▎药明康德/报导
合全药业寡核苷酸公斤级出产车间正式投入运营
我国上海，2020年1月3日——药明康德子公司合全药业今天宣告，其坐落常州市的寡核苷酸质料药公斤级出产车间正式投入运营。这一重要里程碑标志着合全药业可以为全球客户供给寡核苷酸质料药从临床前到商业化的一站式工艺开发及出产服务，赋能客户推进寡核苷酸的立异疗法提前进入市场，谋福全球病患。
▲寡核苷酸公斤级组成操作间
近年来，核酸药物的研讨逐步成为全球立异药范畴的抢手方向，更有多款核酸药物获FDA同意上市。为了协助客户加快新药上市，合全药业不断加强寡核苷酸渠道建造。此次投入运营的出产车间面积为2800平方米，坐落于合全药业常州质料药研制及出产一体化基地。投产后，常州基地的寡核苷酸质料药单批组成规划最大将会上升到1摩尔（mol），可以更好地满意客户日益增长的需求。
现在合全药业的寡核苷酸渠道可以支撑各种类型的寡核苷酸产品，如脱氧核糖核酸（DNA），核糖核酸（RNA）和吗啉代反义寡核苷酸（PMO）以及多肽共轭的吗啉代反义寡核苷酸（PPMO）等。此外，合全药业依托其业界抢先的小分子工艺研制及出产渠道，在处理杂乱的寡核苷酸与其他分子方式的偶联化学，以及创始固相、液相相结合的新一代寡核苷酸组成技能方面具有独特优势。
“借助于合全药业小分子CMC（化学、出产和操控）渠道的规划优势、技能才能以及契合全球规范的质量体系，咱们为寡核苷酸新药开发者供给了强壮的一站式赋能渠道。”合全药业首席执行官陈民章博士表明，“此次公斤级出产车间正式投入运营，将协助全球客户将更多的寡核苷酸药物提前面向商业化，谋福全球病患。”
现在，合全药业常州基地可为全球客户供给包含小分子、寡核苷酸和多肽等多种分子方式的质料药从临床前到商业化的工艺研制及出产服务。该基地近年来还屡次经过包含美国食品药品监督管理局（FDA）及我国国家药品监督管理局（NMPA）的查看，具有契合国际规范的质量体系。
关于合全药业
合全药业是在中美两地均有运营的药明康德子公司，服务于生命科学职业，具有杰出的化学立异药研制和出产的才能和技能渠道。作为全球新药协作研讨开发出产范畴（CDMO）的领军企业，合全药业致力于为全球协作伙伴供给从临床前到商业化，高效、灵敏、高质量的一站式CMC（化学、出产和操控）解决方案。更多信息，请拜访公司网站：elerate new drugs to market, WuXi STA is continuously strengthening its oligonucleotide platform. The new facility, with over 30,000 square feet, is located at WuXi STA's Changzhou site. With its operation, the Changzhou site can manufacture oligonucleotide APIs up to 1 mol/synthesis run, to better meet the increasing demand of our customers.
WuXi STA's comprehensive platform covers the development and manufacturing of a variety of oligonucleotide modalities including DNA, RNA, Morpholino oligonucleotide (PMO) and peptide conjugates (PPMO). In addition, the company's industry-leading small molecule process chemistry organization adds further value in handling complex conjugation chemistry that involves oligonucleotide and other molecular modalities, as well as a combination of solid and solution phase chemistry to support next-generation oligonucleotide manufacturing technology development.
"By leveraging our small-molecule CMC (Chemical, Manufacturing, and Control) technology and capability platform as well as global standard quality system, WuXi STA provides a robust one-stop shop for oligonucleotide innovators. The opening of this large scale manufacturing facility will empower more global partners to expedite the development and commercialization of oligonucleotide drugs to benefit patients worldwide," commented Dr. Minzhang Chen, CEO of WuXi STA.
WuXi STA's Changzhou site can now provide services involving small molecule, oligonucleotide and peptide process R&D and manufacturing from laboratory to commercial scales. During the past years, it has successfully passed multiple inspections from the U.S. Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA), adhering to the highest regulatory standards.
about WuXi STA
STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for integrated CMC (Chemical, Manufacturing, and Control) solutions from preclinical to commercial uses. For more information, please visit: http://ess platform is enabling more than 3,700 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that "every drug can be made and every disease can be treated." Please visit: http://
