#China #Wuxi #WuXi Biologics #Türkiye İlaç #TITCK

WuXi Biologics Achieves Significant GMP Certification Milestones

Overview of the Certification

WuXi Biologics, a respected name in global biopharmaceutical services, has successfully garnered Good Manufacturing Practice (GMP) certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK) for three of its manufacturing plants located in Wuxi, China. This groundbreaking development, announced on September 17, 2025, not only reflects the company’s adherence to rigorous international quality standards but also marks the first time Turkey's health authorities have conducted a GMP inspection at WuXi Biologics.

The Facilities Under Certification

The facilities designated as MFG1, MFG2, and DP5 underwent a detailed five-day evaluation process during which their capabilities to produce monoclonal antibody biologics were scrutinized. The successful completion of this comprehensive assessment signifies WuXi Biologics’ unwavering commitment to providing top-notch biopharmaceutical development and manufacturing services to its global clientele. Each of these facilities has a proven track record, previously earning approvals from other prominent regulatory bodies, which enhances WuXi Biologics' reputation as a leading Contract Research, Development, and Manufacturing Organization (CRDMO).

Historical Performance and Compliance

WuXi Biologics has established itself as a firm that consistently meets the highest industry standards. As of June 2025, the organization had navigated through 44 inspections from regulatory authorities, including 22 from the FDA and the EMA. Furthermore, the company boasts an impressive 100% pass rate for Pre-License Inspections (PLI) conducted by the FDA, alongside successfully passing over 1,700 GMP quality audits from clients globally, including more than 200 by EU Qualified Persons. Currently, WuXi Biologics operates 16 GMP-certified drug substance and drug product facilities within its extensive operational network.

Insight from Leadership

Dr. Chris Chen, CEO of WuXi Biologics, expressed his delight at receiving the GMP certification from TITCK, emphasizing it as a substantial recognition in the Turkish market. He stated, "We understand that quality is crucial for ensuring safety and efficacy in the global pharmaceutical industry. This certification indicates our steadfast commitment to maintaining the highest standards across our global operations." Dr. Chen also highlighted the organization’s aim to continue enhancing its quality systems and exceptional service capabilities, reinforcing its dedication to assisting clients in delivering high-quality biologic products to patients around the world.

Commitment to Sustainability and Future Endeavors

WuXi Biologics continues to prioritize sustainability as a cornerstone for long-term growth. The organization remains focused on driving green technology innovations to provide cutting-edge Green CRDMO solutions for its global partners. With a strong commitment to environmental, social, and governance (ESG) principles, WuXi Biologics actively seeks to create shared value and foster positive impacts across the healthcare value chain. As of mid-2025, the firm supports 864 integrated client projects, including 24 that are currently in commercial manufacturing operations.

Conclusion

As the biopharmaceutical industry rapidly evolves, WuXi Biologics stands at the forefront, demonstrating a proactive approach to compliance and quality. The recent GMP certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu not only enhances its credibility but also paves the way for increased opportunities in emerging markets like Turkey. This achievement underscores the company’s enduring commitment to excellence and patient-centric solutions in the biopharmaceutical sector.