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

Rhea-AI Summary

WuXi Biologics has announced the completion of its new drug product facility DP8 in Hangzhou, China, which has successfully manufactured its first GMP batch. This facility is the tenth in WuXi's global network and features advanced technologies including SA25 robotic filling and mRNA-LNP encapsulation. The DP8 facility enhances WuXi's ability to provide end-to-end integrated solutions for diverse drug modalities. WuXi supports 534 integrated projects, signaling robust growth in its operations.

Positive

• Successful completion of DP8 facility with GMP manufacturing capabilities.
• Advanced technologies including SA25 robotic filling and mRNA-LNP encapsulation improve operational efficiency.
• The company supports 534 integrated client projects, indicating strong demand for services.

Negative

• None.

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

HANGZHOU, China, Oct. 23, 2022 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), 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."

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading 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 June 30, 2022, WuXi Biologics is supporting 534 integrated client projects, including 14 in commercial manufacturing.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com

Contacts

Media 
PR@wuxibiologics.com 

Business
info@wuxibiologics.com

View original content:https://www.prnewswire.com/news-releases/wuxi-biologics-released-a-new-cgmp-drug-product-manufacturing-facility-to-support-end-to-end-services-for-diversified-modalities-301656720.html

SOURCE WuXi Biologics

FAQ

What is the significance of WuXi Biologics' new DP8 facility?

The DP8 facility enhances WuXi's capacity for drug product manufacturing and supports diverse modalities, including mRNA-LNP, crucial for modern therapeutics.

When was the first batch of GMP manufacturing completed at WuXi Biologics DP8?

The first batch of GMP manufacturing at the DP8 facility was completed on October 23, 2022.

How many operational drug product facilities does WuXi Biologics have?

WuXi Biologics now has ten operational drug product facilities globally.

What types of technologies are incorporated in the DP8 facility?

The DP8 facility features SA25 robotic sterile filling technology and mRNA-LNP encapsulation technologies among others.

What is the processing capacity of the DP8 facility?

The DP8 facility has a processing capacity of 10 L per hour.