Accelerating Drug Development Through WuXiUP™ Technology
Revolutionizing Drug Manufacturing with WuXiUP™
WuXi Biologics is making significant strides in the world of biopharmaceuticals with its innovative WuXiUP™ platform. Building upon its prior successes, the company has achieved remarkable advancements in continuous drug substance (DS) production at pilot scale. By integrating cutting-edge technologies such as membrane chromatography and automated control systems, WuXi Biologics is setting new standards in manufacturing efficiency and product quality.
Enhancements to the WuXiUP™ Platform
The core of WuXiUP™ lies in its automated continuous production capabilities, which provide substantial value to clients. This state-of-the-art manufacturing process accelerates the transition of therapeutic innovations from concept to market, enhancing both efficiency and product quality dramatically.
Fully Automated Continuous Production
With the implementation of a fully automated system, WuXiUP™ facilitates seamless operations around the clock. This continuous production model minimizes human intervention, thereby reducing quality risks associated with traditional methods. In the upstream phase, WuXiUP™ has demonstrated impressive outcomes: a continuous cell culture period of 24 days has yielded an output exceeding 110 g/L, alongside a peak daily yield of 7.6 g/L.
Advanced Downstream Purification
For downstream processes, WuXiUP™ utilizes a two-step membrane chromatography system that significantly enhances productivity. This cutting-edge technology allows for faster mass transfer, offering boosts in productivity ranging from five to ten times when compared to conventional resin-based phases. Such advancements support a robust manufacturing flow and are crucial for meeting market demands.
Quality Control and Monitoring
Ensuring the quality of drug substances is paramount, and WuXiUP™ rises to the challenge with advanced Process Analytical Technology (PAT). This feature enables real-time monitoring of critical parameters such as protein purity, concentration, pH, and conductivity in Harvested Clarified Cell Culture Fluid (HCCF). When combined with an automated closed-loop control system, WuXiUP™ intelligently analyzes Residence Time Distribution (RTD), effectively identifying and managing out-of-spec samples.
Commitment to Innovation
Dr. Chris Chen, CEO of WuXi Biologics, emphasizes the significance of achieving fully automated continuous DS production at pilot scale as a testament to the platform's maturity. He highlights the role of technological advancement in enhancing digitalization and automation within biopharmaceutical R&D and manufacturing. These capabilities not only improve product quality but also shorten timelines, ultimately benefiting patients seeking innovative therapies.
About WuXiUP™
WuXiUP™ is engineered as a next-generation solution in biomanufacturing, bringing forth high-yield and high-quality drug products in a flexible and cost-effective manner. Its capabilities far exceed traditional fed-batch and perfusion processes, allowing for the manufacture of various pharmaceutical proteins—ranging from monoclonal antibodies to fusion proteins—with a productivity increase of 5 to 20 times.
Scalability and Approval Achievements
This platform’s scalability is particularly impressive when drawing upon volumes of 1,000 to 2,000 liters, where single-use bioreactors match productivity levels typically associated with larger stainless-steel bioreactors of 10,000 to 20,000 liters. Notably, WuXiUP™ has successfully enabled one molecule to gain Biologics License Application (BLA) approval, with an additional eleven candidates receiving Investigational New Drug (IND) approvals.
Frequently Asked Questions
What is WuXiUP™ and how does it enhance drug production?
WuXiUP™ is an automated platform that significantly improves the efficiency and quality of drug production, allowing for continuous operations and real-time monitoring.
What are the productivity benefits of using WuXiUP™?
This platform offers 5 to 20 times higher productivity compared to traditional manufacturing methods, making it a revolutionary solution for biopharmaceuticals.
How does WuXiUP™ improve quality control?
It employs advanced Process Analytical Technology (PAT) for real-time monitoring of critical quality parameters, ensuring drug substance purity and compliance.
What types of products can be manufactured using WuXiUP™?
WuXiUP™ is capable of producing various pharmaceutical proteins, including mAbs, fusion proteins, and more, catering to diverse therapeutic needs.
What approvals have been achieved with WuXiUP™ technology?
Using WuXiUP™, one molecule has secured BLA approval, while eleven others have obtained IND approvals, highlighting its effectiveness in drug development.
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