AAIPharma Grows and Strengthens Parenteral Manufacturing and Sterile Product Release Capabilities
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.