Bolstered by a $30-million equity infusion from its current private investors, the company will make significant upgrades to its analytical, formulation, and manufacturing capabilities. AAI-Pharma's recently appointed senior vice-president for operations, Lee Karras, provided an update about the plans during November's AAPS Annual Meeting.
AAIPharma will make a major investment in its Charleston, South Carolina parenteral manufacturing facility, spending $1.3 million on various upgrades. Planned projects will improve people and material flow, provide better engineering controls, and add GMP warehouse space. The improvements, says Karras, will enable the Charleston facility to meet the compliance standards of the Medicines and Healthcare products Regulatory Agency (MHRA, the UK regulatory body) and European Union (EU) compliance standards, so that clinical-trial materials manufactured at the facility can be exported to EU countries. The 48,000-ft2 Charleston facility, which has two filling suites and a 54-ft2 lyophilization unit, already has FDA approval.
Along with upgrading its existing capabilities, AAIPharma will be expanding its CMC development services offerings, according to Karras. The company recently launched a physical-chemistry practice. Physical Chemistry is a hot area in which opportunities are underscored by the recent acquisition activity in that area, including Aptuit's (Greenwich, CT) purchase of SSCI (Fort Wayne, IN) and SAFC's (St. Louis, MO) acquisition of Pharmorphix (Cambridge, UK). Karras said the company is likely to add clinical packaging and distribution in the coming year.
As it reorganizes, AAIPharma is pursuing an integrated services model, packaging together clinical and nonclinical capabilities to target specific market segments. It is currently promoting packaged services under the brand names "AAIGeneric," "AAIBiotech," and "AAIOncology." The latter offering was created following the recent acquistion of Cvitkovic & Associés Consultants, S.A., (CAC) a Paris-based CRO specializing in oncology drug development. CAC has experience in running early-stage clinical trials as well as large, international Phase II/III trials for oncology drugs.