Wuxi Biologics

WuXi Biologics is a global leader in the biologics contract development and manufacturing (CDMO) industry, offering integrated services from discovery to commercial manufacturing for biologics, vaccines, and cell and gene therapies.

WuXi Biologics operates a broad range of services, including process development, cGMP manufacturing, and comprehensive testing services. The company leverages its expertise to support clients through all stages of drug development. Their services span preclinical, clinical, and commercial manufacturing, including cell line development, analytical services, viral clearance, regulatory support, and formulation & drug product development. WuXi Biologics operates multiple high-quality facilities across the world, employing advanced technologies and quality systems to ensure the success of drug products across various therapeutic areas.

Key Products and Services:

• Cell Line Development and Characterization: In-house, compliant with global GMP regulations, ensuring efficient cell banking and characterization services.
• Drug Substance Manufacturing: Clinical and commercial-scale production of biologics from both mammalian and microbial expression systems.
• Drug Product Manufacturing: Formulation, fill, labelling, and packaging services for biologics, including parenterals, under cGMP conditions.
• Testing Services: Extensive testing capabilities, including biosafety, analytical testing, and characterization services.
• Regulatory Support: Expertise in drug filing, with a track record of INDs, BLAs, and other global regulatory submissions.

WuXi Biologics continues to expand its capabilities globally, with a focus on providing flexible, scalable solutions that support its clients' evolving needs. By integrating services across biologics and vaccines, the company is well-positioned to drive innovation in the biotech and pharmaceutical sectors.