Oct. 22, 2019, Greenville, N.C. – Metrics Contract Services (Metrics) — a full-service global contract development and manufacturing organization (CDMO) specializing in oral dosage forms — has completed the installation of a new high-shear mixer from ACG Engineering at its facility in Greenville, North Carolina.
A division of Mayne Pharma Inc., Metrics uses the QUEST HSM III granulator to transition formulations from initial development to the process-validation stage and, ultimately, to commercial production.
The QUEST HSM III was developed jointly with Xertecs, ACG’s European Innovation and Design Centre. The QUEST HSM III incorporates 12-bar pressure shock resistance and ACG’s signature X-ONE COMMAND™ process control system. Designed to facilitate compliance with cGMP standards, the versatile QUEST HSM III features interchangeable process bowls of 15, 30 and 65 liters providing a wide range of batch sizes and torque measurement instrumentation for process end point determination.
The new granulator further expands Metrics’ portfolio of pharmaceutical manufacturing and service capabilities, which include formulation development, pre-clinical and Phases I-III clinical trial materials manufacturing, and comprehensive analytical testing. A dedicated Stability Center of Excellence integrating best-in-class operational standards helps ensure product efficacy.
Additionally, the new ACG mixer/granulator features a multi-blade chopper and Z-shaped impeller for better granules and shorter process times, and the machine’s unique sealing concept eliminates the need for compressed air. The unit is both ergonomic and safe; its innovative wrap-around design makes all crucial components optimally accessible to operators, while its patent-pending Maximum Operational Safety Technology™ (MOST) offers unsurpassed user protection.
“The new ACG QUEST HSM III granulator imparts flexibility to use three different size bowls to accommodate granulation batch sizes from 3kg to approximately 25kg,” said Brad Gold, Ph.D., vice president of pharmaceutical development for Metrics. “Moreover, its slip ring technology affords us the ability to measure the force acting on the rotating impeller shaft. It provides a sensitive measure of granulation endpoint and, just as important, provides scale-up data during tech transfer.”
John Carey, ACG Engineering’s international business head for developed markets, said, “Metrics’ selection of the QUEST HSM III provides ACG Engineering with a unique opportunity to debut our state-of-the-art granulation system at a world-class pharmaceutical contract development and manufacturing facility. We look forward to supporting Metrics as they continue to expand their process capabilities for development and manufacturing of oral solid dose products.”
For Metrics Contract Services, the new granulator is part of Mayne Pharma Inc.’s recent $80-million investment in the Greenville site. Infrastructure upgrades include a new 126,000-square-foot oral dose commercial manufacturing facility adjacent the existing plant, allowing the original space to dramatically grow its contract analytical laboratory, formulation development and clinical trial materials services capacity.
The expansion allows Metrics to offer customers a complete concept-to-commercialization solution in a single, contiguous site.