制剂
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我们支持寡核苷酸药物从临床前到商业化阶段的非口服制剂开发和生产。
我们先进的注射剂型开发和生产平台位于江苏无锡基地和上海外⾼桥基地。该平台为所有化学分⼦（包括⼩分⼦、寡核苷酸、多肽和复杂偶联物）提供⼀体化研发和生产解决⽅案。为了满⾜全球客户的各类需求，我们在江苏无锡基地还配备了⾼活注射剂⽣产线和⽆菌脂质纳⽶颗粒 (LNP) 车间。
我们的制剂和分析团队在注射剂药物开发⽅⾯拥有丰富的经验，涵盖从临床前研究、临床试验到商业化的全生命周期，每年进行超过 60,000 次的表征测试。
我们拥有 5 条⽣产线，配备全封闭隔离系统和⾃动化灌装线，⽀持多种剂型和灌装形式，总产能为每年 4,500 万支无菌制剂。
药物类型
- 寡核苷酸
- 偶联物
剂型
- 溶液/乳液
- 悬浮液
- 冻干粉
- 高级制剂，例如脂质体/ LNP
填充形式
- 西林瓶
- 预充针
- 卡式瓶
灭菌方式
- 无菌过滤
- 湿热灭菌
- 辐射
Our formulation teams are supported by more than a thousand of scientists and state-of-the-art facilities at our integrated drug product R&D and manufacturing facilities at Wuxi city and Shanghai Waigaoqiao site in China. Both two sites are within 2-hour drive to our oligonucleotide API site in Changzhou, providing an integrated oligonucleotide API and formulation development and manufacturing solution.
Sterile Injectable
Our injectable formulation development teams consist of experienced scientists, supporting various dosage forms – solution, emulsion/suspension, lyophilized powder and liposome in vial, pre-filled syringe and cartridge.
Our injectable manufacturing line is wholly automated in a full isolation system, designed to minimize human interventions and eliminate contamination to ensure high product quality. Read more.
Lipid Nano Particle (LNP) Platform
Our LNP platform features novel multi-channel micro-mixer for its robust scalability and reproducibility. Lipid nanoparticle with various assembly structures can be assembled by developing formulation and controlling process. Projects can be quickly scaled up from R&D to GMP clinical and commercial manufacturing phases utilizing our strong LNP technology platform and proprietary technology experience.
It is worth mentioning that the services of synthesizing and manufacturing of oligonucleotide and specific functional lipids (such as ionizable lipids and PEGylated lipids) can be also provided by us. In conclusion, WuXi STA LNP platform is an end-to-end platform, which integrates CMC development and manufacturing services for drug substance, drug product and analytical support. Read more.
⾼活注射剂药物
我们的高活无菌注射剂⽣产线位于江苏无锡的制剂生产基地。其职业接触限值 (OEL) 为 10 ng/m3。
其全封闭隔离系统与自动化灌装机，最大程度降低微生物污染和交叉污染⻛险，配备两台 20 m2 冻干机，可⽣产多种规格的液体及冻干粉。
该生产线每分钟可灌装 200 件，年产能超过 1,200 万件。
脂质纳米颗粒技术
脂质纳米颗粒 (LNP) 为寡核苷酸药物提供了⼀种新型药物输送系统。它们有助于克服输送难题，例如保护免受血清核酸酶的侵害、引发免疫反应以及靶向特定细胞或组织。
我们借助 WuXi TIDES 的一体化 LNP 服务加快您的寡核苷酸药物项目。我们提供的服务涵盖脂质发现、制剂和工艺开发、分析开发和不同规模的生产。
- 任何规模的新型脂质设计与合成
- 强⼤的可扩展性和可重复性（从 5 mL 开始）
- 粒径小（80~100 nm）且 PDI 窄（<0.10）
- 一体化制剂开发、分析、体外/体内评估
- 规模灵活可控，每批次从 10 升到 50 升不等
Formulation Development
The parenteral pre-formulation, formulation and analytical teams are located at Shanghai Waigaoqiao site and Wuxi City site, supporting parenteral projects from preclinical studies through clinical trials to commercial launch, spanning all synthetic molecules, including small molecules, oligonucleotides, peptides and complex chemical conjugates.
In addition, we also have high potency injectable labs with OEL limit of 10 ng/m3.
We support all types of dosage forms and filling formats.
Manufacturing
The state-of-the-art parenteral drug product manufacturing facilities are in Wuxi City drug product site in China and will be expanded to our Couvet site in Switzerland and Middletown Delaware site in the US.
We support various dosage forms and filling formats at any scale from preclinical to commercial manufacturing. We have 5 production lines are featuring fully enclosed isolation systems and automated filling lines, and we support high potency injectable drug product.
Clinical Supply Service
Our Clinical Supply Services (CSS) provide a fast, flexible and reliable supply of materials for your clinical trials at any stage (from Phase I to Phase IV). Utilizing our integrated CMC platform which includes services for both drug substance and drug product development, we offer our clients a seamless transition from process development and pre-formulation studies to drug product manufacturing, packaging, labeling and distribution to clinical sites globally. To add, our clinical supply services support both oral and parenteral drug products with various dosage forms and packaging solutions.
In 2023, our CSS teams supported both open-label and blinded studies from phase I to IV and executed hundreds of clinical protocols.
