- First GMP facility in WuXi Biologics to use robotic aseptic filling line for biologics
- Demonstrated diverse and flexible aseptic filling capability while maintaining high-quality and controlled filling accuracy as well as aseptic assurance
WUXI, China, April 27, 2020 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that its robotic aseptic filling isolator facility (DP4) has successfully completed the filling of two batches of pre-filled syringes (PFS).
Using Vanrx SA25 to fill the two batches, each needle's speed reached 30 vials per minute with an acceptance rate of up to 99.1%. The whole process was performed using the robotic filling isolator in a closed system without gloves or human intervention, delivering high-quality and controlled filling accuracy, as well as improved aseptic assurance.
WuXi Biologics' DP4 is able to fill and close multiple container types, including vials, PFS and cartridges. Changeover between two different tooling sets can be completed within one hour. With low downtime between batches, this facility can be effective at both clinical and commercial quantities. It also introduces ready-to-use and disposable materials to simplify the preparation process and to reduce the risk of cross contamination. Since its GMP launch in July 2019, DP4 has successfully completed 13 batches of drug product filling and passed six audits with no critical findings. Inspectors included former U.S. FDA officers and EU Qualified Persons.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "Featuring modularization, robotic automation and a closed system, this state-of-the-art line reflects our leadership in biologics manufacturing innovation. DP4 has demonstrated our diverse aseptic filling capabilities, maintaining high product quality and extensive flexibility to serve the complex biologics filling needs of our clients. WuXi Biologics will continue to invest in cutting-edge technologies to fulfill our mission, enabling global partners to advance product approvals for the benefits of patients worldwide."
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop and manufacture biologics from concept to commercial manufacturing. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2019, there were a total of 250 integrated projects, including 121 projects in pre-clinical development stage, 112 projects in early-phase (phase I and II) clinical development, 16 projects in late-phase (phase III) development and one project in commercial manufacturing. With total estimated capacity for biopharmaceutical production planned in China, Ireland, the U.S., Germany and Singapore exceeding 280,000 liters by 2022, we will provide our biomanufacturing partners with a robust and premier-quality global supply chain network. For more information on WuXi Biologics, please visit www.wuxibiologics.com.
SOURCE WuXi Biologics