Tuesday, October 25, 2022
WuXi Biologics, a leading global Contract Research, Development and Manufacturing Organization (CRDMO), 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.
The single-use-system-based DP8 facility 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. It also has mRNA-LNP encapsulation technologies, with 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).
Combining the DP8 facility with the company's operational development labs and drug substance facility (MFG14) located in the same area, 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 – within a centralized region.
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."