Unilife Corporation inaugurated a commercial manufacturing facility in December 2010. The facility, located in York, Pennsylvania, was completed on schedule, following two phases of construction. The construction had begun in December 2009.
The $31m facility serves as the company’s new corporate headquarters. All operations from Unilife’s old headquarters in Lewisberry were relocated to the new facility by the end of 2010. Production started in March 2011.
Measuring 165,000ft² in area, the York facility sits on a 38-acre site that was acquired by Unilife Cross Farm, a wholly-owned subsidiary of Unilife, for $1.9m.
The facility has been designed with state-of-the-art manufacturing, environmental control and material handling systems. It accommodates over 20,000ft² of clean rooms including eight class 8 (100,000) suites and three class 7 (10,000) clean suites. The suites employ tight controls for environmental factors including temperature, humidity and particulate matter.
The facility also houses a product development centre, microbiology lab, quality inspection and control rooms, and a 20,000ft² fully segmented environment-controlled warehouse for inventory management. A 54,000ft² office area is available to function as the headquarters. It is equipped to handle all the administrative, marketing, new product development, quality laboratories and other operational functions.
Equipment installed within the facility includes automated assembly lines. The automated assembly line for Unitract 1ml insulin syringes is custom designed by Mikron.
There is an advanced water-for-injection (WFI) system that will ensure that water required for the production of the Unifill ready-to-fill syringe meets the established pharmaceutical standards for purity.
The began producing Unilife’s patented ready-to-fill syringes, including the Unitract safety syringes meant for general purposes, in March 2011.
By the second quarter of 2011, final validation of products will be completed and initial orders placed by the existing pharmaceutical partner will be fulfilled. Having started the initial production, Unilife plans to begin discussions with other pharmaceutical companies to secure orders.
The Unitract 1ml syringes are designed for use with injectable drug vials or ampoules. Various variants of the syringe including the tuberculin syringe, insulin syringe and the Unitract safe syringe, which targets the harm reduction markets, will also be produced at the facility.
Annual capacity of the plant in stage 1 is up to 400 million syringes.
Funding for the project came through a mix of sources. Approximately half of the total project cost was secured through loans backed by US and Pennsylvania Government agencies.
Unilife obtained an $18m mortgage loan from the Metro Bank of Harrisburg. In October 2010, the US Department of Agriculture (USDA) stood as guarantor for $10m of this loan amount. An additional $5.4m was received in grants and loans from the Commonwealth of Pennsylvania.
Unilife invested approximately $10m from its own cash reserves to ensure that the construction was completed on schedule to meet the accelerated industrialisation program for the Unifill ready-to-fill syringe.
The design contract for the facility was awarded to Philadelphia-based architectural and engineering design firm L2 Architecture. The contract was valued at $1.56m.
Keystone Redevelopment Group, a Pennsylvania-based real estate company, was appointed as the development manager under a $0.75m contract.
The construction contract was awarded to HSC Builders and Construction Managers (HSC), also based in Pennsylvania. HSC was paid 1.25% of the total cost of work plus two performance bonuses, which amounted to 15% of the fees. The first bonus was paid for completing the utility rooms and installing the equipment by 15 April 2010. The second bonus was received after the completion of phase two construction in December 2010.
In order to meet the growing demand for Unilife’s patented range of syringes from companies in the pharmaceutical and healthcare industries, Unilife plans to initiate further expansions at the facility.
The company has already secured permission for a 100,000ft² expansion that will increase the capacity of the facility to one billion syringes a year. The expansion is aimed at meeting the growing demand for the company’s products.
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