WuXi Biologics
Offering End-to-End Solutions
WuXi Biologics offers extensive development capabilities and GMP manufacturing capacity for mRNA therapeutics and vaccines. Our expert and highly-trained team provides end-to-end services from initial plasmid DNA manufacturing to drug substance (DS) and drug product (DP) GMP production. Our GMP facilities include a microbial-based manufacturing facility with up to 300L scale fermenter for plasmid DNA production, and multiple vessels covering a wide range of reaction volumes and purification equipment for mRNA transcription and purification. In addition, state-of-the-art mRNA-LNP production systems and robotic aseptic filling systems are available for DP manufacturing. As with all of our services, the foundation of our mRNA service platform is built upon our remarkable in-house, single-sourced CMC development and manufacturing capabilities and expertise, executional excellence, and world-class quality system.
Key services include:
Our GMP services include a manufacturing facility with up to 300L scale fermenter for plasmid DNA production and various volume vessels and purification equipment for mRNA transcription and purification.
Our DP service include state-of-the-art mRNA-LNP production systems (e.g. Microfluidic and T-Junction mixing techniques) as well as robotic aseptic filling systems.
Drug Product Development
Drug Product Manufacturing
Our dedicated team of highly trained and experienced analytical and QC professionals, allows us to offer:
Our established global quality system, quality control and operational systems meet or exceed worldwide regulatory standards from the U.S. FDA, EMA, NMPA and other major regulatory agencies. Our commitment to quality is ingrained in our company culture and our employees. We have harmonized our quality assurance (QA) and quality management system across all sites around the world for the clinical or commercial production of biologics and vaccines drug substance and drug product.