bioengineered products

Pre-filled syringes now generate the fastest growth opportunities among all pharmaceutical packaging products.

When based on performance advantages in drug delivery and the introduction of new bioengineered medicines, pre-filled syringes are experiencing an annual growth rate of ten per cent and this is no more evident than at the Unilife Corporation, a US-based medical device company.

The firm, which specialises in the design, development, manufacture and supply of a proprietary range of retractable syringes, has announced that it has secured US government financial backing to support the construction of its new global headquarters and manufacturing facility in York, Pennsylvania.

Construction of the company's state-of-the-art safety syringe manufacturing plant remains on schedule for completion in late 2010, with the facility designed by leading pharmaceutical architects to have an annual capacity to manufacture up to 400 million units of Unilife's proprietary range of safety syringes.

The combined financial commitments by US and Pennsylvania government agencies represent approximately half of the total $31 million (£19.4 million) projected cost of the York facility and Alan Shortall, chief executive of Unilife, expressed his thanks to the government for its continued collaboration with the company.

He explained: "I believe this strong government backing reflects our status as a fast-growing Pennsylvania company that is committed to local high-skilled job creation and the production of best-in-class syringes which can provide a safer environment for healthcare workers and enhanced care for patients."

Tom Williams, state director of the US Department of Agriculture, said it is working to ensure that rural communities have the tools they need to expand economic opportunity and said that Unilife's "strong life science investment" in the area will create highly-skilled jobs in a high-tech, fast-growing market sector.

In order to ensure that facility construction timelines remain in line with the accelerated industrialisation programme for the Unifill's ready-to-fill, or pre-filled, syringe, the company has already invested approximately $10 million of its own cash reserves in the project.

According to the company, the York facility will feature "world-class manufacturing, environmental control and material handling systems" which will help to maximise overall production efficiencies and meet the high pharmaceutical standards needed for primary drug containers.

In addition, it will incorporate eight Class 8 (100,000) and three Class 7 (10,000) clean rooms where environmental factors such as temperature, humidity and particulate matter will be tightly controlled. [inlinead] An advanced water-for-injection system will also meet the established pharmaceutical standards of water purity required for the production of the Unifill ready-to-fill syringe, the company claims.

Further amenities include a product development centre, a microbiology lab, quality inspection and control rooms and a fully segregated warehouse for efficient inventory management.

Mr. Shortall said he is "excited" by the progress made at the plant's site and the fact that development is on time, despite construction starting in December 2009, which was the beginning of one of the worst winters on record in Pennsylvania's history.

"We are confident that the facility will be ready for operations by the end of this year to align with the industrialisation programme for the Unifill syringe," he explained.

As is now standard in the sector, the company will be looking at how to best implement filling lines and considering how packaging and drug development processes can ensure the safety and efficacy of the end product.

At the York facility, the installation of clean rooms, air-conditioning and other essential systems in the production wing is well underway, which has cleared the path for the installation of initial automated assembly lines and other production equipment later this year.

In addition, work on the construction of the framework of the 54,000 sq ft office wing, which will serve as Unilife's global headquarters and support management functions, has recently been completed.

Mr. Shortall commented: "This state-of-the-art facility, together with the rapid expansion of our operational capabilities and internal expertise, will help us meet anticipated demand for our products and become a preferred, long-term supplier to a number of pharmaceutical companies."

He added that Unilife has secured zoning approval for a potential 100,000 sq ft extension at the York facility that would increase the total annual production capacity of the site to as many as one billion units of the company's proprietary range of safety syringes.

With the pre-filled syringe market set for continued growth in the coming years, it is no surprise that companies such as Unilife are taking steps to ensure they are ready for the boom and it is likely only a matter of time before others follow suit.

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