#China #Shanghai #WuXi Biologics #ISO 13485 #Drug-Device

WuXi Biologics Attains ISO 13485 Certification

WuXi Biologics, a prominent Contract Research, Development, and Manufacturing Organization (CRDMO), has announced a major milestone by achieving ISO 13485:2016 certification. This certification underscores the company's ability in the realm of drug-device combination products, marking WuXi Biologics as one of the pioneering companies within China’s sector to secure such a recognition. The company's commitment to upholding high standards is exemplified by its achievement of zero non-conformities during the certification process, showcasing a robust quality management system designed to enhance product safety and reliability.

The ISO 13485:2016 standard is recognized globally as a benchmark for quality assurance in the medical device industry. It establishes a structured framework that guarantees safety and efficacy through regulatory compliance throughout the product's lifecycle. The framework encompasses key components such as design and development processes, risk management, manufacturing process oversight, traceability, and supplier control. Notably, drug-device combination products must meet stringent stability requirements for pharmaceutical components while adhering to performance standards set for medical devices. WuXi Biologics has adeptly integrated these prerequisites into its operational protocols, reinforcing its commitment to both pharmaceutical and medical device regulatory demands.

During a rigorous five-day on-site audit, WuXi Biologics exemplified a solid foundation of systems and showcased comprehensive quality management strategies tailored specifically for drug-device combination products. This successful audit culminated in certification, validating the company's framework for commercial manufacturing as both dependable and effective.

Dr. Chris Chen, the CEO of WuXi Biologics, remarked, "Achieving ISO 13485 certification signifies our profound technical acumen and unwavering dedication to quality management in drug–device combination products. We are committed to maintaining stringent quality benchmarks and reliable operations to provide our global partners with safe, efficient, and high-quality solutions. This will ultimately empower the advancement of transformative therapies through a reputable CRDMO platform."

In addition to this certification, WuXi Biologics has also fortified its sustainability and regulatory compliance systems. The company has established an integrated management framework that incorporates information security, business continuity, quality control, environmental safety, energy management, and responsible procurement practices. This commitment has led to the attainment of multiple international certifications, including ISO/IEC 27001, ISO 22301, ISO 9001, ISO 14001, ISO 45001, ISO 50001, ISO 14064, and ISO 20400.

WuXi Biologics offers a comprehensive suite of end-to-end solutions designed to facilitate the discovery, development, and commercialization of biologics for patients worldwide. With a workforce exceeding 13,000 employees across various countries including China, the United States, Ireland, Germany, and Singapore, WuXi Biologics is well-equipped to handle diverse client needs through advanced technology and innovation.

As of December 31, 2025, WuXi Biologics supports 945 integrated client projects, which includes 74 in Phase III and 25 in commercial manufacturing, with complex modalities comprising more than half of its entire project portfolio. This highlights the company’s significant role in the biopharmaceutical landscape.

Sustainability remains a pivotal aspect of WuXi Biologics' operational ethos. The company actively drives innovative technologies to offer advanced Green CRDMO solutions, demonstrating exemplary Environmental, Social, and Governance (ESG) practices. Through collaboration with stakeholders, WuXi Biologics aims to create a shared value that fosters positive social and environmental impacts while promoting responsible practices across the entire value chain.

For further details about WuXi Biologics, visit www.wuxibiologics.com.