制剂
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我们支持从临床前到商业化阶段的多肽类药物的口服和胃肠外制剂的开发和生产。
我们的口服固体制剂开发和生产平台位于上海外高桥、 江苏无锡市、瑞士库威和美国圣地亚哥。
我们的胃肠外制剂开发和生产平台位于江苏无锡，拥有多条生产线，每年产量超过 4,200 万单位。
为了满足全球客户的不同需求，我们在无锡还拥有口服和肠胃外剂型的高活制剂生产线。
肠胃外给药平台
药物类型
- 多肽
- 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
我们的胃肠外制剂开发和分析团队在注射制剂开发方面拥有丰富的经验，支持从临床前研究到临床试验再到商业化发布，每年进⾏ 60,000 多次表征测试。
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的注射剂。我们的总产能为每年 6,700 万剂。
Our peptide drug product platform offers a comprehensive formulation service for oral solid and injectable dosage forms. The 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, Shanghai Waigaoqiao site in China. Both two sites are within 2-hour drive to our peptide API site in Changzhou, providing an integrated peptide API and formulation development and manufacturing solution.
Oral Solid
Our oral solid platform provides a variety of dosage forms including tablets, capsules, powder, granules, liquid in bottle, liquid filled hard capsules and softgels with billions of doses annual capacity. In 2022, the team evaluated 2,498 molecules in preformulation studies, delivered 2,815+ clinical batches and worked on 45+ late phase and commercial projects. Read more
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
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20m2 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。
Lipid Nanoparticle Technology
Lipid Nanoparticle (LNP) is a novel drug delivery system for oligonucleotide drug to overcome its delivery challenges, such as providing protection against serum nucleases, eliciting an immune response, targeting specific cell or tissue.
Overcome delivery challenges and accelerate your oligonucleotide drug projects with WuXi STA’s end-to-end LNP services, covering lipid discovery, formulation & process development, analytical development, and GMP clinical and commercial manufacturing.
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
口服固体制剂平台
我们⽀持从处方前到商业化⽣产的各种⼝服剂型，包括⽚剂、胶囊、脂质制剂、粉末和颗粒、 口服液。我们拥有⼀千多名制剂和分析科学家，每年与数千名客户合作，加速他们为全球患者开展的药物项⽬。
- 仅需 1 克多肽原料药，即可在 8 周内完成制剂
- 我们已开发了10多种⼝服多肽制剂
高活口服制剂
我们在江苏无锡建立了高活口服固体制剂⽣产基地，无锡基地以全球高标准为高活口服药物提供制剂开发和生产服务。
我们的高活口服制剂生产车间采用全封闭生产系统和自动化设备。其控制性能目标 (CPT) 符合职业暴露限值 (OEL) 的控制要求，低至 10 ng/m3 。我们提供多种配方工艺，包括湿法和干法制粒、胶囊填充、压片和包衣。我们的产能为每年 6 亿剂。
