AAIPharma completes $2m boost to manufacturing capacity
of upgrades to two of its manufacturing plants in the US.
The two sites, in Charleston, South Carolina and Wilmington, North Carolina, were treated to a $2m dollar face-lift to increase capacity and ensure compliance with EU aseptic processing and testing guidelines. The parenteral manufacturing facility in Charleston is already Food and Drug Administration (FDA) compliant, but the firm wanted to ensure that customers targeting the European market were also catered for. "Although the facility is already fully US-FDA compliant, this upgrade positions the Charleston facility to meet the expectations of the MHRA [Medicines and Healthcare products Regulatory Agency] in the UK," said Lee Karras, AAIPharma senior vice president of North Americam pharmaceutical operations. "In addition, this complements our formulation and biotech analytical development businesses where we expect to see continued growth." The upgrades to the site will improve the plant's 'material and people flow' according to the company, as well as enhancing the heating, ventilation and air conditioning (HVAC) capacity to allow greater control of the plant environment. The Charleston facility develops and manufactures sterile product dosage forms for small molecules, biologics and proteins, and as well as producing parenteral products also focuses on providing clinical trial materials for Phase I to III trials. The Wilmington facility, also approved by the FDA and certified compliant with current good manufacturing practice (cGMP), has been treated to two new aseptic barrier isolators (from Swiss clean room equipment manufacturers Skan), equipped with integrated varporized hydrogen peroxide decontamination technology. It's hoped that this upgrade with support sterile product release for material to be supplied in the EU. Currently, the Wilmington site specializes in solid oral dosage forms, toxic and potent compounds and hard to make products. The company anticipates full validation of both sites along with EU approval of the Charleston plant in the second quarter of 2007, with the enhancements promising to "add significant value to the existing client base," according to a company spokesperson. Already having established a presence all over the North America, South America, in Europe and in Asia, with this move AAIPharma claims it has become one of the few service providers with the ability to take parenteral and biotech products all the way from early pharmaceutical development and manufacturing though to full global clinical development.
