Frontage Labs Expands Early Phase Clinical Capabilities

Frontage Laboratories, Inc., a global Contract Research, Development and Manufacturing Organization (CRDMO), expanded its early phase clinical research capabilities across the U.S. and China. This expansion aims to enhance the company’s ability to support pharmaceutical and biotech partners with accelerated, high‑quality clinical development services.

The company’s U.S. operations now include a 160‑bed, 36,000‑sq.‑ft. Phase I clinical unit in Secaucus, NJ, designed to conduct large‑scale Phase I and Bioequivalence (BE) studies as well as radiolabeled human AME research. The company 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.

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.

Frontage’s U.S. 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 combined Bioanalytical & Central Lab services, DMPK, and CMC—including drug product manufacturing in Pennsylvania—to reduce handoffs, accelerate timelines, and lower overall study costs.