WuXi Bio opens fill-finish facility in China

WuXi Biologics has launched the operation of its drug product facility in Wuxi, China increasing pre-filled syringes (PFS) capacity to 17 million units annually.

Contract development manufacturing organization (CDMO) WuXi Bio’s latest DP facility, named DP5, includes an advanced isolator filling line used for steady and continuous filling services. The firm says that this offers different volume delivery options for PFS, such as 1 mL Long, 1 mL, 2.25 mL, and 3 mL.

“The design of operation area, material flow, personnel flow and utilities have been optimized to improve manufacturing efficiency. Sensitive product protection can be achieved by temperature-controlled mixing system, yellow background light, etc,” Chris Chen, CEO of WuXi Biologics told BioProcess Insider.

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The CDMO claims the filling speed can reach 400 PFS per minute to support 17 million syringes of drug products production every year. Additionally, the company says this increase in capacity provides global customers with quicker and more secure end-to-end drug product services for their products at various scales and stages.

“Pre-filled syringes have emerged as one of the fastest-growing choices for biologics dosage form as our partners seek new and more convenient biologics delivery methods. The GMP operation of DP5, our first commercial drug product facility for pre-filled syringes, not only demonstrates our commitment to global partners, but also marks an important milestone for WuXi Biologics to become one of the global leaders in drug product CDMO services,” said Chen.

“We’ll continue to enable our clients to advance innovative biologics towards clinical trials, regulatory approvals, and commercialization to benefit patients worldwide.”

Furthermore, WuXi Bio says DP5’s design, single-use technology, and automated equipment drastically decreases the risk of contamination and maintains aseptic control, which is required during the filling process.  In turn, this supports product scale-up to commercial capability and ensures delivery to patients under the highest quality standards.

Chen would not disclose financial details of the facility but he did tell us that “DP5 hires over 50 staffs in manufacturing sector. In addition, a group of more than 20 scientists will provide support on process tech transfer, process trouble shooting and process performance qualifications.”

The CDMO says with the launch of this facility it has secured “a global manufacturing network” through having nine DP plants for PFS in China and Germany. In other news, with over 10% of the biologics outsourcing market share, an analyst named WuXi Bio as the second largest CDMO in March.