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Adds to the company's fast-growing parenteral formulation capabilities.
September 12, 2022
By: Charlie Sternberg
WuXi STA, a subsidiary of WuXi AppTec, has opened a new sterile lipid nanoparticle (LNP) formulation development and manufacturing facility at its Wuxi city campus. Created in response to the increasing demand for complex injection dosage forms, this new facility adds to the company’s fast-growing parenteral formulation capabilities and is yet another opportunity to enable customers as they develop and deliver better medicines for patients. This new facility integrates multi-channel chip, micro-mixer system, and complex preparation system into a multi-channel micro-mixer core LNP manufacturing platform, offering significant advantages in drug-loading, liposome particle size control, and encapsulation efficiency. In addition, the modular design provides greater processing flexibility, enabling this platform to serve a wide range of manufacturing scales from 10-50 L per batch. WuXi STA’s integrated drug product platform offers a full spectrum of services, including solid-state development, pre-formulation, formulation development, and clinical to commercial drug product manufacturing with a variety of drug delivery technologies, including a broad range of oral and injectable dosage forms. This new sterile LNP platform further expands the company’s end-to-end capabilities. WuXi STA has 12 sites across the U.S., Europe and Asia that offer a wide range of services and meet global regulatory standards. Together with other development and manufacturing sites, this new platform provides considerable synergy with the company’s oligonucleotide CRDMO platform. The LNP delivery system is particularly advantageous in overcoming the bioavailability challenge of oligonucleotides and their conjugates. Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, “We are pleased to support our partners with this state-of-the-art LNP facility to meet the growing demand for advanced injection dosage forms. We will continue to expand our CRDMO platform’s capacity and capabilities to enable our partners to accelerate more innovative drugs to market for patients worldwide.”
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