AAIPharma Upgrades Parenteral and Sterile Capabilities

AAIPharma, Inc. completed more than $2 million in upgrades to its parenteral manufacturing facility in Charleston, SC and its sterile product release operation in Wilmington, NC. The improvements were made to increase capacity and to help ensure compliance with EU aseptic processing and testing guidelines for products exported to the EU.

Lee Karras, AAIPharma’s senior vice president of North American pharmaceutical operations, remarked, “By making this investment, we have made a commitment to existing and future customers that parenteral manufacturing is important to AAIPharma. Although the facility is already fully FDA compliant, this upgrade positions the Charleston facility to meet the expectations of the MHRA in the UK. This is of particular importance to customers who wish to conduct clinical trials in the EU as well as export marketed product to the EU. In addition, this complements our formulation and biotech analytical development businesses where we expect to see continued growth.”

The Charleston facility upgrades included improvements in plant material and people flow as well as HVAC capacity for greater control of the plant environment. To support sterile product release for material to be supplied in the EU, the company has added two Skan AG ARIS Isolators equipped with integrated vaporized hydrogen peroxide decontamination technology to its microbiology laboratory in Wilmington, NC.

“These facility enhancements are part of AAIPharma’s strategic commitment to process improvement and innovation,” said Ludo Reynders, Ph.D., AAIPharma president and chief executive officer. “We are continuing to make significant investments in capabilities and technologies aimed toward the evolving needs of our global customer base.” The company expects both facilities to be fully validated and granted EU approval for the Charleston facility in the second quarter of 2007.