中国上海,2024年10月25日 — 保诺-桑迪亚,一家值得信赖的全球化合同研究、开发和生产公司(CRDMO)今日宣布,其位于中国上海外高桥研发中心的新的公斤级实验室正式启用。该中试生产实验室可支持药物从500(g)到千克(kg)级的放大合成,结合保诺-桑迪亚一体化的药物化学、药理学、药代动力学能力平台,将加速从苗头化合物发现到临床前化合物筛选的研发进程,更好地满足全球合作伙伴日益增长的定制化需求。

该公斤级实验室配备了大容量反应釜,可以同时进行多批次合成,显著提高效率。主要设备包括高低温夹套反应釜和低温球釜,可以满足各种活性药物成分(API)和高级中间体的复杂多步放大反应。此外,实验室还配备了先进的安全评估仪,如差示扫描量热仪(DSC),提供实验安全性数据,助力工艺化学家开发出安全、高效的工艺路线,从而无缝衔接药物化学研究与工艺开发。
“我们新的公斤级实验室充分展现了保诺-桑迪亚坚定不移地推进我们CRDMO平台的决心,并始终致力于为全球合作伙伴创造更高价值,”保诺-桑迪亚首席执行官苏一名(Armin Spura)博士表示。“这个新实验室将使我们能够更快、更灵活地扩大生产,加快候选药物从研发直至临床的进程,并最终帮助解决医疗领域关键性的未满足需求。”
新实验室的启用紧随新建的化合物管理中心之后,同在外高桥研发园区。新的化合物管理中心可为客户提供系统化地储存、处理和管理化合物,进一步增强保诺-桑迪亚的综合药物发现能力。
关于保诺-桑迪亚
保诺-桑迪亚,安宏资本旗下投资企业,拥有28年的历史,是一家值得信赖的全球化合同研究、开发和生产公司(CRDMO)。公司总部位于加州尔湾,在中国和美国设有7个研发生产中心,在全球拥有2000多名员工。我们专注于小分子和大分子的药物发现、开发、放大和生产服务,为生物技术和制药企业提供从早期靶点确证到商业化生产的整合服务,涵盖化学、生物学、药代动力学、原料药和成品药等多个领域。保诺-桑迪亚专注CRDMO服务,在全球化质量标准体系下运营,提供先进、快速和灵活的定制服务,以满足生物技术和制药企业的专属需求,加快新药开发进程。
更多信息,请访问公司官网http://www.bioduro-sundia.cn
BioDuro-Sundia Launches New Kilogram Laboratory to Speed Development from Discovery to Preclinical and Clinical Phases
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.Explosion Proof Double Layer Glass Reactor"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.BioDuro-Sundia, an Advent International portfolio company, is a trusted, leading contract research, development, and manufacturing organization (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, DMPK, drug substance, and drug product. Dedicated to our integrated CRDMO platform, BioDuro-Sundia operates under a single global standard, delivering fast, integrated, and customized services to meet the unique needs of our clients worldwide.For more information, please visit http://www.bioduro-sundia.com上海外高桥 | 上海张江 | 美国加州 | 无锡 | 河北 | 北京 | 蚌埠
从原料药到药品,从发现到开发,从小分子到生物制剂,保诺-桑迪亚是您的合作伙伴,可加快您的项目并提高候选药物成功的效率。

• 保诺-桑迪亚启用新化合物管理中心,升级药物研发服务|Bilingual
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