AAIPharma Grows and Strengthens Parenteral Manufacturing and Sterile Product Release Capabilities

AAIPharma Grows and Strengthens Parenteral Manufacturing and Sterile Product Release Capabilities
Apr 03, 2007
SmartBrief
WILMINGTON, N.C.-- (BUSINESS WIRE) -- AAIPharma Inc. announced today the completion of over $2.0 million in upgrades to its parenteral manufacturing facility in Charleston, South Carolina and its sterile product release operation in Wilmington, North Carolina. Improvements were made to increase capacity and to ensure compliance with European Union (EU) aseptic processing and testing guidelines, positioning the facilities to be approved for aseptic filling and release of products exported to the EU.
According to Lee Karras, AAIPharma senior vice president of North American pharmaceutical operations, ?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 US-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 upgrade in the Charleston facility significantly improves the plant?s material and people flow as well as enhances the HVAC capacity for greater control of the plant environment. To support sterile product release for material to be supplied in the European Union, the Company has also added two Skan AG ARIS Isolators equipped with integrated vaporized hydrogen peroxide decontamination technology to its microbiology laboratory in Wilmington, North Carolina.
?These facility enhancements are part of AAIPharma?s strategic commitment to process improvement and innovation,? said Ludo Reynders, Ph.D., AAIPharma president and CEO. ?We are continuing to make significant investments in capabilities and technologies aimed toward the evolving needs of our global customer base.?
AAIPharma expects both facilities to be fully validated and granted EU approval for the Charleston facility in the second quarter of 2007. With these improvements in place, AAIPharma 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.
About AAIPharma
AAIPharma Inc. is a global provider of product development and support services to the pharmaceutical, biotechnology and medical device industries. From a single test through a range of integrated service offerings, we create value to an industry in search of productivity and innovation. For more information on the Company, please visit AAIPharma's website at www.aaipharma.com.
AAIPharma Inc.
Luke Heagle, +1 910-254-7066