WuXi Biologics' WuXiUP™ Accomplishes Automated Continuous Drug Substance Production at Pilot-Scale
WuXi Biologics (WXXWY) has announced a significant technological advancement in its WuXiUP™ platform, achieving fully automated continuous drug substance (DS) production at pilot scale. The platform demonstrates exceptional performance metrics, including 24 days of continuous cell culture with total output exceeding 110 g/L and peak daily yield of 7.6 g/L.
The enhanced platform integrates advanced features including membrane chromatography, automated control systems, and improved Process Analytical Technology (PAT). The two-step membrane chromatography system delivers a 5-10x increase in productivity compared to traditional methods. The platform will be implemented across WuXi Biologics' major GMP facilities, enabling 24/7 operation with minimal manual intervention.
WuXi Biologics (WXXWY) ha annunciato un significativo progresso tecnologico nella sua piattaforma WuXiUP™, ottenendo la produzione completamente automatizzata e continua di sostanza farmacologica (DS) su scala pilota. La piattaforma mostra metriche di performance eccezionali, tra cui 24 giorni di coltura cellulare continua con una resa totale superiore a 110 g/L e un picco giornaliero di 7,6 g/L.
La piattaforma potenziata integra funzionalità avanzate come la cromatografia a membrana, sistemi di controllo automatizzati e una migliorata Tecnologia Analitica di Processo (PAT). Il sistema di cromatografia a membrana in due fasi offre un aumento della produttività di 5–10 volte rispetto ai metodi tradizionali. La piattaforma sarà implementata nelle principali strutture GMP di WuXi Biologics, consentendo un funzionamento 24/7 con minimo intervento manuale.
WuXi Biologics (WXXWY) ha anunciado un avance tecnológico significativo en su plataforma WuXiUP™, logrando la producción totalmente automatizada y continua de sustancia activa (DS) a escala piloto. La plataforma muestra métricas de rendimiento excepcionales, incluyendo 24 días de cultivo celular continuo con una producción total superior a 110 g/L y un rendimiento diario pico de 7,6 g/L.
La plataforma mejorada integra funciones avanzadas como cromatografía de membrana, sistemas de control automatizados y una mejorada Tecnología Analítica de Proceso (PAT). El sistema de cromatografía de membrana en dos pasos ofrece un aumento de productividad de 5–10 veces frente a los métodos tradicionales. La plataforma se implementará en las principales instalaciones GMP de WuXi Biologics, permitiendo un funcionamiento 24/7 con mínima intervención manual.
WuXi Biologics (WXXWY)는 WuXiUP™ 플랫폼에서 파일럿 규모의 완전 자동 연속 의약품 원료(DS) 생산을 달성하는 중대한 기술적 진전을 발표했습니다. 이 플랫폼은 총 산출량이 110 g/L를 초과하고 일일 최고 수율이 7.6 g/L인 24일 연속 세포 배양을 포함한 탁월한 성능 지표를 보여줍니다.
향상된 플랫폼은 멤브레인 크로마토그래피, 자동 제어 시스템 및 개선된 공정분석기술(PAT)과 같은 고급 기능을 통합합니다. 2단계 멤브레인 크로마토그래피 시스템은 기존 방식에 비해 생산성이 5–10배 향상됩니다. 해당 플랫폼은 WuXi Biologics의 주요 GMP 시설 전반에 도입되어 최소한의 수작업으로 24/7 운영을 가능하게 합니다.
WuXi Biologics (WXXWY) a annoncé une avancée technologique majeure sur sa plateforme WuXiUP™, atteignant une production entièrement automatisée et continue de substance médicamenteuse (DS) à l'échelle pilote. La plateforme affiche des indicateurs de performance exceptionnels, notamment 24 jours de culture cellulaire continue avec une production totale dépassant 110 g/L et un rendement quotidien maximal de 7,6 g/L.
La plateforme améliorée intègre des fonctions avancées telles que la chromatographie sur membrane, des systèmes de contrôle automatisés et une Technologie Analytique de Procédé (PAT) améliorée. Le système de chromatographie sur membrane en deux étapes offre un gain de productivité de 5–10 fois par rapport aux méthodes traditionnelles. La plateforme sera déployée dans les principales installations GMP de WuXi Biologics, permettant un fonctionnement 24/7 avec une intervention manuelle minimale.
WuXi Biologics (WXXWY) hat einen bedeutenden technologischen Fortschritt seiner WuXiUP™-Plattform angekündigt und eine vollständig automatisierte, kontinuierliche Wirkstoff(DS)-Produktion im Pilotmaßstab erreicht. Die Plattform weist hervorragende Leistungskennzahlen auf, darunter 24 Tage kontinuierliche Zellkultur mit einer Gesamtproduktion von über 110 g/L und einem täglichen Spitzenwert von 7,6 g/L.
Die verbesserte Plattform integriert fortschrittliche Funktionen wie Membran-Chromatographie, automatisierte Steuerungssysteme und verbesserte Prozessanalytik (PAT). Das zweistufige Membran-Chromatographiesystem liefert eine 5–10-fache Produktivitätssteigerung gegenüber herkömmlichen Methoden. Die Plattform wird in den wichtigsten GMP-Anlagen von WuXi Biologics implementiert und ermöglicht einen 24/7-Betrieb bei minimalem manuellem Eingriff.
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- Building on its success in developing continuous production at pilot-scale with the WuXiUP™ platform, WuXi Biologics has further enhanced the technology to achieve automated continuous drug substance (DS) manufacturing at pilot-scale. This advancement integrates industry-leading technologies, including membrane chromatography and automated control systems, along with iterative enhancements to Process Analytical Technology (PAT).
- The WuXiUP™ automated continuous production platform will deliver greater value as it boosts manufacturing efficiency and product quality, enabling clients to accelerate the journey of their innovative therapies from development to commercialization.
By fully integrating an automated system, the continuous production platform enables non-stop 24/7 operation, which minimizes manual intervention, reduces quality risks, and enhances manufacturing efficiency. In upstream processes, WuXiUPTM has accomplished exceptional performance: 24 days of continuous cell culture yields a total output that exceeds 110 g/L, with a peak daily yield of 7.6 g/L. For downstream purification, WuXiUP™ incorporates a two-step, high-efficiency membrane chromatography system. Compared to traditional resin-based stationary phases, this technology enables faster mass transfer, delivering a 5- to 10-fold increase in productivity.
To strengthen quality control throughout downstream continuous purification, WuXiUP™ employs advanced, iteratively improved Process Analytical Technology (PAT), which provides real-time monitoring and feedback on critical parameters in Harvested Clarified Cell Culture Fluid (HCCF), including protein purity, concentration, pH, and conductivity. When integrated with the automated closed-loop control system, the technology utilizes Residence Time Distribution (RTD) analysis to intelligently divert out-of-spec samples, significantly enhancing manufacturing procedure control.
Dr. Chris Chen, CEO of WuXi Biologics, commented: "The WuXiUP™ platform has already proved its technical maturity and viability in commercial manufacturing. And now it has reached another significant milestone: accomplishing fully automated continuous DS production at pilot scale. Such achievements underscore WuXi Biologics' steadfast dedication to furthering technological innovation, and advancing the standards for digitalization and automation in biopharmaceutical R&D and manufacturing — both of which are critical capabilities to improve quality and accelerate timelines. With our deep technical expertise and extensive track record, WuXi Biologics remains committed to enabling our global clients to speed drug development more efficiently, benefiting patients worldwide."
About WuXiUPTM
WuXiUPTM is an intensified perfusion culture process developed as a next-generation biomanufacturing solution that provides high-yield, high-quality drug products while being highly flexible and cost-effective. Compared to traditional fed-batch and perfusion processes, WuXiUPTM enables the manufacturing of diverse pharmaceutical proteins, including mAb, bispecific antibody, fusion protein, and other recombinant protein, with 5–20× higher productivity.
This performance advantage is particularly notable when scaling to 1,000–2,000 L using single-use bioreactors, where it achieves productivity levels comparable to those of traditional 10,000–20,000 L stainless steel bioreactors. The WuXiUPTM platform has enabled one molecule to receive BLA approval and 11 others to receive IND approvals.
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SOURCE WuXi Biologics
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