制剂
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我们支持多肽药物从临床前到商业阶段的开发与生产，涵盖口服和非口服制剂。
我们的口服固体制剂开发和生产平台位于中国上海外高桥、江苏无锡市、瑞士库威和美国圣地亚哥。
位于无锡基地的注射剂开发和生产平台拥有多条生产线，年产量超过4200万支。
为了满足全球客户的多样化需求，无锡基地还配备有高活制剂平台，涵盖口服和注射剂两种剂型。
非口服给药平台
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
我们的非口服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不同阶段的项目需求，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无菌制剂生产，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
⾼活无菌注射剂
我们的⾼活⽆菌注射剂⽣产线位于江苏无锡的制剂基地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。
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 m<sup>2</sup> 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
口服制剂平台
我们支持从处方前到商业化阶段的各类口服制剂的开发和生产，包括片剂、胶囊、脂质体、粉末、颗粒和口服液等。我们目前拥有一千多名制剂研发和分析研究员，每年与数千家客户合作，加速其药物开发进程，早日惠及全球病患。借助我们的口服制剂平台，我们已成功支持了 900 多个药物开发，覆盖从临床前到商业化不同阶段。
以下是我们口服制剂平台中常见的多肽制剂开发方法：
- 方法一：口服递送（通过胃肠道吸收）
- 方法二：舌下递送（通过舌下黏膜吸收）
通过了解多肽的物理/化学和生物药剂学特性，我们通常可以应用以下策略进行口服递送：
- 渗透促进剂
- 自微乳化药物递送系统（SMEDDS）
- 其他（固体脂质纳米粒等）
通过使用上述策略，我们已经成功开发和生产了 10 多种用于各种临床研究的口服多肽制剂。
高活口服制剂
我们在江苏无锡建有高活口服固体制剂⽣产车间，无锡基地坚持全球质量标准，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，其密闭能力 (Containment Performance Target,CPT) 可达到职业暴露限值 (Occupational Exposure Limit, OEL) 低至 10 ng/m³ 的控制要求。 我们提供多种制剂工艺，包括湿法和干法制粒、胶囊填充、压片和包衣，年度总产能达 6 亿剂。
