WuXi Biologics has completed its first scale-up to 2,000L drug substance (DS) GMP manufacturing

• WuXi Biologics successfully scaled its WuXiUI™ platform to 2,000L GMP manufacturing, achieving a 4-fold increase in productivity and a 50% reduction in downstream processing time.

• The platform’s advancements in efficiency, including a significant reduction in manufacturing costs and waste generation, position it as a robust solution for global biologics production.

WuXi Biologics has announced the successful scale-up of its proprietary WuXiUI™ platform to 2,000L GMP manufacturing, marking a significant milestone in biologics production. This achievement, which utilises the company’s ultra-intensified fed-batch bioprocessing technology, has resulted in a fourfold increase in productivity, with titers reaching 18 g/L—an impressive improvement over conventional processes.

The WuXiUI™ platform, introduced in 2023, was developed to enhance the efficiency and productivity of various mammalian cell lines used in therapeutic protein and antibody production. The platform has now proven its capability to scale from bench levels to 2,000L, confirming its robustness and readiness for larger-scale manufacturing.

In addition to the upstream benefits, the platform’s downstream technology has doubled purification processing capacity while reducing processing time by 50%. This has not only improved final drug substance yields to 70% but also significantly lowered manufacturing costs. Furthermore, the platform’s efficiency gains extend to environmental benefits, including a 30-50% reduction in material and consumable usage, leading to decreased waste generation.

Dr. Chris Chen, CEO of WuXi Biologics, commented on the achievement, stating, “The successful application and achievement of WuXiUI™ is a result of our relentless pursuit of technology innovation to speed up biologics development while achieving cost efficiency for global clients.” He added that the milestone strengthens the company’s ability to support clients in delivering high-quality, cost-effective biologics to market, ultimately benefiting patients worldwide.