EXTON, PA — Frontage Laboratories, Inc. announced a major expansion of its early phase clinical research capabilities across the United States and China, positioning the company to meet surging demand from pharmaceutical and biotechnology firms racing to advance development programs ahead of a looming patent cliff.
The expansion strengthens Frontage’s ability to deliver accelerated, high-quality Phase I and bioequivalence studies through a growing network of clinical units and integrated services. Company officials said the move reflects mounting industry pressure to move complex programs faster while maintaining strict regulatory and scientific standards.
Frontage’s U.S. operations are anchored by a 160-bed, 36,000-square-foot Phase I clinical unit in Secaucus, New Jersey, designed to support large-scale Phase I trials, high-volume bioequivalence studies, and radiolabeled human absorption, metabolism, and excretion research. The facility is built to handle intensive early-stage programs that require rapid execution and precise data generation.
The company has further reinforced its C14-hAME capabilities with a dedicated unit staffed by licensed radiation professionals and supported by an onsite nuclear pharmacy capable of sterile and non-sterile radiolabeled compounding. Frontage said it has successfully conducted combined hAME and Absolute Bioavailability studies aligned with the FDA’s 2024 guidance, a capability that has become increasingly critical for sponsors navigating evolving regulatory expectations.
In response to rising demand for specialized oncology research, Frontage is also expanding into Oncology Phase I trials through partnerships with regional hospitals and clinical networks. The initiative enables patient-based studies across key cancer indications, extending the company’s reach beyond healthy volunteer research models.
As the pharmaceutical industry approaches a wave of patent expirations, Frontage said its multiple U.S. clinical units are positioned to manage complex, high-volume bioequivalence programs. Collaboration with Frontage China supports flexible multi-regional clinical trial execution, allowing sponsors to coordinate global timelines more efficiently.
These expanded capabilities are delivered through Frontage’s One-Stop Shop model, which integrates bioanalytical and central laboratory services, drug metabolism and pharmacokinetics, and chemistry, manufacturing, and controls. The platform also includes drug product manufacturing operations in Pennsylvania, designed to reduce handoffs, shorten development timelines, and lower overall study costs as competition intensifies across the drug development landscape.
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