Hangzhou, China
Biologics development and aseptic fill finish integrated facility
Thermo Fisher’s Hangzhou site combines industry-leading biologics development with aseptic formulation and manufacturing services, all under one roof. The facility leverages decades of experience in contract development and manufacturing to deliver quality mammalian biopharmaceuticals, as well as drug product forms for preclinical, early development, late phase, and commercialization.
The site is also home to our Quick to Clinic for Biologics™ solution, which enables our customers to accelerate their molecule development timelines from preclinical to IND/IMPD.
For customers who want a one-stop shop solution in China, our Hangzhou site adds drug development and manufacturing to our list of existing solutions for clinical trial supply and logistics, as well as CRO capabilities. Look no further for a truly integrated, end-to-end CRO/CDMO offering that serves China and the world beyond.
Hangzhou, China site offerings:
The 80,000-square-meter, state-of-the-art facility features sustainable construction design, flexible laboratory and production suites, integrated aseptic fill finish technology, and digital connectivity and data visibility to enable operational efficiencies. Thermo Fisher’s advanced bioproduction technologies — including single-use equipment with up to 2,000L scale — are utilized within the suites, with future investments planned for bioreactor capacity up to 5,000L scale.
Biologics development and aseptic fill finish capabilities:
- Integrated drug substance and drug product manufacturing
- In-house analytical expertise, QC, and QA
- Expertise in fed batch and perfusion process
- In-house and partnered cell line development
- Single-use technologies and flexible facility design
- Upstream and downstream process development expertise
- Prefilled syringes and prefilled cartridges
- Sterile liquid vials
- Sterile lyophilized vials
- Clinical to commercial scale filling
Drug product delivery forms at Hangzhou facility:
| Size / details | Early Development (into part of phase ll) | Late development | Commercial supply | |||||
|---|---|---|---|---|---|---|---|---|
| Liquid vials | ||||||||
| Lyophilized vials | ||||||||
| Prefilled syringes | ||||||||
| Prefilled cartridges | ||||||||
⬤ Available now
✱ Future capabilities
To learn more about the Hangzhou site’s capabilities and equipment, contact us or download the fact sheet.
Helpful Resources
Webinar
Webinar
Gateway to China: Developing Biologics for the fastest-growing patient population on Earth
Hear from Yan Fang Ma, general manager of Thermo Fisher’s site in Hangzhou, China, as she describes the opportunities and challenges multinational companies may face bringing biologics and sterile drug products to market in China and the how the right CDMO partner can provide trusted guidance along the way.
View Webinar
Whitepaper
Whitepaper
Opportunities and challenges for clinical research in China
Today China is a dominant presence in the clinical trial arena and one of the most desirable biopharmaceutical markets in the world. This whitepaper presents the opportunities—and challenges—of conducting clinical trials in China, together with proven strategies for success.
View Whitepaper
Infrographic
Infographic
CDMO checklist to launch your molecule globally
Preparing to take your drug into the global market? You’ll need to make sure your CDMO has what it takes to successfully navigate the global regulatory space with speed, security, and supply safeguards. Use this quick list as a reference when evaluating your options.
View Infographic
Case Study
Case Study
An alternative logistics approach realizes cost and performance efficiencies in Asia Pacific
A top major pharmaceutical company with research priorities aligned to significant global health needs had a high number of studies in progress in the Asia Pacific region.
View Case Study