Frontage Laboratories, Inc., a global Contract Research, Development and Manufacturing Organization (CRDMO), announced the expansion of its early phase clinical research capabilities across the United States and China. This strategic growth enhances the company's ability to support pharmaceutical and biotech partners with accelerated, high‑quality clinical development solutions.
The company has further strengthened its C14‑hAME capabilities through a dedicated unit staffed by licensed radiation experts and supported by an onsite nuclear pharmacy for sterile and non‑sterile radiolabeled compounding. Frontage has successfully executed combined hAME and Absolute Bioavailability studies aligned with the FDA's 2024 guidance.
In response to growing industry demand, Frontage is also expanding into Oncology Phase I trials through partnerships with regional hospitals and clinical networks, enabling patient‑based research across key cancer indications.
As the industry approaches a significant wave of patent expirations, Frontage's multiple US clinical units are positioned to manage complex, high‑volume BE programs. Collaboration with Frontage China enables flexible Multi‑Regional Clinical Trial (MRCT) execution to support global program timelines.
These capabilities are integrated through Frontage's "One‑Stop Shop" model, which combines Bioanalytical & Central Lab services, DMPK, and CMC—including drug product manufacturing in Pennsylvania—to reduce handoffs, accelerate timelines, and lower overall study costs.