中国上海
2023年7月17日
药明康德子公司合全药业宣布，其首条高活（High Potency）全自动隔离器无菌注射剂生产线在无锡制剂基地正式投产，年产能达1200万支注射剂，进一步提升注射剂平台能力，同时更好地满足合作伙伴在高活性药物研发和生产方面日益增长的需求。
位于无锡制剂基地的高活注射剂生产线的隔离器灌装线
该高活无菌注射剂生产车间密闭能力可达到职业暴露限值（Occupational Exposure Limit，OEL）10 ng/m3的控制要求，同时以业界领先的全隔离器灌装技术为核心，配备自动进出料系统，全流程自动化，最大程度减少人为干预，全方位避免交叉污染，为无菌产品提供坚实的质量保障。高活注射剂生产线拥有2台20 m2冻干机，可支持多种规格的西林瓶水针以及冻干粉针的生产，灌装速度可达200 支/分钟。
该车间采用全密闭设计理念，并严格按照国际制药工程协会（The International Society for Pharmaceutical Engineering，“ISPE”）要求，对密闭隔离器的密闭性进行定期工业卫生监测，同时结合独立的空调系统、袋进袋出排风净化装置等，全方位确保操作人员、环境及产品的安全。
合全药业目前已拥有2条全自动隔离无菌注射剂生产线，年产能分别为200万支注射剂、1000万支注射剂，支持西林瓶（水针及冻干粉针）、预充针及卡式瓶的无菌灌装。2024年，合全药业还将在无锡基地投产2条全新注射剂生产线。此外，公司的无菌脂质纳米粒（Lipid Nanoparticles，LNP）制剂平台也已在无锡制剂基地启用，单批产量为10 升-50 升，从而更好地支持复杂新分子，尤其是寡核苷酸药物的开发。合全药业瑞士库威制剂基地及正在建设中的美国米德尔敦制剂基地，未来几年内也将新增注射剂生产线。
注射剂平台能力的持续升级将更好地与WuXi TIDES CRDMO平台发挥协同效应，为合作伙伴提供从原料药到制剂的一体化CMC服务，支持寡核苷酸、多肽及相关复杂化学偶联药物的开发。截至目前，WuXi TIDES已承接超过30个从原料药到制剂的一体化寡核苷酸及多肽项目。在完成的项目中，平均9-10个月即可从API研发推进至IND申报，平台速度优势凸显。
合全药业在高活领域深耕多年，已具备全面的高活原料药研发与生产能力。随着高活无菌注射剂生产线投产，公司的高活制剂平台能力从口服制剂拓展至注射剂，进一步增强了一体化CMC平台能力。目前，合全药业能够为开发高活创新药的合作伙伴，提供从原料药到制剂的“端到端”服务，覆盖从临床前到商业化的药物开发全生命周期。
药明康德联席首席执行官、合全药业首席执行官陈民章博士表示：“很高兴我们的高活注射剂生产线投产，更好地满足日益增长的高活创新药开发需求。作为创新的赋能者，合全药业将继续提升CRDMO平台能力，并通过全球供应网络及符合国际标准的质量体系，助力合作伙伴加速新药开发进程，为广大患者谋求健康福音。”
关于合全药业
合全药业是药明康德子公司，在亚洲、北美及欧洲地区均设有研发及生产基地。合全药业服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合同研究、开发与生产领域（CRDMO）的领军企业，合全药业致力于为全球合作伙伴提供高效、灵活、高质量的一站式解决方案，以支持包括小分子、寡核苷酸、多肽及各种复杂化学偶联药物的研发与生产。更多信息，请访问公司网站：
WuXi STA Debuts Its First High Potency Sterile Injectable Manufacturing Line at Wuxi City Site
Shanghai, China
July 17, 2023
WuXi STA, a global Contract Research, Development, and Manufacturing Organization (CRDMO), today launched its first high potency (HP), fully automated sterile injectable manufacturing line at the drug product site in Wuxi City, China. The new HP injectable manufacturing line, with an annual capacity of 12 million units, further enhances the company’s manufacturing capabilities and capacity for injectable dosage forms. This expansion allows the company to adeptly respond to the increasing demand of the high potency pharmaceuticals market.
Fully isolated filling line at the new high potency injectable manufacturing line at Wuxi City site
Meeting Occupational Exposure Limits (OEL) as low as 10 ng/m3, the new HP injectable manufacturing line utilizes fully enclosed isolation systems and automated filling machines. This design effectively minimizes human intervention, preventing cross-contamination and ensuring stringent quality assurance for sterile products. The line is equipped with two 20 m2lyophilizers and supports liquid and lyophilized vials of various specifications, with a filling rate of up to 200 units per minute. Adhering to the International Society for Pharmaceutical Engineering (ISPE) guidelines, regular industrial hygiene monitoring is conducted to maintain the rigorous integrity of the sealed isolators. This commitment to stringent compliance, along with the integration of an independent air conditioning system and a bag-in bag-out (BIBO) exhaust air purification system, guarantees the safety of operators, the environment, and the product quality.
The Wuxi City drug product site currently has two fully automated sterile injectable manufacturing lines, with manufacturing capacity of 2 million and 10 million units annually, respectively. These lines support various dosage forms, including liquid and lyophilized vials, pre-filled syringes, and cartridges. In addition, the company’s sterile lipid nanoparticle (LNP) platform has also started operation at the Wuxi City site, with a batch production capacity ranging from 10 to 50 liters, supporting the formulation development of complex new modalities, especially oligonucleotide-based drug candidates. By 2024, WuXi STA plans to add two more injectable manufacturing lines at the same site, with additional lines also set to be added to the Couvet site in Neuchâtel, Switzerland and upcoming Middletown site in Delaware, USA.
The ongoing enhancement of the injectable platform will also effectively synergize with the WuXi TIDES CRDMO platform, providing integrated CMC solutions for both API and drug products for the development of oligonucleotides, peptides, and related complex chemical conjugates. To date, WuXi TIDES has gained experience from over 30 integrated CMC projects related to oligonucleotide and peptide drugs. The completed projects have demonstrated notable speed and efficiency advantages, typically progressing from API process development to being IND-ready within a 9-10 month timeframe.
In addition, WuXi STA has established comprehensive capabilities in R&D and production of HPAPI with many years of experience. With the launch of the new HP injectable line, combined with the HP oral drug production line, the company further enhanced its HP CMC platform that now provides an end-to-end solution including both API and drug product, seamlessly covering the entire life cycle of HP new drug development from research all the way to commercial manufacturing.
“I’m thrilled that our HP injectable R&D and manufacturing platform has achieved yet another significant milestone,”said Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA.“In addressing the growing needs of high potency drugs, WuXi STA, as an innovation enabler, will continue to strengthen our CRDMO platform capabilities. With our proven track record of consistent quality and EHS systems across all sites globally, we are committed to accelerating pharmaceutical development and bringing new therapeutics for patients worldwide.”
About WuXi STA
WuXi STA (stapharma.com), a subsidiary of WuXi AppTec (wuxiapptec.com), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier contract development and manufacturing organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate.
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