committee for Clinical Laboratory Standards, USA National Institute for Biological Standards and Control, UK Japanese National Institute for Environmental Studies National Institute of Occup. Health, Oslo, Norway National Institute of Standards and Technology, USA, formerly NBS,... 

Quality control of acellular pertussis vaccines presents particular problems related to the various methods used for preparation of the active components, the different compositions of the final formulations, and different amounts of antigen. Researchers in the National Institute for Biological Standards and Control in the UK have presented a strategy capable of addressing the key problem areas likely to be encountered with all existing types of acellular pertussis vaccines and combinations (2). Their proposal could be considered as a starting point for improvement of quality control programs for these vaccines. 

National Institute for Biological Standards and Control Blanche Lane South Mimms Potters Bar... 

The Biological Standards Act (1975) established the National Biological Standards Board. This Board, appointed by the UK health ministers and funded by the Health Department, is responsible for standards and control of biological substances, that is substances whose purity and potency cannot be adequately tested by chemical means, such as hormones, blood products and vaccines. The Board operates through the executive arm, the National Institute for Biological Standards and Control. 

The National Institute for Biological Standards and Control (NIBSC) is a UK public body reporting to the UK Department of Health. Its mission is to safeguard and enhance public health through the standardization and control of biological medicines. The provision of these standards is a central feature of the work of NIBSC [1,2]. 

The final, purified bulk product is thoroughly characterized and compared to reference standards established by the manufacturer for new molecular entities or available from the United States Pharmacopoeia (USP) or the World Health Organization s National Institute of Biological Standards and Control. Characterization tests of proteins may include biologic potency assays, chromatographic assays, gel... 

Various insulin preparations, including human insulin, are used as insulin calibrators. For ease of comparison of results among laboratories, the insulin calibrator is expressed in terms of international units (lU). One international unit of insulin is equal to approximately 43p,g of the World Health Organization (WHO) first International Reference Preparation (1st IRP) Code 66/304 (National Institute of Biological Standards and Control, South Mimms, Potters Bar, Hertfordshire, United Kingdom), which is 100% human insulin. 

Principle. Accurate measurement of proinsuJin has been difficult for several reasons the blood concentrations are low antibody production is difficult most antisera cross-react with insulin and C-peptide, which are present in much higher concentrations the assays measure intermediate cleavage forms of proinsuhn and reference preparations of pure proinsulin were not readily available. Therefore few accurate data are availabie in the hterature on plasma proinsulin. These problems have, to a large extent, been overcome by the availability of biosynthetic proinsulin, which has allowed the production of monoclonal antibodies to proin-sulin and provided reliable proinsulin calibrators and reference preparations. An International Reference Preparation for human proinsulin (code 84/611) is available from the National Institute of Biological Standards and Controls (Potters Bar, United Kingdom). Earlier assays may have overestimated proinsulin concentrations. ... 

Indebtedness is expressed to Prof. R. A. Fisher and Dr. Frank A. Yates for permission to reprint Tables III-VI from their book Statistical Tables for Biological, Agricultural, and Medical Research (Oliver Boyd, Edinburgh and London), and to the British Standards Institution for permission to reprint certain factors for Quality Control Charts from B.S, 600R, Quality Control Charts. ... 

Standard paeonflorin was purchased from Natural Institute for the Control of Pharmaceutical and Biological Products. Qinggan Injection was made up by Affiliated Third Hospital, Sun Yat-sen University of Medical Sciences. All the solvents used were of analytical grade. 

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