WuXi Biologics Released a New cGMP Drug Product Manufacturing Facility to Support End-to-End Services for Diversified Modalities

Excerpt

With further capacity and capability for drug product fill & finish, WuXi Biologics provides global customers with end-to-end integrated solutions for diversified modalities, including mRNA-LNP.

Article Summary

WuXi Biologics announced its new drug product (DP) facility, named DP8 – located in Hangzhou, China, has completed the first batch of GMP manufacturing. The DP8 facility is the tenth operational drug product facility in WuXi Biologics’ global network.

 

DP8 facility is single-use-system-based features SA25 robotic, sterile filling technology with two completely segregated filling lines, as well as an aseptic formulation isolator dedicated to the preparation of alum-adjuvanted vaccines. With mRNA-LNP encapsulation technologies, a processing capacity of 10 L per hour, the DP8 facility provides flexible dosage forms, including vials (2R to 20R) and prefilled syringes (1 mL to 3 mL, long and normal). 

 

WuXi Biologics can provide end-to-end solutions from DNA to drug substance manufacturing and drug product fill & finish for various modalities – such as enzymes, antibody fragments, recombinant proteins, virus-like particle (VLP), plasmid DNA and mRNA, combining the DP8 facility with the company’s operational development labs and drug substance facility (MFG14) located in the same area.

 

Dr. Chris Chen, CEO of WuXi Biologics, “The successful first batch of GMP manufacturing at our DP8 facility represents an important milestone for WuXi Biologics. It demonstrates that we can provide our customers with a stronger foundation to deliver drug product – including mRNA LNP – within our global manufacturing network. We look forward to supporting more partners on their paths to commercialization for the benefit of patients worldwide as we continue to expand our capabilities and capacity for end-to-end integrated drug product solutions.”

 

About WuXi Biologics

WuXi Biologics is a global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop, and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide. With over 10,000 skilled employees in China, the United States, Ireland, Germany, and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development, and manufacturing solutions. As of the end of 2021, WuXi Biologics is supporting over 480 integrated client projects, including nine in commercial manufacturing.

 

(Source: WuXi Biologics, 23th October 2022)

 

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