Prnewswire·2025-08-12 09:00Core Insights - WuXi Biologics has achieved fully automated continuous drug substance production at pilot scale using its WuXiUP™ platform, enhancing efficiency and flexibility for clients [1][4][6] Production Efficiency - The WuXiUP™ platform allows for non-stop 24/7 operation, minimizing manual intervention and reducing quality risks, leading to enhanced manufacturing efficiency [2] - In upstream processes, WuXiUP™ has demonstrated a total output exceeding 110 g/L over 24 days of continuous cell culture, with a peak daily yield of 7.6 g/L [2] - The downstream purification process utilizes a two-step, high-efficiency membrane chromatography system, resulting in a 5- to 10-fold increase in productivity compared to traditional methods [2][6] Quality Control - WuXiUP™ employs advanced Process Analytical Technology (PAT) for real-time monitoring of critical parameters, significantly improving manufacturing procedure control [3] - The integration of automated closed-loop control systems with PAT allows for intelligent diversion of out-of-spec samples, enhancing overall quality control [3] Technological Advancements - The platform is designed to manufacture a variety of pharmaceutical proteins, achieving 5–20 times higher productivity compared to traditional processes [5] - Notably, when scaling to 1,000–2,000 L using single-use bioreactors, WuXiUP™ achieves productivity levels comparable to traditional 10,000–20,000 L stainless steel bioreactors [6] Regulatory Success - The WuXiUP™ platform has facilitated one molecule to receive Biologics License Application (BLA) approval and 11 others to receive Investigational New Drug (IND) approvals [6]