Contract services provider installs new compounding and aseptic processing suites
AAIPharma Services, a US provider of pharmaceutical product development services headquartered in Wilmington, NC is expanding its parenteral manufacturing facility in Charleston, SC.
The company is currently installing compounding and aseptic processing suites to contain a newly acquired Monoblock vial filling machine, expanding the microbiology laboratory and adding on-site formulation development capabilities and enhanced analytical instrumentation.
‘One of AAIPharma's key offerings is the ability to provide our clients with low line loss techniques,’ said Rob Goshert, vice president of sales and client services. ‘We are often challenged by our clients to minimise consumption of their expensive active ingredients, and one way AAIPharma has answered this challenge is through the use of specialised filling processes designed to minimise product loss.’
The new pilot suite allows us seamlessly to support the manufacturing process from development to scale-up
AAIPharma’s FDA- and EU-approved facility uses disposable product contact components and maintains redundant critical capabilities to minimise downtime. The fill and finish capabilities support vial sizes from 2mL to 50mL and can include 100% weight check. Manufactured products include solutions, lyophilised 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 seamlessly to support the manufacturing process from development through scale-up, further enhancing our compound to clinic strategy,’ said Paul Maffuid, 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.’