Out of bankruptcy and focused on its contract research business again, AAIPharma (Wilmington, NC) is investing in its traditional core strength: chemistry, manufacturing, and control (CMC) development services.
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.
AAIPharma also is making investments in its formulation and analytical-services capabilities, service areas where it was once
an industry leader. Karras says that the company has managed to retain the scientific talent in those areas from the prebankruptcy
days. Nonetheless, AAIPharma suffered from under-investment during the years when it tried to remake itself as a specialty-pharmaceuticals
company. The company is planning to invest at least $500,000 to update instrumentation, including ultra HPLC and GC–MS capabilities.
Formulation and analytical-chemistry services are provided from the company's Wilmington, North Carolina facility, which also
manufactures solid-dose clinical trial material (CTM). The company also has a small laboratory-services group in New Ulm,
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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.