Cambrex cleared to make pharmaceutical ingredients in High Point
Cambrex’s newly expanded pharmaceutical manufacturing facility in High Point has passed three major regulatory hurdles, allowing it to begin commercial production.
The company announced the successful completion of three pre-approval inspections of the facility by the U.S. Food and Drug Administration, Japan’s Pharmaceuticals and Medical Devices Agency and Australia’s Therapeutic Goods Administration.
The completion of all three inspections enables High Point to manufacture approved active pharmaceutical ingredients (APIs) for the United States, Japan and Australia.
“Completing these inspections demonstrates the strength of our quality systems and the dedication of the High Point team,” said Thomas Loewald, chief executive officer of Cambrex. “As more therapies are developed for targeted patient populations, the industry increasingly requires commercial manufacturing capacity at smaller scales. High Point was purpose-built to meet that need, providing customers with an efficient and flexible path from development to long-term commercial supply.”
Regulatory agencies conduct pre-approval inspections to assess a facility’s quality systems, manufacturing processes, data integrity and operational controls before commercial products can be approved for manufacture at the site.
Cambrex’s inspection approvals follow the company’s $38 million expansion of the High Point facility completed in 2023. The expansion added analytical and chemical development laboratories, a clinical manufacturing suite, and commercial manufacturing operations with reactors up to 2,000 liters.
The expansion doubled the site’s small-molecule manufacturing capacity and added about 70 new jobs.
The site is designed to support lower-volume commercial products, including orphan drugs, precision medicines, and other specialized therapies serving smaller patient populations. It complements Cambrex’s global development and manufacturing network by providing customers with a seamless path from process development and clinical manufacturing through commercial production.
Cambrex growing its N.C. presence
Cambrex, headquartered in East Rutherford, N.J., is a global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical services.
The company offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, peptide synthesis, solid-state science, biocatalysis, material characterization, complex synthetics and highly potent APIs.
Cambrex has about 2,000 employees at 14 locations across the United States and Europe.
In addition to its High Point facility, the company operates an analytical facility in Durham. Cambrex began expanding the Durham site in 2022 with 11 additional cGMP (current Good Manufacturing Practices) laboratories, broadening the company’s biopharmaceutical testing services for large molecule and viral/cell-based therapeutics.
New capabilities at the site apply to a wide variety of biopharmaceutical therapeutics, including bacteriophage and mammalian viruses, recombinant proteins, monoclonal antibodies, and nucleic acids.
The Durham facility is co-located with Q1 Scientific, a Cambrex business that provides environmentally controlled stability storage services to the pharmaceutical, medical device, and life sciences industries. Cambrex acquired Q1 Scientific in 2022.
Cambrex is owned by the global private equity firm Permira, which took the company private in a $2.4 billion acquisition in December 2019. Previously, the company’s shares were listed on the New York Stock Exchange.
Read more about Cambrex:
Cambrex to open new stability storage facility in Durham | North Carolina Biotechnology Center
Cambrex completes $38M Expansion in High Point | North Carolina Biotechnology Center