- Frontage Laboratories has completed GMP validation for its new manufacturing facility, which is now fully operational for Phase III, PPQ and small-scale commercial production.
- The facility supports sterile and non-sterile dosage forms and expands the company’s CDMO capabilities for clinical and commercial drug manufacturing.
Frontage Laboratories, Inc. has completed GMP validation for its new manufacturing facility, which opened in May 2025 and became fully operational in October 2025. The site is currently supporting ongoing Clinical Phase III programmes, process performance qualification batches and small-scale commercial manufacturing.
The facility is dedicated to drug development and clinical and commercial manufacturing across sterile, oral solid and liquid dosage forms. It includes GMP manufacturing rooms meeting ISO classifications, containment suites for high-potency compounds, non-sterile manufacturing suites for tablets, capsules, ointments, gels and oral liquids, and aseptic suites for sterile products such as vials, syringes and cartridges. The site also houses formulation development rooms, analytical laboratories and microbiology laboratories.
As part of the expansion, Frontage installed three automated aseptic filling machines for vials, syringes and cartridges, two additional isolators for potent compound handling and aseptic filling, and new equipment including a roller compactor, tablet press, Xcelodose system and labelling capabilities. The company stated that these investments support efficiency, quality and reduced timelines for drug development and contract manufacturing.
The expanded capabilities are intended to support customers, particularly small and mid-sized pharmaceutical companies, seeking to accelerate clinical development or market entry. Frontage noted that the integration of advanced technologies with its quality management system provides an end-to-end manufacturing solution.
“With this fully operational GMP facility with newly installed commercial scale equipment and systems, Frontage bolsters its role as a comprehensive partner, supporting clients to achieve faster time-to-market by managing every step of the pharmaceutical development and manufacturing process.”
Dr. Song Li, Chairman of Frontage
