Agreement enhances drug development efforts for biotech products.
Applied Analytical Industries (API; Wilmington, NC) has entered into a formal alliance with Pharmaceutical Development Center (PDC; Charleston, SC) to provide sterile drug manufacturing services in support of AAI's expanding drug research, development, formulation, and manufacturing activities.
According to Fred Sancilio, chairman and CEO of AAI, the relationship will help AAI scale up its products for eventual market introduction. "This alliance continues to position AAI as a specialty pharmaceutical company focused on solving challenging scientific problems and enabling the company to capture more of the upside opportunity in drug development through royalty sharing, production charges or direct marketing of products in targeted niche therapeutic areas," Sancilio said. "We are pleased to conclude this alliance in what already looks to be a strong second quarter performance, substantially better than last year's results."
Said Terry W. Osborn, president and CEO of PDC, "We share a common goal to develop drugs, rather than just providing pharmaceutical testing. Both PDC and AAI believe that our sterile manufacturing facilities are an essential part of the future of new drug development."
About the Companies
Founded in 1979, privately held PDC provides an array of scientific products and services. Through this deal PDC will supply AAI with sterile processing capability, including producing solutions for injection, lyophilization, and sterile powders. Non-sterile processing capabilities being provided include the manufacturing of solid dosage forms, liquids, and semi-solids.
PDC's core sterile processing competencies include aseptic filling, terminal sterilization, and lyophilization. The company has extensive experience with small molecules as well as proteins, peptides, and polynucleic acids. PDC also offers development and manufacturing services for tablets, capsules, liquids, powders, topicals, semi-solids, and DEA-controlled substances.
AAI is a specialty pharmaceutical and product developer with facilities throughout the United States, Europe, and Asia. Since 1979, AAI has partnered with pharmaceutical companies on both a fee-for-service and royalty and milestone payment basis. AAI has earned a reputation for solving complex pharmaceutical challenges through analytical testing and formulations development techniques, as well as validation and regulatory affairs support services.
AAI maintains European headquarters in Neu-Ulm, Germany and additional U.S. offices in Brunswick, NJ; Boston, MA; Research Triangle Park, NC; and Kansas City, KS. AAI's European and Asian facilities are located in Munich, Germany; Paris, France; and Wuhan, China.
For more information: Pharmaceutical Development Center, 4221 Faber Place Dr., Charleston, SC 29405. Tel: 843-746-2500. Fax: 843-746-2550. Applied Analytical Industries Inc., 2320 Scientific Park Dr., Wilmington, NC 28405. Tel: 910-254-7000. Fax 910-815-2300.
Edited by Angelo DePalma