For more than 30 years, AAIPharma Services has provided drug product development services to pharmaceutical, biotechnology, and medical device companies around the world. Our team of 400+pharmaceutical scientists and professionals, including 20 PhDs, pride themselves on providing solutions to the most difficult drug development and manufacturing challenges. We have developed drugs in all major therapeutic areas, have had our work included in over 500 INDs, and currently provide services in support of more than 50 NDAs/ANDAs. No matter how large or small your company, we can tailor a development program to fit your specific needs.
The goal of our Analytical and Formulation Development teams is to act as an extension of your team and in partnership, effectively develop your molecules into viable clinical and ultimately, commercial drug products. We have over 30 years of experience in providing analytical and formulation development support for drug product development and manufacturing programs. We offer a full spectrum of services to meet all of your analytical and formulation development outsourcing needs. Our scientists are rooted in science, and grounded in service.
AAIPharma Services provides CGMP manufacturing services for clinical and commercial products at its solid dosage and sterile product manufacturing facilities. The facilities located in Charleston, SC (sterile) and Wilmington, NC (solid dose) are comparable in size/staffing and provide flexible capabilities for the processing of a wide range of pharmaceutical drug products, including controlled substances and potent compounds. Clinical manufacturing activity ranges from Phase I through Phase III trials with scale-up and validation support to address commercial launch requirements and to support subsequent commercial supply. Both sites are FDA and MHRA approved and produce products for the US and European markets.
Clinical Packaging and Distribution
Whether you require clinical or commercial packaging, AAIPharma Services can meet your needs. For clinical trial supplies, AAIPharma Services can provide custom packaging, labeling, and kitting all at one site. Our global capable distribution site allows us to package and distribute supplies into Europe and South America, as well as offer QP services for materials intended for clinical trials conducted in the EU. We can also address any of your special packaging needs such as square bottles, blisters, cartons, vials, ancillary supplies, concomitant medications, cases, and cachets. Semi-automated packaging lines are used for clinical and commercial packaging processes. Manual packaging is available for custom configurations. Our global distribution network adheres to the strict rules and regulations necessary for global transfer. We offer temperature and humidity controlled storage, refrigerated (2–8 °C) with temperature monitoring and validated shipment configurations. Frozen shipments are also available. We can readily meet your global clinical supplies packaging and distribution requirements.
Drug Delivery Technologies
AAIPharma Services Formulation Development group has improved the pharmacokinetics of drugs by developing technologies, processes, expertise, and intellectual property intended to improve a products efficacy, safety, and patient compliance. AAIPharma Services development program has earned a reputation for solving complex drug delivery challenges for our clients and partners. With a number of drug delivery platforms, AAIPharma Services can be a key resource for new tools and strategies to expand the usefulness of your medicines in effective patient care. Our portfolio of drug delivery technologies provides vehicles to deliver the active pharmaceutical ingredient in ways that are more effective and efficient, or provide other properties that better meet the therapeutic needs of the patient base. These value-added enhancements improve the therapeutic performance and market position of your drug products.
Barry D. Johnson is a senior marketing manager at AAI Pharma Services Corp., 2140 Hamrick Dr., Raleigh, NC 27615; 910-254-7000; firstname.lastname@example.org.