新加坡
无菌制剂开发与生产
新加坡无菌制剂灌装工厂
赛默飞在新加坡新建了领先的无菌制剂开发和生产工厂，为不断扩大的生物制药市场提供快速灌装疫苗和其他治疗药物。
在新加坡经济发展局 (EDB) 的大力支持下，赛默飞在新加坡建成了一家新工厂，壮大了赛默飞的全球网络。目前，赛默飞制药服务全球网络中已涵盖了六家可进行无菌生产与无菌灌装的工厂。
新工厂的建成进一步提升了我们满足全球科研人员需求的能力，而且扩大了我们的生物医学研究、开发和商业化网络。
工厂提供的服务
- 新工厂占地 24,000 平方米，厂内设有一条高速、全自动大小分子无菌灌装生产线。
- 配备了一次性制备系统，而且还能自定义从小规模工艺开发到大规模临床批次的工艺放大过程。
- 建设了洁净室、实验室、仓库和协助生产的办公室。
- 建厂时考虑到了灵活性和可拓展性，工厂还能再增加 14,000 平方米的空间，以满足客户不断增加的需求。
- 扩大了灌装生产线的规模，而且提高了预灌封注射器和预灌封卡式瓶、小规模工艺开发和临床试验灌装生产线、商业化无菌冻干生产线和商业包装能力。
如需详细了解工厂提供的独特服务，请点击下载工厂资料页。
工厂能力
现有能力
- 夹套罐和一次性生物工艺袋技术（最高容量为 1,000L）
- 一次性技术与灵活的工厂设计
- 厂内质控 (QC) 能力
- 无菌注射液剂 (SVP)
- 活病毒灌装能力
生物制药
- 商业化规模灌装
- 工艺开发/小规模灌装
- 包装
未来能力
- 无菌冻干制剂
- 预灌封注射器
- 预灌封卡式瓶
药物剂型
| 剂型 / 细节 | 早期开发阶段 (进入到临床II期部分阶段) | 后期开发阶段 | 商业化供应 | |||||
|---|---|---|---|---|---|---|---|---|
| 临床II期 | ||||||||
| 液体西林瓶 | ||||||||
| 冻干西林瓶 (新增) | ||||||||
| 预灌封注射器 (新增) | ||||||||
| 预灌封卡式瓶 (新增) | ||||||||
⬤ 现有能力
✱ 未来能力
如需详细了解新加坡工厂或预约工厂参观，请通过以下方式联系我们。
相关资源
Infographic
Inforgraphic
10 Reasons Formulation Complexity is on the Rise in Steriles
Within early development, there are a variety of different challenges that hinder a molecule’s ability to progress to the next phase such as complex formulation. The complexity of sterile drug development has been on the rise, which is driven by a variety of different factors.
View Infographic
Whitepaper
Whitepaper
Switching delivery formats: A lifecycle management strategy for sterile injectables
Switching delivery formats can be an effective strategy to enhance they lifecycle of your drug. This whitepaper provides insight into the benefits and challenges of transferring a therapeutic compound from one aseptic injectable format to another.
View Whitepaper
Site Location
Site Location
Hangzhou, China
Thermo Fisher’s new 80,000-square-meter current Good Manufacturing Practices (cGMP) facility offers integrated clinical and commercial drug substance and drug product capabilities, including process development, cell line development, biologics drug substance manufacturing and aseptic fill-finish.
Learn more about this site's capabiltiies.
Site Location
Site Location
Brisbane, Australia
The Thermo Fisher Scientific site in Brisbane, Australia is a state of the art facility, specializing in clinical and commercial manufacturing, and single use biologics technology. The Brisbane facility won the ISPE “2014 Facility of the Year” for Process Innovation, and is part of our global network of Biologics sites, which also includes St. Louis Missouri and Groningen, Netherlands.
View Site Location
Site Location
Site Location
Singapore (Clinical trial services)
Singapore is a hub to the Asia Pacific region due to its strategic location at the crossroads of international trade and shipping routes and its free trade policy.
Our highly experienced local Singapore team is supported by our network of Asia Pacific facilities, including Beijing & Suzhou in China, Japan, India and Korea, providing access to a global network with a local presence.
View Site Location