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WuXi Biologics Honored with 2025 Global Customer Value Leadership Recognition by Frost & Sullivan
Prnewswire· 2025-10-20 09:30
Core Insights - WuXi Biologics has been awarded Frost & Sullivan's 2025 Global Customer Value Leadership Recognition in the biologics CRDMO industry, highlighting its commitment to exceptional customer value through technology innovation and operational excellence [1][2]. Company Overview - WuXi Biologics is a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) that offers end-to-end solutions for biologics, supporting clients from discovery to commercialization [7][8]. - The company employs over 12,000 skilled professionals across multiple countries, including China, the United States, Ireland, Germany, and Singapore [8]. Project Portfolio - As of June 30, 2025, WuXi Biologics has a total of 864 integrated projects, which is one of the largest portfolios in the industry, including 326 monoclonal antibodies (mAbs), 168 bispecifics & multispecifics, 225 antibody-drug conjugates (ADCs), 80 fusion proteins, and 25 vaccines [3][8]. - The development timeline for mAbs has been significantly reduced to 9 months from DNA to Investigational New Drug (IND) application, with some projects completed in as little as 6 months [3]. Manufacturing Capabilities - The company has manufactured over 300 batches using single-use technology (SUT) at scales ranging from 4,000 to 16,000 liters, achieving a 98% success rate since 2022 [3]. - SUT manufacturing costs are now comparable to traditional stainless-steel systems, enhancing cost efficiency [3]. Quality Assurance - WuXi Biologics has achieved a 100% success rate in Pre-License Inspections (PLI) and has passed 44 inspections by global regulatory agencies, including 22 by the U.S. FDA and EMA [3]. Strategic Positioning - In a rapidly evolving biopharmaceutical landscape, WuXi Biologics is positioned to lead the transformation of the CRDMO model by expanding its international presence and enhancing supply chain resilience [4]. - The company emphasizes innovation through its integrated platform, enabling clients to navigate market uncertainties with greater speed and flexibility [4]. Leadership Perspective - Dr. Chris Chen, CEO of WuXi Biologics, expressed that the recognition from Frost & Sullivan reflects the company's commitment to driving global biologics innovation and creating enduring value for its partners [5]. Sustainability Commitment - WuXi Biologics prioritizes sustainability as a cornerstone of long-term growth, focusing on green technology innovations and achieving excellence in Environment, Social, and Governance (ESG) practices [9][10].
Three WuXi Biologics Manufacturing Facilities Receive GMP Certification from Türkiye İlaç ve Tibbi Cihaz Kurumu (TITCK)
Prnewswire· 2025-09-17 04:00
Core Insights - WuXi Biologics has received GMP certification from Türkiye ilaç ve Tıbbi Cihaz Kurumu (TITCK) for three of its manufacturing facilities in Wuxi, marking the first GMP inspection by Turkey's TITCK at the company [1][2] - The certification reflects WuXi Biologics' commitment to maintaining high international quality standards across its global operations [1][4] Manufacturing and Quality Standards - The three facilities, MFG1, MFG2, and DP5, successfully passed a five-day onsite inspection for two monoclonal antibody biologics, validating the company's capabilities in delivering high-quality services [2] - WuXi Biologics has a strong track record, having passed 44 regulatory inspections, including 22 by the FDA and EMA, and holds a 100% pass rate for Pre-License Inspection by the FDA [3] Operational Capacity - The company operates 16 GMP-certified drug substance and drug product facilities globally, reinforcing its reputation for quality and compliance [3] - As of June 30, 2025, WuXi Biologics is supporting 864 integrated client projects, including 24 in commercial manufacturing [6] Leadership and Future Outlook - Dr. Chris Chen, CEO of WuXi Biologics, emphasized the importance of quality in ensuring safety and efficacy in the pharmaceutical industry and expressed commitment to maintaining high standards [4] - The company aims to leverage its first-class quality system and service capabilities to support clients in delivering high-quality biologics to patients worldwide [4] Sustainability Initiatives - WuXi Biologics prioritizes sustainability as a key component of long-term growth, focusing on green technology innovations and responsible practices [7]