WuXi Biologics Advances Drug Substance Production Technology with WuXiUP™
WuXi Biologics, a prominent Contract Research, Development, and Manufacturing Organization (CRDMO), continues to stake its claim as a leader in biopharmaceutical innovations with the announcement of a major breakthrough in drug substance production. Their WuXiUP™ platform has achieved a significant milestone: fully automated, continuous drug substance (DS) production at pilot scale. This advancement stands out for its integration of sophisticated technologies, notably membrane chromatography and automated control systems, along with iterative improvements to Process Analytical Technology (PAT).
The WuXiUP™ platform’s full automation means continuous operation is not just possible but efficient, allowing factories to run 24/7 with minimal manual intervention. This minimizes risks associated with human error, thereby enhancing the overall quality of the manufacturing process. During trials, the platform demonstrated exceptional effectiveness, yielding over 110 g/L of cell culture product in a mere 24 days, alongside a peak daily output of 7.6 g/L.
Downstream purification benefits from a two-part membrane chromatography system that promises increased productivity rates—up to 10 times the output of traditional methods—by enhancing mass transfer rates. Notably, this comes as a necessary improvement since conventional processes often struggle with efficiency as production scales.
To ensure stringent quality control during this continuous purification process, WuXiUP™ has been equipped with advanced PAT systems. These allow real-time monitoring of crucial parameters, including protein purity, concentration, and other necessary metrics. By incorporating these technologies with automated control systems, WuXi Biologics can now intelligently manage out-of-spec samples through precise monitoring, thereby enhancing manufacturing control.
Dr. Chris Chen, the CEO of WuXi Biologics, highlighted the pioneering nature of the WuXiUP™ platform, stating that its proven reliability in commercial manufacturing now reaches new heights with this breakthrough in automation. The goal, as Dr. Chen emphasized, revolves around advancing technological innovation while also pushing the boundaries of digitalization and automation in the realm of biopharmaceutical research and manufacturing. This trajectory not only improves product quality but also accelerates the commercialization pathways for new therapies.
WuXiUP™ represents a next-generation biomanufacturing solution, enabling the production of a diverse range of pharmaceuticals—specifically monoclonal antibodies, bispecific antibodies, fusion proteins, and other recombinant proteins—with yield rates significantly higher than conventional production systems. When utilizing single-use bioreactors with a capacity ranging from 1,000 to 2,000 L, WuXiUP™ achieves productivity levels that can rival traditional stainless steel bioreactors. This is particularly pivotal for meeting the increasing demands of the biopharmaceutical market.
WuXi Biologics is dedicated to empowering clients in their drug development endeavors, ensuring that innovation and efficiency go hand in hand. The advancements within the WuXiUP™ platform are not just technical milestones, but they also represent a strategic foundation that aligns with the pressing need for faster pharmaceutical development timelines in a competitive global market. As the industry continues to evolve, WuXi Biologics stands ready to lead the charge, fostering an environment where patients can benefit from improved access to vital therapies more expeditiously than ever before.
The WuXiUP™ platform’s full automation means continuous operation is not just possible but efficient, allowing factories to run 24/7 with minimal manual intervention. This minimizes risks associated with human error, thereby enhancing the overall quality of the manufacturing process. During trials, the platform demonstrated exceptional effectiveness, yielding over 110 g/L of cell culture product in a mere 24 days, alongside a peak daily output of 7.6 g/L.
Downstream purification benefits from a two-part membrane chromatography system that promises increased productivity rates—up to 10 times the output of traditional methods—by enhancing mass transfer rates. Notably, this comes as a necessary improvement since conventional processes often struggle with efficiency as production scales.
To ensure stringent quality control during this continuous purification process, WuXiUP™ has been equipped with advanced PAT systems. These allow real-time monitoring of crucial parameters, including protein purity, concentration, and other necessary metrics. By incorporating these technologies with automated control systems, WuXi Biologics can now intelligently manage out-of-spec samples through precise monitoring, thereby enhancing manufacturing control.
Dr. Chris Chen, the CEO of WuXi Biologics, highlighted the pioneering nature of the WuXiUP™ platform, stating that its proven reliability in commercial manufacturing now reaches new heights with this breakthrough in automation. The goal, as Dr. Chen emphasized, revolves around advancing technological innovation while also pushing the boundaries of digitalization and automation in the realm of biopharmaceutical research and manufacturing. This trajectory not only improves product quality but also accelerates the commercialization pathways for new therapies.
WuXiUP™ represents a next-generation biomanufacturing solution, enabling the production of a diverse range of pharmaceuticals—specifically monoclonal antibodies, bispecific antibodies, fusion proteins, and other recombinant proteins—with yield rates significantly higher than conventional production systems. When utilizing single-use bioreactors with a capacity ranging from 1,000 to 2,000 L, WuXiUP™ achieves productivity levels that can rival traditional stainless steel bioreactors. This is particularly pivotal for meeting the increasing demands of the biopharmaceutical market.
WuXi Biologics is dedicated to empowering clients in their drug development endeavors, ensuring that innovation and efficiency go hand in hand. The advancements within the WuXiUP™ platform are not just technical milestones, but they also represent a strategic foundation that aligns with the pressing need for faster pharmaceutical development timelines in a competitive global market. As the industry continues to evolve, WuXi Biologics stands ready to lead the charge, fostering an environment where patients can benefit from improved access to vital therapies more expeditiously than ever before.
Topics Health）
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