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GSK Bio licenses preservative-free filling process

20-Oct-2004

Belgium-based GlaxoSmithKline Biologicals has licensed a new production technology for its vaccines business that should do away with the need to use preservatives in the manufacturing process.

The Intact technology, developed by Medical-Instill (Med-Instill) of the US, can be used to produce sterile vials, pre-filled syringes and cartridges or similar devices used to hold vaccines and pharmaceutical injectables.

This system could yield significant advantages for GSK Bio, both in terms of cost-savings and in the positioning of its products in the marketplace, given concerns among the public of the safety of vaccines. This safety aspect often relates to the inclusion of preservatives in vaccines, although it must be noted that the data does not support this view.

Moreover, the companies note that the technology could have been used to overcome the current flu vaccine shortage in the US, caused by contamination problems at a UK plant run by Chiron, which supplies 50 per cent of the US market requirement.

Using Med-Instill's approach, closed vials are filled through a stopper with a needle and re-sealed with a laser. A pure physical barrier that prevents contamination replaces the chemicals currently added to destroy potential germs. This means higher patient safety levels, and compliance that has been engineered through a relatively simple process, said Daniel Py, Med-Instill's chairman.

The technology licensed under the deal brings a new level of reliability, speed and efficiency to the filling of sterile injectables, he claimed. It allows for easier storage, quicker filling and a faster turnaround from storage to syringe.

GSK-Bio intends to implement the technology in its own manufacturing and also to offer it to the rest of the industry through its dedicated Belgian subsidiary Aseptic Technologies.

"Preservative-free sterilisation during and after the filling process is not performed by any other company on a large scale today. By dramatically simplifying the sterile filling process this new approach provides higher safety levels at lower capital and operating costs," said the firm in a statement.

"This is the beginning of a new standard for sterile injectables -- one that we envision governments and regulatory agencies will quickly embrace," said Dr Py.

Ensuring supply

Dr Py noted that one of the factors contributing to the current flu-vaccine shortage in the US is the inability of companies to guarantee a sterile environment for their injectables. The Intact process solves this problem by allowing manufacturers to have greater confidence in sterility, turnaround new vaccines quickly and respond to shortages without fear of contamination.

The transaction includes the transfer of assets such as filling equipment, development results and rights under patents. Med- Instill retains the rights to the technology in other fields such as for ophthalmic and topical pharmaceuticals and for the cosmetic and beverage industries.

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