In a secretive UK lab, Vivienne Parry meets the scientists who protect the world's health
In a secretive UK lab, Vivienne Parry meets the scientists who protect the world's health
April 21, 2005
Vivienne Parry
The Guardian
Tucked away behind a service station in South Mimms, Hertfordshire, is one of Britain's best-kept secrets. Although we 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 World Service as one of Britain's greatest exports. And this self-effacing organisation is also our frontline defence against pandemic flu.
NIBSC is the leading WHO international standards laboratory and as such is both creator and guardian of standards for 95% of the world's biological medicines and reference materials; a dizzying range, it 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 runs to more than 600 items. Oh, and it is home to the recently opened stem cell bank, too.
Reference back 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.
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 softly spoken Aberdonian virologist who is the institute's director, explains the difficulties of standardising a biological sample. "It's no good weighing two samples of smallpox vaccines to see if they are the same. 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 will have been standardised by this extraordinary facility in Hertfordshire. A Tardis of a building, from the outside it looks like a 70s comprehensive 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.
"If there was some catastrophe and a plane fell on the building, it would take years before we could replace them," says Inglis.
At the heart of the building lies the ampoule bottling plant. Here, 6,000 glass vials an hour whizz through on a journey in which they are first laser etched with details of their contents, then quarter filled by one of three squirting needles and weighed by robots to ensure there are no short measures. Each 8cm-high vial is then filled with nitrogen and dispatched for freeze-drying, before being returned to the bottling plant for flame sealing. The ampoules - over 2m of them - are kept in cavernous freezers. They may remain there for decades. They are dispatched on request, all over the world, using agreed international safety protocols.
Their value is certainly a great deal more than the modest handling charge which is levied for their use. The institute gets core funding from the Department of Health and its standards work is essentially Britain's gift to the world, ensuring the safety of biological products and making a major contribution to public health worldwide. It is not quite as altruistic as it seems, because one consequence is that Britain's scientists are included when important global health decisions are made. Standards, it seems, win brownie points - and international prestige and influence, too. NIBSC allows Britain to punch far above its weight on the global health stage.
Customers are diverse, although all are part of a web dedicated to public health. More than 70 pharmaceutical companies, the UK Blood Transfusion Service, the Health Protection Agency and the Department of Health rely on NIBSC's standards for development. As the Official Medicines Control Laboratory in the UK, it is part of the regulatory process, checking quality for the MHRA and the European Medicines Evaluation Agency both before a product goes on the market, and spot-testing products thereafter. NIBSC scientists also offer an extraordinary biological advice service to the world, free of charge.
Rather more dramatic is its involvement in dangerous pathogens. On site is a Level 4 containment facility. This, the highest grade of safety lab, is one of only a handful in Britain. It is where tigers are turned into pussycats. For instance, the H5N1 avian flu viruses circulating in Asia are way too hazardous for use in vaccine production. They would also kill the hen's eggs that are normally used to grow flu vaccines. "We need to produce something that looks the same to our immune system but which doesn't carry the dangers," says Inglis. NIBSC scientists were the first in the world to use a technique called reverse genetics to develop a seed strain with the characteristics but not the virulence of this virus. They followed it with safety testing. The seed strain was then released to vaccine manufacturers who are using it to produce vaccine stocks for clinical trials.
Fears of pandemic flu are high, but this strain might not turn out to be the one that sweeps across the world. NIBSC is ready, as it was in 2003, when it made a candidate vaccine (a prototype) for the outbreak that appeared in Hong Kong. The instant there is a new outbreak, NIBSC will be called upon by WHO to respond. If pandemic flu does threaten us, the whole world may depend on the ability of NIBSC's South Mimms tiger-tamers for a vaccine.
NIBSC is your worst maiden aunt. It never throws anything away. In one sense, this means an ever-accumulating pile of ampoules. But the value of this archive has been proved time and time again. For instance, when polio vaccines grown in monkey cells and first used in the sixties were claimed to be the source of HIV because of contamination with an HIV-like monkey virus, the institute was able to prove definitively that this was not the case, because it still had ampoules of the original vaccines in its freezers.
Another recent success involved a hospital trust whose freezers were on the blink. The trust wanted to know whether its stock of stored biological products was still effective, despite a brief rise in temperature. The institute tested the stores and was able to reassure the trust that they were still good to go - saving ?1m in the process.
NIBSC is a unique national treasure. It sits at the interface between public health, regulators, industry and academia. When it is incorporated into the 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-recognised world leader. The secret is out.
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