Sun, Apr 24, 2005 - Page 19 News List

English lab sets standards in healthcare

By Vivienne Parry  /  THE GUARDIAN

Tucked away behind a motorway service station in South Mimms, southern England, is one of Britain's best-kept secrets. Although one may never have heard of the National Institute of Biological Standards and Control (NIBSC) or of its unique work, in the rest of the world it ranks with the BBC World Service as one of Britain's greatest exports. This self-effacing organization is also our frontline defense against pandemic flu and is home to the recently opened stem-cell bank.

A unique national treasure for the UK, NIBSC sits at the interface between public health, regulators, industry and academia. And when it's incorporated into the country's Health Protection Agency next year (having previously been at arm's length from the Department of Health) it will further strengthen Britain's healthcare science base, which is a little-recognized world leader.

NIBSC is also the leading WHO international standards laboratory and as such is both creator and guardian of standards for 95 percent of the world's biological medicines and reference materials. The dizzying range includes clotting agents such as thrombin or Factor VIII for haemophiliacs, more than 100 hormones, reference allergens such as bee venom, ragweed and birch pollen, biotherapeutics such as interferon and TNF alpha used for rheumatoid arthritis, reagents used in work on HIV/Aids, resources for work on CJD and also bacterial and viral vaccines, many of which are live. The NIBSC catalogue includes more than 600 items.

Reference to an agreed standard is essential for any kind of measurement. For instance, for more than a century the mass of a kilogram has been fixed by that of a cylinder of metal sealed inside three locked safes at the International Bureau of Weights and Measures near Paris. It is used to calibrate the unit's mass precisely.

But biological standards are different. No matter how many times a reference kilogram is accessed, it is undiminished. Not so for biological standards, which get used up as part of the testing process. This means the institute has to prepare tens of thousands of ampoules of each standard, which can then be made available to those who require them in the development or testing of biological products.

Stephen Inglis, the softspoken Scottish virologist who is the institute's director, explained the difficulties of standardizing a biological sample.

"It's no good weighing two samples of smallpox vaccines to see if they are the same," he said. "Although they might have an identical weight, they could be radically different in their biological effect. We need to look at a wide range of different factors in determining how safe and effective these products are going to be."

So if you see IU, short for International Unit, on a medical product, and it is biological in nature, it was standardized by this extraordinary facility. From the outside it looks like a 1970s state school, but inside lies a maze of identical white corridors and laboratories occupied by more than 300 staff, many of whom are world-class scientists.

Security is intense. This is not just because NIBSC is home to some ferocious pathogens, but because the standards themselves are so precious. Without them, many of the world's medicines and vaccines could not be used with confidence, if at all. Every standard is different and each will have required a process of testing and validation lasting at least three years before it is agreed to.

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