AAIPharma Services Corp. is expanding capacity and capabilities at its parenteral manufacturing facility in Charleston, SC. Facility expansions currently underway include the installation of compounding and aseptic processing suites to contain a newly acquired Monoblock vial filling machine, expansion of the microbiology lab, and addition of on-site formulation development capabilities and enhanced analytical instrumentation.
The fill and finish capabilities at the FDA- and EU-approved facility support vial sizes from 2 mL to 50 mL and can include 100% weight check. Manufactured products include solutions, lyophilized products, emulsions and suspensions with batch sizes ranging from a few hundred vials to 20,000 or more.
"In addition to the new fill line, integration of our formulation development and technical services capabilities through the build-out of a new pilot suite allows us to seamlessly support the manufacturing process from development through scale-up, further enhancing our compound to clinic strategy" said Paul Maffuid, Ph.D., vice president of pharmaceutical operations. "Expansion of the existing laboratories with a new cleanroom for on-site sterility testing using isolator technology continues our primary objective of providing a world-class parenteral manufacturing facility with all supporting infrastructure under one roof."