BioDuro-Sundia Opens New Kilogram Laboratory at Shanghai Site

In a press release on Oct. 24, 2024, the contract research, development, and manufacturing organization (CRDMO) BioDuro-Sundia, headquartered in Irvine, Calif., said it was launching a new, pilot-scale production laboratory that will enable scale-up synthesis for drug substance from 500 grams to kilograms (1). The laboratory is located at BioDuro-Sundia’s R&D campus in the Free-Trade Zone of Shanghai, China.

The kilo laboratory, according to BioDuro-Sundia, is equipped with large-capacity reactors allowing the company to simultaneously conduct multiple synthesis batches, in the interest of improving operational efficiency (1). Other key equipment includes both high- and low-temperature jacketed reactors, low-temperature spherical reactors, and advanced safety evaluation instruments—among them, differential scanning calorimetry, which collects safety data that informs the development of safe, efficient reaction routes, the press release said.

"Our new kilogram laboratory exemplifies BioDuro-Sundia's unwavering commitment to advancing our CRDMO platform and delivering exceptional value to our global partners," said Armin Spura, PhD, CEO of BioDuro-Sundia, in the press release (1). "This state-of-the-art facility enables us to scale up production with greater speed and flexibility, expediting the journey of drug candidates from discovery to the clinic, and ultimately helping to address critical unmet medical needs."

Taken as a whole, BioDuro-Sundia said, the features of the kilo laboratory are designed to support complex, multi-step scale-up reactions of select APIs as well as advanced intermediates (1). The company said that as the demands of its partners continue to grow, the opening of the laboratory enhances BioDuro-Sundia’s ability to accelerate a greater number of drug candidates and, as Spura said, to do so from discovery through preclinical and clinical phases, building a bridge between medicinal chemistry research and process development.

The new kilo laboratory is on the same site as BioDuro-Sundia’s Compound Management Center, the launch of which was announced earlier in October 2024 (2). With real-time temperature and humidity controls, the center has the ability to manage more than 400,000 compounds, either solid or liquid, and is equipped with a liquid handling station for fully automated workflows, while sample management software tracks steps at every point of the lifecycle. Services able to be offered include storage, weighing, dissolution, plating, liquid chromatography–mass spectrometry (LC–MS) analysis, and distribution.

At CPHI Milan 2024, Pharmaceutical Technology^® Europe spoke with Kevin Li, MBA, about BioDuro-Sundia’s role in the area of 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” (3).

You can view the full interview with Li here.

References

1. BioDuro-Sundia. BioDuro-Sundia Launches New Kilogram Laboratory to Speed Development from Discovery to Preclinical and Clinical Phases. Press Release. Oct. 24, 2024.
2. BioDuro-Sundia. BioDuro-Sundia Launches New Compound Management Center, Strengthening Drug Discovery Services. Press Release. Oct. 2, 2024.
3. Thomas, F. CPHI Milan 2024: Highlighting the Benefits of Integrated Services. PharmTech.com, Oct. 25, 2024.