US EditionWuxi Biologics Completes First Commercial PPQ Campaign at 15,000L Production Line in Hangzhou Site
- On May 16, 2025, WuXi Biologics announced that CANbridge Pharmaceuticals received regulatory clearance in China for their innovative enzyme replacement therapy, velaglucerase-beta , intended to treat Gaucher disease in patients aged 12 and older.
- This approval follows a decade of CANbridge's focus on rare diseases and leverages WuXi Biologics' integrated technology platform to advance the treatment from concept to commercialization.
- Velaglucerase-Beta represents the inaugural enzyme replacement treatment for Gaucher disease developed within China, addressing a rare genetic condition that affected approximately 3,000 individuals in the country as of 2020.
- The pivotal clinical trial met its primary endpoint showing significant spleen volume reduction at nine months , while production improvements increased yield over 110 times and enzyme activity by more than 50%.
- This milestone enables affordable and accessible domestically produced enzyme replacement therapy, highlighting WuXi Biologics and CANbridge's role in advancing rare disease therapeutics in China.
88 Articles
88 Articles
The Courier-Tribune
WuXi Biologics Congratulates Partner CANbridge Pharmaceuticals on the Approval of Innovative Velaglucerase-beta for Injection (Gaurunning) for Gaucher Disease by China NMPA
Enabled by WuXi Biologics' industry-leading integrated technology platform, velaglucerase-beta for injection has successfully advanced from concept to commercialization.Velaglucerase-beta for injection, as the first and the only locally developed enzyme replacement therapy (ERT) for Gaucher disease in China, marks a significant…
Wuxi Biologics completes first commercial PPQ campaign at 15,000L production line in Hangzhou site
WuXi Biologics ("WuXi Bio"), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced the successful completion of the first commercial project Process Performance Qualification (PPQ) campaign for its three sets of 5,000L single-use bioreactors (SUBs) in the second drug substance line of its MFG20 facility at the Hangzhou site.
Wuxi Biologics Completes First Commercial PPQ Campaign at 15,000L Production Line in Hangzhou Site
WuXi Biologics ("WuXi Bio"), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), announced the successful completion of the first commercial project Process Performance Qualification (PPQ) campaign for its three sets of 5,000L single-use bioreactors (SUBs) in the second drug substance line of its MFG20 facility at the Hangzhou site.
WuXi Biologics Reports Completion of First Commercial PPQ Campaign at 15,000 L Production Line
WuXi Biologics completed the first commercial project Process Performance Qualification (PPQ) campaign for its three sets of 5,000 L single-use bioreactors (SUBs) in the second drug substance line of its MFG20 facility at the Hangzhou site in China. The accomplishment not only marks a “significant breakthrough” as Asia’s first 5,000 L drug substance scale-up line utilizing SUBs, but also demonstrates the company’s capabilities in single-use tech…
WuXi Biologics Completes First Commercial PPQ Campaign at 15,000L Production Line in Hangzhou Site - PressReach
– The campaign marks the successful commercial-scale PPQ completion of Asia’s first 3 X 5,000L single-use bioreactors– Proprietary process innovation reduces protein cost by nearly 70% while boosting yield 20%– As the company’s largest operational single-use bioreactor to date, the system triples total site capacity to 23,000L, enabling flexible scale-up solutions HANGZHOU, China, April 18, 2025 /PRNewswire/ — WuXi Bio…
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