BioDuro Opens Solid-Phase Peptide Synthesis Scale-Up Facility in Shanghai

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The contract research, development, and manufacturing organization (CRDMO) BioDuro announced on Jan. 9, 2025 the opening of a fully automated solid-phase peptide synthesis scale-up laboratory at its Zhangjiang High-Tech Park campus in Shanghai, China (1). In the press release detailing the launch, BioDuro said the state-of-the-art, kilogram-scale lab would support peptide synthesis scale up to 800 mmol.

Created in response to what the company said is growing demand from global partners for efficient, scalable peptide manufacturing, the facility’s equipment includes automated solid-phase peptide synthesizers, cleavage systems, and freeze-drying equipment, designed to produce a range of molecules including both linear and cyclic peptides and peptide-drug conjugates (1).

“Demand for peptide-based programs has increased considerably, and the opening of this new laboratory provides BioDuro’s customers with a significant step forward in addressing the capabilities required to scale their candidates to compete in this fast-growing field,” Armin Spura, PhD, CEO of BioDuro, said in the press release. “We remain committed to continuously advancing our CRDMO capabilities and capacity, driving breakthroughs that deliver life-changing therapies to patients worldwide.”

BioDuro said the new laboratory complements its existing peptide discovery synthesis center in China, which is at the CRDMO’s Beijing campus (1). There, the focus is on early-stage research and development. Meanwhile in Shanghai, the new laboratory will enable a “seamless” integration, according to the press release, of projects from the discovery to development stages.

BioDuro’s comprehensive peptide platform integrates biology with drug metabolism and pharmacokinetics services, which the company said has the ultimate effect of accelerating peptide development (1).

Specialists on the chemistry teams at both the Beijing and Shanghai campuses, BioDuro said, are well-versed in both solid- and liquid-phase peptide synthesis, which from a client perspective provides additional levels of flexibility and customization (1).

In October 2024, BioDuro, which is headquartered in Irvine, Calif., announced the launch of a pilot-scale production laboratory enabling scale-up synthesis for drug substances from 500 grams to kilograms, on the same site where earlier that month, the company had said it was opening its new Compound Management Center (2,3). At the time, these facilities were said to be joining a group of BioDuro sites that altogether employ a total workforce of more than 2000.

At CPHI Milan 2024, Pharmaceutical Technology® Europe spoke with Kevin Li, MBA, about BioDuro-Sundia’s role in integrated services, and the benefits such services can provide to pharma companies.

“One side can handle both drug substance and drug product, and one side can handle the pre-formulation, formulation development, until commercial manufacturing, everything in one side,” Li said in the interview, “so that integrated solution can really help customers to accelerate their innovation through multiple benefits” (4).

References

1. BioDuro. BioDuro Opens New Solid-Phase Peptide Synthesis Scale-Up Facility. Press Release. Jan. 9, 2025.
2. BioDuro-Sundia. BioDuro-Sundia Launches New Kilogram Laboratory to Speed Development from Discovery to Preclinical and Clinical Phases. Press Release. Oct. 24, 2024.
3. BioDuro-Sundia. BioDuro-Sundia Launches New Compound Management Center, Strengthening Drug Discovery Services. Press Release. Oct. 2, 2024.
4. Thomas, F. CPHI Milan 2024: Highlighting the Benefits of Integrated Services. PharmTech.com, Oct. 25, 2024.