Abstract

Subhash Ayra and Nirmala Agarwal (Oct 4, p 1159)1Ayra SC Agarwal N Power shutdowns and biological standards.Lancet. 2003; 362: 1159Summary Full Text Full Text PDF Scopus (1) Google Scholar question whether biological standards were inadvertent casualties of recent power shutdowns in North America. They postulate that low-temperature storage of biological reference preparations could have been interrupted for several days. They are concerned that such an event would result in a loss of biological activity in the reference material sufficient to cause a discontinuity of the international unit, which is used to express the potency of many biological medicines.WHO, through its biological standardisation programme, has established and maintains more than 300 biological reference preparations for global use.2World Health OrganisationBiological substances: international standards and reference reagents.WHO Tech Rep Ser. 2002; 904 (accessed Nov 13, 2003).: 101-103http://www.who.int/biologicalsGoogle Scholar The custodian laboratories for these standards are at the National Institute for Biological Standards and Control, UK; the Sanquin Blood Supply Foundation, Netherlands; the National Institute for Allergies and Infectious Diseases, Washington, DC, USA; and the University of Washington, WA, USA. None of the repository laboratories were affected by the power outages. Furthermore, if a power outage had occurred, each of the laboratories have comprehensive contingency plans including monitoring, alarm systems, and response procedures. Systems are also in place to avoid accidental or intentional tampering with freezer or alarm settings. The laboratories have back-up emergency generators, and personnel are trained in maintenance of materials at low temperature.Custody of international biological reference materials clearly requires substantial commitment and investment on behalf of the host institution. The scientific community should take note of the need to support this largely unheralded but essential activity. Subhash Ayra and Nirmala Agarwal (Oct 4, p 1159)1Ayra SC Agarwal N Power shutdowns and biological standards.Lancet. 2003; 362: 1159Summary Full Text Full Text PDF Scopus (1) Google Scholar question whether biological standards were inadvertent casualties of recent power shutdowns in North America. They postulate that low-temperature storage of biological reference preparations could have been interrupted for several days. They are concerned that such an event would result in a loss of biological activity in the reference material sufficient to cause a discontinuity of the international unit, which is used to express the potency of many biological medicines. WHO, through its biological standardisation programme, has established and maintains more than 300 biological reference preparations for global use.2World Health OrganisationBiological substances: international standards and reference reagents.WHO Tech Rep Ser. 2002; 904 (accessed Nov 13, 2003).: 101-103http://www.who.int/biologicalsGoogle Scholar The custodian laboratories for these standards are at the National Institute for Biological Standards and Control, UK; the Sanquin Blood Supply Foundation, Netherlands; the National Institute for Allergies and Infectious Diseases, Washington, DC, USA; and the University of Washington, WA, USA. None of the repository laboratories were affected by the power outages. Furthermore, if a power outage had occurred, each of the laboratories have comprehensive contingency plans including monitoring, alarm systems, and response procedures. Systems are also in place to avoid accidental or intentional tampering with freezer or alarm settings. The laboratories have back-up emergency generators, and personnel are trained in maintenance of materials at low temperature. Custody of international biological reference materials clearly requires substantial commitment and investment on behalf of the host institution. The scientific community should take note of the need to support this largely unheralded but essential activity.

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