EXTON, PA — Frontage Laboratories, Inc. said its new Exton manufacturing facility has completed good manufacturing practice validation and is now fully operational, expanding the company’s clinical and commercial drug production capabilities.
The facility, which opened in May 2025 and completed GMP validation in October, is supporting ongoing Phase III clinical programs, process performance qualification batches, and small-scale commercial manufacturing. The site is designed to support sterile, oral solid, and liquid dosage forms, positioning Frontage to serve a broad range of pharmaceutical development needs.
The manufacturing complex includes GMP production rooms built to ISO classifications, containment suites for high-potency compounds, and dedicated non-sterile manufacturing areas for tablets, capsules, ointments, gels, and oral liquids. The facility also houses aseptic suites for sterile products such as vials, syringes, and cartridges, along with formulation development spaces and analytical and microbiology laboratories.
Frontage said the expansion includes significant new equipment investments, including three automated aseptic filling lines for vials, syringes, and cartridges, additional isolators for potent compound handling and sterile filling, a Gerties roller compactor, a Korsch tablet press, an Xcelodose system, and new labeling equipment. The additions are intended to improve efficiency, enhance quality controls, and shorten development timelines for pharmaceutical clients.
The company said the facility is particularly aimed at supporting small and mid-sized drug developers seeking to accelerate clinical trials or move more quickly toward commercialization by consolidating development and manufacturing services under one roof.
“With this fully operational GMP facility and newly installed commercial-scale equipment, Frontage bolsters its role as a comprehensive partner supporting faster time-to-market,” said Song Li, chairman of Frontage. He said the expanded pharmaceutical solutions platform is designed to help customers optimize cost and quality while supporting patients globally.
Frontage operates as a contract research and manufacturing organization, providing integrated services spanning drug discovery, development, and manufacturing for pharmaceutical and biotechnology companies worldwide.
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