AST, a leading provider of flexible drug product manufacturing solutions, has announced the placement of its advanced isolated GENiSYS C fill-finish system with Bora Pharmaceuticals, a premier international contract development and manufacturing organization (CDMO). The flexible, multi-format system will be placed in their 87,000-square-foot clinical-to-commercial drug product manufacturing facility in Baltimore, Maryland.
“Bora is more frequently seeing demand for drug product fill and finish of potent drug candidates and approved treatments, as well as for rare and orphan diseases,” said J.D. Mowery, President of Bora’s CDMO Division. “The addition of a precision isolator line adds to our overall capacity and increases our flexibility and scalability. I look forward to adding to our capabilities in the U.S. so that we remain ready to meet rising demand from clients, both domestic and international.”
Bora’s addition of AST’s GENiSYS C line will leverage next-generation turnkey technology integrated with AST's Atmos™ isolator that provides groundbreaking rapid low-concentration hydrogen peroxide technology from CURIS System. Featuring intuitive, recipe-driven changeover, the GENiSYS C minimizes operational downtime and streamlines processing for RTU vials, syringes, and cartridges on a single line. The fully integrated fill-finish solution is American-built with end-to-end supply, service, and project support from AST.
“AST’s isolated GENiSYS C is a flexible, high-performance solution designed for targeted, multi-modal production,” AST President and CEO Joe Hoff commented. “Bora’s extensive portfolio of services and solutions have enabled critical therapeutics to be delivered to patients in need worldwide. We’re thrilled to be partnering with Bora as they continue to add to their world-class fill-finish manufacturing services.”