WuXi Biologics Completes GMP Inspection by South Korea's Ministry of Food and Drug Safety for Drug Substance Facility

Rhea-AI Summary

WuXi Biologics has successfully completed a remote GMP inspection by South Korea's Ministry of Food and Drug Safety for its drug substance facility in Wuxi. This marks the completion of 23 regulatory inspections by major agencies, demonstrating compliance with global standards. The facility utilizes an innovative production approach combining multiple bioreactor harvests for efficient manufacturing. The company is involved in 480 integrated projects and plans to exceed 430,000 liters of production capacity by 2024 across multiple countries, reinforcing its commitment to high-quality biologics and sustainability.

Positive

• Successful completion of GMP inspection enhances credibility with regulatory agencies.
• Innovative production method may lead to lower costs and higher ROI.
• Current involvement in 480 integrated projects indicates strong business activity.
• Plans to increase production capacity to over 430,000 liters by 2024 demonstrates growth potential.

Negative

• None.

• WuXi Biologics completes the first GMP inspection in 2022, demonstrating the company's premier quality system is in full compliance with global regulatory requirements.

WUXI, China, Jan. 17, 2022 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced that it has completed a remote GMP inspection by South Korea's Ministry of Food and Drug Safety for its drug substance facility (MFG2) in Wuxi city. So far, WuXi Biologics has successfully completed 23 regulatory inspections conducted by multiple regulatory agencies including U.S. FDA, EMA and China NMPA.

The comprehensive inspection was conducted by two inspectors and covered the facility's quality processes and entire production system. MFG2 facility implements the pioneering approach of combining multiple 2,000L bioreactor harvests to enable production runs up to 12,000L (i.e. "scale-out" instead of "scale-up"), a strategy that accelerated construction timeline with significantly lower CAPEX investment and higher Return on Investment (ROI), and eliminated challenges brought by traditional scale-up method. All WuXi Biologics' sites across the U.S., Europe and China follow the consistent quality system to ensure high-quality products manufactured for the partners worldwide.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are excited that we start off the year 2022 by completing the first regulatory inspection successfully. Our world-class quality system certified by major regulatory agencies is a strong testament of the highest global quality standards we adhere to. We are very motivated by the fact that the products manufactured by WuXi Biologics have helped treat patients in multiple countries and regions. WuXi Biologics will continue enabling global partners to deliver life-saving treatments quickly and effectively to the markets, with the aim of benefiting patients worldwide."

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company's history and achievements demonstrate its commitment to providing a truly ONE-stop service offering and strong value proposition to its global clients.

The company is currently conducting on behalf of its clients and partners (as of December 31, 2021) a total of 480 integrated projects, including 268 in pre-clinical development stage, 171 in early-phase (phase I and II) clinical development, 32 in late-phase (phase III) development and 9 in commercial manufacturing. With a total estimated capacity of exceeding 430,000 liters for biopharmaceutical production planned after 2024 in China, Ireland, the U.S., Germany, and Singapore, WuXi Biologics will continue to provide its biomanufacturing partners with a robust and premier-quality global supply chain network.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of its ethos and business strategy and aims to become a global ESG leader in biologics manufacturing. We use next-generation clean biomanufacturing technologies and utilize cleaner energy sources. We have also established an ESG committee led by the CEO to increase efficiency while advancing our commitment to sustainability. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

Contacts

Media
PR@wuxibiologics.com

Investors
IR@wuxibiologics.com

View original content:https://www.prnewswire.com/news-releases/wuxi-biologics-completes-gmp-inspection-by-south-koreas-ministry-of-food-and-drug-safety-for-drug-substance-facility-301462389.html

SOURCE WuXi Biologics

FAQ

What is the significance of WuXi Biologics completing the GMP inspection?

Completing the GMP inspection boosts WuXi Biologics' credibility and compliance with global regulatory standards, ensuring their products meet high-quality requirements.

How many regulatory inspections has WuXi Biologics completed?

WuXi Biologics has successfully completed a total of 23 regulatory inspections by various agencies, including the U.S. FDA and EMA.

What innovative method does WuXi Biologics use in production?

WuXi Biologics employs a scale-out production method that combines multiple 2,000L bioreactor harvests, resulting in an efficient manufacturing process.

What are WuXi Biologics' production capacity plans?

WuXi Biologics plans to surpass 430,000 liters of biopharmaceutical production capacity by 2024 across several countries.

What is WuXi Biologics' involvement in the industry?

As of December 31, 2021, WuXi Biologics is conducting a total of 480 integrated projects in various stages of development, showcasing its extensive engagement in the biologics sector.