Core 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]

Core Viewpoint - WuXi Biologics has launched the WuXia293Stable platform, enhancing the development and manufacturing of complex biologics with high titers, stability, and quality [1][6]. Group 1: Platform Features - WuXia293Stable is designed for innovative, difficult-to-express molecules, demonstrating high titers of up to 5.0 g/L for monoclonal antibodies while improving purity [4][10]. - The platform maintains stable expression and consistent quality during long-term cell passages, enabling scalable clinical and commercial manufacturing at 2000L for fed-batch and 1000L for perfusion [4][10]. - It offers a comprehensive suite of services, including cell bank testing and viral clearance validation, as part of its one-stop CMC solution [4]. Group 2: Comparison with CHO Cells - Traditionally, CHO cells have been used for recombinant protein expression but may face challenges with complex modalities, leading to low titer levels and truncation issues [2]. - HEK293 cells, utilized in WuXia293Stable, can alleviate truncation issues while maintaining high titer levels, making them more suitable for complex molecules [2]. Group 3: Company Commitment and Vision - The launch of WuXia293Stable reinforces WuXi Biologics' commitment to technological innovation and the vision that every biologic can be made [6]. - The WuXia™ platform family, which includes WuXia293Stable, has generated over 1000 cell lines for various therapeutic applications, showcasing its proven track record [7][8].