BioDuro is expanding its global CRDMO network with the opening of a new drug substance R&D and manufacturing campus in Bengbu, China. Additionally, high-potency labs and peptide scale-up synthesis facilities are being added to two Shanghai campuses. These developments significantly increase the company’s capacity and capabilities to meet the growing demand for scalable and integrated solutions for small molecules, peptides, and complex conjugated drugs in the biopharmaceutical industry.
Bengbu Campus: Enhanced Drug Substance Manufacturing
The newly established Bengbu campus, set to begin operations in September 2025, will strengthen drug substance manufacturing capabilities, particularly for large-scale commercial production of regulatory starting material (RSM). This investment responds to the increasing need for drug substance manufacturing capacities as pharmaceutical projects progress through clinical trials and toward commercialization.
The 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, enabling the company 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-site to facilitate process development, optimization, and scale-up, ensuring efficient technology transfer and project execution.
Continuity and Streamlined Project Flow
A common challenge in the biopharmaceutical industry is the disruption caused by transitioning drug substance manufacturing between organizations as projects mature. The Bengbu campus will offer a more continuous drug substance pathway within the service portfolio. By providing increased capacity for large-scale drug substance manufacturing, the new facility aims to reduce the need for clients to switch CMOs during late-stage development and commercialization. This approach will streamline project flow, mitigate risks associated with technology transfer, and accelerate timelines.
Shanghai Expansions: Enhancing Specialized Capabilities
In Shanghai, specialized laboratory facilities have been expanded to support high-growth areas. A new peptide scale-up production facility, equipped for kilo-gram scale Solid-Phase Peptide Synthesis (SPPS), began operations in January 2025. This facility integrates with the peptide discovery center in Beijing, enabling a seamless transition from early-stage discovery through to development and scale-up. This integration improves efficiency and timelines for peptide-based drug development.
Additionally, a high-potency synthesis laboratory, equipped with containment capabilities up to OEB-5 (OEL 0.1 µg/m3), will be operational by March 2025. This lab will support the synthesis of potent small molecule APIs and complex conjugates, including PDCs, ADCs, OPCs, and RDCs. These expansions will broaden the overall CMC portfolio, enabling the company to support a wider range of innovative therapies and emerging modalities that require specialized handling and manufacturing approaches.
Integrated CMC Platform
These strategic expansions are part of an ongoing effort to enhance the integrated CMC platform. The new Bengbu campus will significantly boost drug substance manufacturing capabilities, while the Shanghai expansions will add specialized expertise in peptides, high-potency APIs, and complex conjugates. Together with the headquarters in Irvine, California, which focuses on oral drug product development and commercial manufacturing, these developments position the company as a global leader in providing end-to-end solutions for innovative therapies and emerging drug modalities.
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