Frontage Laboratories Expands Early Phase Clinical Capabilities in US and China

COMPANY PROFILE
  • Frontage Laboratories, Inc. has expanded its early-phase clinical research capabilities across the United States and China.
  • The expansion strengthens Phase I, bioequivalence, oncology, and multi-regional clinical trial support through integrated services.

Frontage Laboratories, Inc. has announced the expansion of its early-phase clinical research capabilities across the United States and China. The move is intended to support pharmaceutical and biotech companies with accelerated clinical development services across multiple regions.

In the United States, Frontage’s operations are centered on a 160-bed, 36,000-square-foot Phase I clinical unit in Secaucus, New Jersey. The facility is designed to conduct large-scale Phase I and bioequivalence studies, as well as radiolabeled human absorption, metabolism, and excretion research. The company has also expanded its C14-hAME capabilities with a dedicated unit supported by licensed radiation professionals and an on-site nuclear pharmacy.

Frontage reported that it has completed combined hAME and absolute bioavailability studies in alignment with the FDA’s 2024 guidance. In parallel, the company is expanding into Oncology Phase I trials through partnerships with regional hospitals and clinical networks, enabling patient-based research across multiple cancer indications.

As patent expirations increase industry demand for complex bioequivalence programs, Frontage’s multiple US clinical units are positioned to manage high-volume studies. Coordination with Frontage China enables multi-regional clinical trial execution to support global development timelines.

These clinical services are integrated through Frontage’s “One-Stop Shop” model, which combines bioanalytical and central laboratory services, DMPK, and CMC activities, including drug product manufacturing in Pennsylvania. As a CDMO offering contract manufacturing alongside clinical services, the company aims to reduce handoffs, shorten timelines, and manage overall study costs.

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