Utilizing Single-Use Technologies Allowed to Facility Start-up within 18 Months of Ground Breaking
“Sartorius Stedim Biotech’s performance surpassed our expectations”
“We now have a highly flexible facility with scalable, disposable equipment from 50 L to 2,000 L, designed to meet the rapidly changing requirements of our clients”
Dr. Ge Li, Chairman and CEO
Quick Info
Success criteria:
- 100% closed single-use technology for pre-/ clinical trials material
- cGMP standards of the US, EU and China
- Cell culture platform for multi-host mammalian cell lines
- Multi-product capability
- Flexible, plug-and-play production scale
Project duration:
- 18 months
Solutions Provided:
- Process Simulation to size equipment
- Conceptual, Basic and Detailed Design of USP and DSP
- Automation based on DCU and MFCS
- Execution and Commissioning
Key Achievements
Multi-Product Facility
Wuxi AppTec’s challenge was to design and build a highly flexible, cost-effective, multi-product facility for monoclonal antibody production within a very challenging timeline. Wuxi AppTec involved the SSB Integrated solutions bioprocess consultant team early on in the discussions.
Decoupling Bioprocess from Facility
The team carried out risk assessments to evaluate the relative impact of traditional (re-usable) versus single-use technologies. In addition, they estimated the reduction in the project timeline from decoupling the process design from the facility build through single-use system selection. Process modelling was carried out to evaluate equipment sizing and opportunities for downsizing in utilities and for meeting higher classification room requirements by working with single-use technologies.
“Comparing the equipment investment, the total investment cost of the single-use technology was 62% lower than with traditional technology in addition, we have a highly sustainable facility.” - WuXi AppTec’s SVP Chris Chen
“Sartorius Stedim Biotech’s performance surpassed our expectations,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “We were delighted with the efficiency of SSB’s project management and with their expertise in single-use process implementation. We now have a highly flexible facility with scalable, disposable equipment from 50 L to 2,000 L, designed to meet the rapidly changing requirements of our clients. We are proud to be the manufacturer of the first biologics produced in China for clinical trials in the United States.”
Award winning facility
The WuXi AppTec bulk cell culture production facility received an honorable mention in the 2014 Facility of the Year ISPE Awards. The ISPE judging panel commented, “The design and construction execution details of this facility align with the most stringent expectations that any biopharmaceutical manufacturer would expect in regions of the world with 20 years of experience in this industry.”
WuXi AppTec’s SVP Chris Chen pointed out, “Comparing the equipment investment, the total investment cost of the single-use technology was 62% lower than with traditional technology. Comparing the key consumables, the single-use technology saved 141,000 liters of WFI, 205,500 liters of purified water and 148 kilograms of steam in every batch of production compared to stainless steel systems. So, in addition, we have a highly sustainable facility.”
Background Information
Established in December 2000, WuXi AppTec is a leading outsourcing company, providing discovery, development, and manufacturing services for small molecules, biologics and medical devices. With operations in China and the United States, WuXi offers a unique integrated R&D platform, including end-to-end biologics services from target identification to IND preparation to clinical and commercial cGMP manufacturing. WuXi has the 1st cGMP biologics manufacturing facility in China compliant with US, European and Chinese regulatory standards.
