Gene synthesis for swine flu vaccine supported by ISO 9001 processes

Scientists working in a laboratory

In April 2009, ISO 9001:2000-certified Geneart AG, the world-wide leading supplier for synthetic genes, produced genes for the development of a vaccine against swine flu in just 3 to 5 days, a remarkable achievement considering the first cases had been reported only 2 weeks prior.

Since 2005 all of Geneart's processes have conformed with ISO 9001:2000 Quality management systems – Requirements. The German-based company is reportedly the first gene synthesis provider to have achieved this distinction.

Gene synthesis is the Geneart's core business. Since its market entry in 2000, capacities have nearly doubled each year from 10 genes per month to currently more than 3000 per month. Early ISO 9001 implementation has been credited as an important factor in Geneart's rapid growth.

While the actual production processes did not need to be re-adjusted during the certification process, additional processes like regular equipment maintenance were implemented. Over time, the initially higher costs of maintenance have been offset by a reduction of non-budgeted equipment failure. The strict certification requirements combined with increased transparency and continual implementation of improvements have also raised automation and miniaturisation levels.

Certification has paid off for Geneart's customers too, with ISO 9001 implementation ensuring more stable processes, greater delivery reliability, and reduced prices from higher efficiencies.

Summarised from an article in ISO Management Systems, November-December 2009, Vol.9, No.6.

Published in health.