WuXi Biologics
Offering End-to-End Solutions
WuXiUPTM
Ultra-High Productivity Continuous Processing
Achieve 5 – 15X Greater Productivity
The WuXiUPTM platform is an intensified perfusion culture process developed as a next-generation biomanufacturing solution that provides high-yield, high-quality drug products while being highly flexible and cost-effective. This platform adopts continuous harvest to greatly reduce the product residence time, which leads to high product quality.
As an integrated, intensified, continuous biologics manufacturing technology platform, WuXiUPTM drives improved economics, flexibility and quality, and is ideal for both labile or difficult-to-express proteins, as well as mAbs, bispecific Abs, Fc-fusion proteins and other recombinant proteins. WuXiUPTM has been applied to multiple projects at WuXi Biologics, providing comprehensive evaluation of this platform technology.
Other Features of WuXiUPTM Platform Include:
- Couples continuous upstream process with continuous direct product capture using multicolumn chromatography system operating in a periodic countercurrent (PCC) mode
- Dedicated DeltaV control system (Finesse) for celculture process and AKTA PCC chromatography systems and BioSMB system for purification
- Can be developed rapidly or converted from traditional fed-batch process without delaying CMC timelines
Benefits & Capacities WuXiUPTM Processing Platform
WuXiUPTM enables the manufacture of different types of pharmaceutical proteins with significantly higher productivity than can be achieved using traditional fed-batch and traditional perfusion culture. This is especially true as the process is scaled to 1,000 – 2,000 L using disposable bioreactors where similar productivity is obtained as if using traditional 10,000-20,000 L stainless steel bioreactors.
WuXiUPTM platform resulted in not only higher productivity but also significantly reduced resin amount usage and allows for a smaller facility footprint. All these factors lead to dramatic cost savings on a batch-production basis.
A summary of the advantages of WuXiUPTM technology platform over traditional fed-batch mode include:
- Achieve ultra-high productivity for all kinds of pharmaceutical proteins with high cell densities and high viability within similar production culture timelines
- Tunable glycan and charge variance profiles, usually with reduced HMW (high molecular weights) and LMW (low molecular weights) variants than in traditional processes
- Able to reduce media consumption and resin amount to effectively reduce commercial manufacturing costs
- Expedite product launch while lowering a company’s capital and operating costs
Currently our development labs can support 10+ programs simultaneously up to 15 L scale for WuXiUPTM process development.. Our non-GMP pilot plant and GMP pilot plant are able to support large scale manufacturing for WuXiUPTM at 50L to 1,000L scales.
For commercial manufacturing, we provide over 20,000L manufacturing capacity for WuXiUPTM platform, and this platform can be implemented at multiple global sites in China and Ireland, at scales from 200L to 2,000L.
In addition to WuXiUPTM, we are also capable of process intensification at different process stages. For example, we can intensify the seed train at N-1 stage with perfusion culture and achieve much higher seeding density for production using regular fed-batch culture. This results in much higher productivity and improved facility capacity under relatively simplified process settings.
Further, the intensified and continuous upstream process in our platform is also compatible with flexible product harvest steps used in either continuous or batch harvest mode.. Depending on the nature of the product and downstream facility fit, WuXiUPTM allows for a customized process to meet your protein production requirements.