IRVINE, CALIF., October 24, 2024 – BioDuro-Sundia, a leading global contract research, development and manufacturing organization (CRDMO), today announced the opening of a new kilo laboratory at its R&D campus, located in the Free-Trade Zone of Shanghai, China. This pilot-scale production laboratory enables scale-up synthesis for drug substance from 500 grams to kilograms, further enhancing the company's ability to accelerate more drug candidates from discovery through to preclinical and clinical phases to meet the growing demands of BioDuro-Sundia's global partners.
Equipped with large-capacity reactors, the kilo laboratory can conduct multiple synthesis batches simultaneously for improved operational efficiency. Key equipment includes high- and low- temperature jacketed reactors, and low-temperature spherical reactors, supporting complex multi-step scale-up reactions of various active pharmaceutical ingredients (API) and advanced intermediates. Furthermore, the laboratory features advanced safety evaluation instruments, such as Differential Scanning Calorimetry (DSC), which provides critical safety data to support chemists in developing safe and efficient reaction routes, seamlessly bridging medicinal chemistry research and process development.
"Our new kilogram laboratory exemplifies BioDuro-Sundia's unwavering commitment to advancing our CRDMO platform and delivering exceptional value to our global partners," said Dr. Armin Spura, CEO of BioDuro-Sundia. "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."
The opening of the new laboratory follows closely on the heels of that of a new Compound Management Center at the same site, which enabled the site to provide systematic storage, handling, and management of clients' compounds, further enhancing BioDuro-Sundia's comprehensive drug discovery capabilities.
About BioDuro-Sundia
BioDuro-Sundia, an Advent International portfolio company, is a CRDMO with a 28-year proven track record. Headquartered in Irvine, California, USA, our global presence spans 7 sites across the United States and China, with over 2,000 employees. Specializing in both small and large molecule discovery, development, scale-up, and manufacturing, we offer fully integrated services from early drug discovery to commercial manufacturing across chemistry, biology, drug metabolism and pharmacokinetics (DMPK), drug substance, and drug product.
For more information,please visit www.bioduro-sundia.com.
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