April 15, 2013 (Vol. 33, No. 8)
Your Results Become Our Reputation®
AAIPharma Services is a highly experienced provider of drug development, manufacturing, and analytical services to the pharmaceutical, biotech, and healthcare industries. For over 33 years, AAIPharma has been a leading provider and has grown into a one-stop contract development and manufacturing organization (CDMO) that supports all phases of drug product development. Our expertise in partnering prior to Phase I studies and supporting our clients through each step of the product development cycle makes AAIPharma a unique provider of services—from Compound to Clinic®.
About the Company
Headquartered in Wilmington, NC, AAIPharma has five laboratory and manufacturing locations located throughout North America totaling approximately 370,000 sq. ft. and serving over 600 clients worldwide. AAIPharma’s extensive array of service offerings includes parenteral manufacturing (Charleston, SC); solid oral dosage form manufacturing, formulation development, packaging, and labeling (Wilmington, NC); and analytical development/testing and microbiological testing services (Wilmington, NC, Durham, NC, St. Louis, MO, Edison, NJ).
Markets Served
AAIPharma supports pharmaceutical, biopharmaceutical, animal health, and life science companies around the globe from its FDA- and EU-compliant facilities in the United States. Companies of all sizes including virtual, large, generic, and specialty pharmaceutical benefit from our extensive expertise and breadth of services. Our unique combination of industry acumen, technical expertise, and regulatory knowledge make AAIPharma a leading provider of comprehensive contract drug development, manufacturing, and analytical services.
Capabilities
AAIPharma’s broad array of capabilities are best described as three integrated sets of services: product development, analytical testing, and manufacturing and packaging services. Each of AAIPharma’s services is readily available as a stand-alone offering. Alternatively, a full-scale program can be developed to take full advantage of AAIPharma’s multiple capabilities.
Our Analytical Services teams, located in Edison, NJ, St. Louis, MO, Durham, NC, and Wilmington, NC, are known for their industry-leading turnaround times and exceptional quality. AAIPharma’s analysts support any project at any phase and are experts in method development and validation, QC chemistry, biopharmaceutical testing and characterization, extractable and leachable testing, microbiology, and stability testing. Our experienced biopharmaceutical development services team is equipped with the tools to support characterization of new entities and testing of well-characterized molecules, including: micro-flow imaging, multi-angle laser light-scattering detection, dynamic light-scattering detection, and capillary IEF.
Product development services begin with preformulation studies and progress seamlessly through the preclinical and clinical drug product development cycle. Our formulation development teams are experts in excipient compatibility, prototype development, bioavailability enhancement, and placebo development. In-house analytical development teams provide consistent analytical support of drug candidates at each stage, and dedicated project managers ensure the project teams are aligned every step of the way. Pilot-scale facilities within both the parenteral and solid oral dosage manufacturing facilities enhance AAIPharma’s ability to scale-up production as demand for clinical trial materials or commercial product increases.
The recently expanded 48,000 square foot parenteral manufacturing facility in Charleston, SC, is focused on the production of diverse sterile injectable products: solutions (aseptically processed and terminally sterilized), emulsions, and lyophilized products for injection. With expertise in small molecules, biologics, proteins, oncology compounds, potent compounds, and DEA-controlled substances, the manufacturing team has an exemplary inspection history with both domestic and European agencies. The facility utilizes disposable product contact components and maintains redundant critical capabilities, which minimize potential downtime. The fill and finish capabilities of the facility support vial sizes from 2 mL to 50 mL and batch sizes from a few hundred vials to 20,000, or more. Batches can also include 100% weight check.
Oral solid dosage forms including tablets, capsules, powder in capsule, and powder in bottle are produced in our U.S.- and EU-compliant manufacturing facility located in Wilmington, NC. On-site formulation development, pilot suites, flexible production rooms, and the ability to process batches up to 650 kg provide assurance that we can scale with you as demand increases.
Further complementing AAIPharma’s service offerings are its integrated packaging, labeling, and warehouse and distribution facilities. Recently updated production space, combined with modernized lines, automated in-line rotary checkweighers, and temperature/humidity-controlled storage enable AAIPharma to provide customized packaging, labeling, and kitting options to supply your clinical trials. Unit dose packaging equipment allows us to produce customized thermoform and blister packaging with a variety of materials.
R&D spending by the biopharmaceutical industry is significantly higher than any other industry in the manufacturing sector, and access to the latest technology is yet another reason our clients rely on us. AAIPharma is an experienced and dependable CDMO that continues to invest in advanced equipment and infrastructure to ensure our scientists and operators have the proper tools at their disposal to exceed our clients’ expectations. Your results become our reputation®.
AAIPharma Services Corp
2320 Scientific Park Drive
Wilmington, NC 28405
Phone: 910.254.7000
Website: www.aaipharma.com
Number of Employees: >500
