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Tuesday 28 Apr 2020 , 6:42 am

WuXi Biologics Completes PFS Filling at its Robotic Aseptic Filling Facility

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%.
By SIN Bureau
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WuXi Biologics, a company with 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."

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