AAIPharma upgrades facilities for EU market

By Kirsty Barnes

- Last updated on GMT

Related tags: European union

AAIPharma has shelled out $2m (€1.5m) on upgrades to two of its
contract manufacturing facilities in order to start making clinical
supplies for the European market.

"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,"​ said the US firm. AAIPharma said the upgrades were made to its parenteral manufacturing facility in Charleston, South Carolina and its sterile product release operation in Wilmington, North Carolina and both are expected to be fully validated, with EU approval also granted for the Charleston facility, by this year's second quarter. In particular, the upgrade in the Charleston facility is said by the firm to "significantly improve the plant's material and people flow as well as enhance the heating, ventilation and air conditioning (HVAC) capacity for greater control of the plant environment."​ The company also said it has added two Skan AG ARIS isolators equipped with integrated vaporised hydrogen peroxide decontamination technology to its microbiology laboratory in Wilmington to "support sterile product release for material to be supplied in the EU." "With these improvements in place, we have 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,"​ the company said. This has also been helped by the December alliance with Mallinckrodt Pharmaceuticals Outsourcing which enabled AAIPharma to provide its customers with the large-scale manufacturing capability that it had been lacking - offering them a "one-stop drug development solution".​ In addition, the firm said that the plant improvements "complement our formulation and biotech analytical development businesses where we expect to see continued growth."​ After narrowly escaping liquidation, the contract manufacturer undertook a reshuffle under Chapter 11 bankruptcy protection last year and sold off its pharmaceutical products division to concentrate purely on assisting with product development and manufacturing for the clinical research phases.

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