Novo Nordisk’s insulin manufacturing facility in North Carolina is located south-east of Raleigh near the town of Clayton, nearly 35 miles west of Research Triangle. The facility undertakes formulation, aseptic filling, packaging and distribution of insulin products. It is the only insulin manufacturing facility of the company in the US and the second in North Carolina. The FDA approved facility operates 24/7 with 420 full-time employees.
Opened in 1996, the facility has been expanded over the years to add new capabilities. A $12m expansion in 2004 and a $100m two-phase expansion in 2007 increased the facility’s size by 19,000ft² and 181,000ft² besides doubling its insulin filling capabilities. In 2007, the facility began the first domestic production of FlexPen.
A $73m expansion of the facility was announced in October 2010. The expansion will add two new final assembly lines and two new packing lines, and refurbish the building. Scheduled for completion in 2012, the expansion will increase the production capacity for insulin delivery devices (delivered as autodosers) and provide better treatment options for diabetes in the US. It will create 85 new jobs at the facility.
Novo Nordisk is partnering with plastic manufacturer Nypro for the supply of parts for the new insulin delivery device that is awaiting FDA approval. In order to meet the demand, Nypro is also expanding its facility in Buncombe County outside of Asheville by 75,000ft². Novo Nordisk and Nypro are together investing $161m towards the expansion, including $88m for Nypro’s plant.
The Clayton site spans 264 acres, and includes offices and laboratory space for raw material quality assurance, in-process testing and finished products in addition to the manufacturing facility.
The manufacturing facility at the Clayton site occupies 328,500ft². The latest expansion will add approximately 21,000ft² to the facility.
The Clayton facility develops six different products for the treatment of diabetes, including Levemir Flexpen, a new disposable, prefilled insulin pen used to dispense insulin detemir from rDNA origin. The facility also undertakes packaging and distribution of diabetic treatment products.
As diabetic patients in the US are shifting from the conventional vial and syringe method to a pen dosage device for administering insulin, the demand for FlexPen has been growing rapidly.
Aseptic manufacturing and bioprocessing are the two core technologies used at the facility. The facility uses recombinant DNA technology to produce insulin. The insulin production process begins with product formulation wherein human insulin crystals are mixed with chemical stabilisers and highly purified water.
The resultant product is filled into glass vials and cartridges under aseptic conditions. Following inspection, the products are packaged for distribution.
The expansion will be funded through incentives. Novo Nordisk has received state incentives amounting to $2.3m for the expansion. The expansion project has also been approved to receive incentive support amounting to $400,000 from the state’s One North Carolina Fund and an incentive package from Job Development Investment Grant (JDIG).
Novo Nordisk will be entitled to receive a rebate of 65% of the state withholding taxes on new hires. The company will get up to $840,000 from JDIG if it meets its target for new jobs and retains them for 10 years.
The company will also get $300,000 for infrastructure improvement from the state Department of Transportation grant. The facility will receive an additional incentive package of $3.3m from Johnston County upon approval by the county commissioners.
The Clayton site was chosen for expansion due to the amount of financial support through local and state resources. In addition, Nypro has been awarded a grant worth $200,000 for its contribution towards the expansion.
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