WuXi Biologics' Drug Substance and Drug Product Facilities Again Approved by U.S. FDA and EMA

Rhea-AI Summary

WuXi Biologics announced regulatory approvals for its Drug Substance (DS) facilities and Drug Product (DP) facility in Wuxi, China, from the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). The MFG5 facility, with a capacity of 60,000L, and the DP2 facility received EMA GMP certificates within 10 months of starting GMP manufacturing. WuXi Biologics now holds 13 certified DS and DP facilities globally, expanding its capacity to support clients with commercial manufacturing. CEO Chris Chen emphasized the commitment to maintaining high global quality standards.

Positive

• WuXi Biologics received EMA GMP certificates for MFG5 and DP2 facilities, enhancing manufacturing capabilities.
• The MFG5 facility was approved for an innovative product by the U.S. FDA.
• WuXi Biologics now has 13 certified DS and DP facilities worldwide.
• The company supports 534 integrated client projects, including 14 in commercial manufacturing.

Negative

• None.

WUXI, China, Sept. 19, 2022 /PRNewswire/ --WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its two Drug Substance (DS) facilities and a Drug Product (DP) facility located in Wuxi city received regulatory approvals from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

After passing online Pre-Approval Inspection (PAI), WuXi Biologics received EMA GMP certificates for the commercial manufacturing of two biologics developed by global clients at its MFG4, MFG5 and DP2 facilities. This is the first time MFG5, the newest operational DS facility with a total of 60,000L capacity, and DP2, the second DP facility for vials, have been certified by the EMA, only 10 months after they were released for GMP manufacturing. The U.S. FDA also approved MFG5 to manufacture an innovative product for a global client.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We're proud that our additional DS and DP facilities have again been approved by both the U.S. FDA and EMA. It is a strong testament of the global quality standards we adhere to. We'll continue to establish our world-class quality system across all global sites to ensure that biologics are manufactured at the highest quality so that we can continue to enable our partners with a robust supply chain for the benefits of patients worldwide."

These approvals add to the previous 25 certifications from more than 10 global regulatory administrations. So far, WuXi Biologics has 13 certified DS and DP facilities on a global basis.

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.

View original content:https://www.prnewswire.com/news-releases/wuxi-biologics-drug-substance-and-drug-product-facilities-again-approved-by-us-fda-and-ema-301627740.html

SOURCE WuXi Biologics

FAQ

What recent approvals did WuXi Biologics receive for their facilities?

WuXi Biologics received regulatory approvals for its Drug Substance and Drug Product facilities from the EMA and FDA.

What is the capacity of the MFG5 facility approved by WuXi Biologics?

The MFG5 facility has a capacity of 60,000 liters.

How many certified facilities does WuXi Biologics have globally?

WuXi Biologics has 13 certified Drug Substance and Drug Product facilities worldwide.

What products are manufactured at WuXi Biologics' newly certified facilities?

Two biologics developed by global clients are manufactured at the recently certified facilities.

What does the approval by the EMA and FDA signify for WuXi Biologics?

The approvals indicate adherence to high global quality standards and enhance the company's manufacturing capabilities.