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®.