2021-08-20 13:54:39來源:藥方舟瀏覽量:927
第五屆中國生物藥CMC國際峰會
5th Annual BioCMC International Summit
2021年12月2-3日,中國·蘇州香格里拉大酒店
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參展時間:12月2-3日
蘇州駕玉生物醫(yī)藥有限公司,于2017年5月成立于蘇州工業(yè)園區(qū)內(nèi),由“中組部特聘專家“林巧博士領(lǐng)銜創(chuàng)立。公司在2019年6月被評為“姑蘇領(lǐng)軍企業(yè)”,2019年9月在上海張江開始GMP檢測業(yè)務,2021年中將完成蘇州生物檢測中心的建設。公司作為全球首家質(zhì)量管理外包服務機構(gòu)(Bio-CQO?)和第三方GMP 安全性和產(chǎn)品質(zhì)量檢測機構(gòu),已服務了國內(nèi)外20多家生物制藥企業(yè),包括中國及歐美在抗體、抗體偶聯(lián)藥物,CAR-T及其它細胞基因療法領(lǐng)域的領(lǐng)軍企業(yè)。服務內(nèi)容概括產(chǎn)品全生命周期的藥學和質(zhì)量研究及體系建設與管理,細胞庫及藥物產(chǎn)品安全性和放行檢測,全球IND到BLA的注冊申報支持等。駕玉服務的標準根據(jù)客戶需求,可以達到符合國際人用藥品注冊技術(shù)協(xié)調(diào)會(ICH)、美國藥監(jiān)局(FDA)、歐盟藥品管理局(EMA)中國等全球 GMP 要求。
JADE Biomedical. was founded in Suzhou Industrial Park May 2017 by Dr Claudia Qiao Lin, a "China National Expert” awardee by the Central Organization Department. June 2019, JADE was named "Suzhou Leading Enterprise" for its innovative business model and service scope which is to provide End-to-End Quality Services to the rapidly growing global Biopharmaceutical industry. September 2019, JADE started GMP Testing in Shanghai at Zhangjiang High-tech Park and will complete construction of their new lab facility in Suzhou Biological Testing Center early 2021.
As the world's first Contract Quality Organization (Bio-CQO?), Third-party Cell Bank and Product Safety and Release QC Testing Organization, JADE has served over 20 Biopharmaceutical companies globally, including many leading Biopharmas in China and around the world. JADE has also serviced MAHs with products including antibodies, antibody-drug conjugates, and CAR-T cell therapy. JADE Services also include pharmaceutical and quality management of whole product life cycle, product safety, and regulatory filing. According to specific needs of each customer, operational standards of JADE can meet global GMP requirements of the ICH, United States Food & Drug Administration (FDA), European Union Drug Administration (EMA), and China’s NMPA.
第五屆中國生物藥CMC國際峰會
2021年12月2-3日,中國·蘇州香格里拉大酒店
重磅報告加持!內(nèi)容再升級!日程更詳盡!
點擊上方圖片鏈接,了解更多BioCMC峰會詳情↑↑↑
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