AAIPharma strengthens parenteral manufacturing capabilities

AAIPharma has completed upgrades amounting to more than US$2m (Euro 1.5m) to its parenteral manufacturing facility in Charleston, South Carolina and its sterile product release operation in Wilmington, North Carolina.

The improvements were made to increase capacity and to ensure compliance with European Union aseptic processing and testing guidelines, positioning the facilities to be approved for aseptic filling and release of products exported to the EU.

The upgrade in the Charleston facility significantly improves the plant's material and people flow as well as enhancing the HVAC capacity for greater control of the plant environment. 'Although the facility is already fully US-FDA compliant, this upgrade positions the Charleston facility to meet the expectations of the MHRA in the UK,' said Lee Karras, AAIPharma senior vice president of North American pharmaceutical operations.

'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.'

To support sterile product release for material to be supplied in the EU, the company has also added two ARIS Isolators, manufactured by Swiss company Skan, to its microbiology laboratory in Wilmington, North Carolina. These are equipped with integrated vaporised hydrogen peroxide decontamination technology.

AAIPharma expects both facilities to be fully validated and EU approval granted for the Charleston facility in the second quarter of 2007. With these improvements in place, AAIPharma says it has become one of few service providers with the ability to move parenteral and biotech products from early pharmaceutical development and manufacturing into full global clinical development.