WuXi Biologics completes first commercial PPQ run for single-use bioreactor system in China
WuXi Biologics has completed its first commercial Process Performance Qualification (PPQ) campaign for three 5,000-liter single-use bioreactors at its MFG20 facility in Hangzhou, China.
The milestone marks the successful scale-up of drug substance manufacturing using single-use technology (SUT) in Asia’s first 15,000-liter configuration, according to the announcement, which it contends reinforces the company’s manufacturing capabilities for large-scale biologics production.
The company said the PPQ campaign achieved significant process efficiencies, including a 70% reduction in protein production costs and a 20% increase in yield per batch, according to the announcement. The newly installed 5,000L reactors, commissioned in 2024, are WuXi Biologics’ largest single-use bioreactors in operation. With integration alongside four 2,000L systems at the same site, the total production capacity at MFG20 has expanded from 8,000L to 23,000L.
The company said it has completed over 300 scaled batches using SUT across global facilities, reporting a 99% production success rate over the past three years. WuXi Biologics CEO Chris Chen in a statement emphasized that the technology enables cost of goods comparable to stainless-steel systems, while offering operational flexibility and reduced environmental impact.
The MFG20 site is certified under ISO 14001 and ISO 45001 standards, with a record of 100% PPQ success across multiple programs, according to the company. Its production lines are also integrated with the co-located DP9 facility for commercial-scale drug product filling, supporting vial and syringe formats.
Last month, WuXi Biologics reported that its 2024 revenue grew 9.6% year-over-year with non-COVID revenue increasing 13.1% compared to 2023, which the company attributed in part to leveraging existing and newly expanded capacities — including the ramp-up of manufacturing sites in Europe.
In last month’s 2024 earnings announcement, WuXi Biologics said it continues the expansion of MFG11 in Worcester, Massachusetts — one of the largest SUT facilities in the U.S. — which features six 6,000L upstream tanks connected to a single downstream line, with high-throughput processing and extensive automation.
Chen in a presentation in January at the JPM25 conference in San Francisco said the Chinese-based contract research, development and manufacturing organization (CRDMO) expects to see an acceleration in revenue growth in 2025, despite the looming BIOSECURE Act. WuXi Biologics is among five China-based biotechnology companies named in the bill, which seeks to prevent U.S. federal funds from supporting certain Chinese biotech “companies of concern.”