#China #Wuxi #WuXi Biologics #GMP Certification #bispecific antibody

WuXi Biologics Receives GMP Certification from South Korea's MFDS

WuXi Biologics, a globally recognized Contract Research, Development, and Manufacturing Organization (CRDMO), has marked a significant milestone by obtaining Good Manufacturing Practice (GMP) certification from the Ministry of Food and Drug Safety (MFDS) in South Korea. This achievement pertains to three of its state-of-the-art manufacturing facilities located in WuXi, namely Drug Substance Facility 5 (MFG5), Drug Product Facility 2 (DP2), and the Drug Product Packaging Center (DPPC).

The certification is a testament to WuXi Biologics’ dedication to adhering to the highest standards of quality and compliance in the manufacturing of bispecific antibodies, which are deemed essential for treating biliary tract cancers. This certification will enable WuXi Biologics to provide comprehensive commercial manufacturing services that cover both drug substance creation and drug product development.

During a thorough five-day inspection process, the MFDS evaluated all three facilities and found no critical or major areas of concern, underscoring WuXi Biologics' robust quality assurance systems and its proven capability to conduct large-scale manufacturing operations that comply with GMP regulations.

Importance of GMP Certification

The GMP certification positions WuXi Biologics as a key player in the biopharmaceutical sector, allowing the company to extend its end-to-end manufacturing capabilities. This development signifies WuXi's ability to efficiently supply innovative biologic therapies, not only within South Korea but across the Asia-Pacific region. As Dr. Chris Chen, the CEO of WuXi Biologics, noted: "Receiving GMP certification from the MFDS demonstrates our continued commitment to the global standards of quality and regulatory compliance."

This expanded role supports WuXi Biologics' mission to accelerate the delivery of innovative biologics to patients globally. With a track record of successful outcomes, WuXi has undergone 46 regulatory inspections, including assessments by prestigious bodies such as the FDA and EMA, maintaining a 100% pass rate for FDA Pre-License Inspections.

Continuous Commitment to Quality

WuXi Biologics' commitment to quality is reflected in its extensive global GMP manufacturing network, which has 15 GMP-certified facilities. The successful compliance with rigorous quality standards and the effective oversight of large-scale biologic programs have garnered the trust of clients worldwide. With over 1,800 GMP quality audits conducted successfully by various global stakeholders, including over 230 assessments from EU Qualified Persons, WuXi Biologics stands as a leader in biomanufacturing.

Beyond regulatory compliance, WuXi Biologics emphasizes sustainability as a cornerstone of its long-term growth strategy.

Looking Ahead

With renewed capabilities following the MFDS certification, WuXi Biologics is poised to further enhance its partnerships and support for clients involved in developing complex biologics, including bispecific antibodies. The company aims to integrate advanced technologies to streamline operations while fostering positive social and environmental impacts throughout its supply chain.

WuXi Biologics shows no signs of slowing down and is determined to support the journey from drug discovery to commercial production. By leveraging cutting-edge digital tools and infrastructure, WuXi can provide transparent client experiences, faster development times, intelligent operations, and more efficient manufacturing processes. As of the end of 2025, the company is supporting 945 integrated client projects, reflecting a strong commitment to innovation.

For more information about WuXi Biologics and its extensive portfolio of services, visit www.wuxibiologics.com.