BioDuro, an contract research, development, and manufacturing organization, is expanding its global network with the opening of a new drug-substance R&D and manufacturing campus in Bengbu, China, and the addition of high-potency labs and peptide scale-up synthesis facilities in two Shanghai campuses in China. Jim Li, President, Global CMC Solutions, BioDuro, outlined the company’s expansion plans at the DCAT Member Company Announcement Forum at DCAT Week.  

The newly established Bengbu campus, set to begin operations in September 2025, is designed to enhance the company’s drug-substance manufacturing capabilities, particularly for large-scale commercial production for regulatory starting materials (RSMs). The Bengbu facility features 130,000 liters of total reactor volume distributed across eight manufacturing lines, with individual reactors reaching up to 15,000 liters. This capacity will support the production of RSMs and advanced intermediates to support drug-substance projects from Phase I through commercial supply. An integrated process R&D center, accommodating 150+ chemists, will be co-located on the Bengbu campus. This center will facilitate process development, optimization, and scale-up activities.  

In addition, the company began operations at a new peptide scale-up production facility, equipped for kilogram-scale solid-phase peptide synthesis (SPPS) in January 2025. This facility enables discovery-to-development workflows by integrating with BioDuro’s peptide discovery center in Beijing, and supports peptide synthesis for early-stage development and scale-up. Additionally, a high-potency synthesis laboratory, equipped with containment capabilities up to OEB-5 (OEL 0.1 µg/m³), became operational in March 2025. This laboratory supports the synthesis of potent small-molecule active pharmaceutical ingredients (APIs) and complex conjugates, including peptide drug conjugates, antibody drug conjugates, oligonucleotide peptide conjugates, and radionuclide drug conjugates.  

These strategic expansions are part of BioDuro’s ongoing effort to enhance its integrated CMC platform. The Bengbu campus enhances its drug-substance capabilities while the Shanghai expansions add specialized expertise in peptides, high-potency APIs, and complex conjugates. The company’s headquarters in Irvine, California, focuses on oral drug product development and commercial manufacturing.