WuXi Biologics' WuXiUP鈩� Accomplishes Automated Continuous Drug Substance Production at Pilot-Scale
WuXi Biologics (WXXWY) has announced a significant technological advancement in its WuXiUP鈩� 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鈩�, 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 funzionalit脿 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 produttivit脿 di 5鈥�10 volte rispetto ai metodi tradizionali. La piattaforma sar脿 implementata nelle principali strutture GMP di WuXi Biologics, consentendo un funzionamento 24/7 con minimo intervento manuale.
WuXi Biologics (WXXWY) ha anunciado un avance tecnol贸gico significativo en su plataforma WuXiUP鈩�, logrando la producci贸n totalmente automatizada y continua de sustancia activa (DS) a escala piloto. La plataforma muestra m茅tricas de rendimiento excepcionales, incluyendo 24 d铆as de cultivo celular continuo con una producci贸n total superior a 110 g/L y un rendimiento diario pico de 7,6 g/L.
La plataforma mejorada integra funciones avanzadas como cromatograf铆a de membrana, sistemas de control automatizados y una mejorada Tecnolog铆a Anal铆tica de Proceso (PAT). El sistema de cromatograf铆a de membrana en dos pasos ofrece un aumento de productividad de 5鈥�10 veces frente a los m茅todos tradicionales. La plataforma se implementar谩 en las principales instalaciones GMP de WuXi Biologics, permitiendo un funcionamiento 24/7 con m铆nima intervenci贸n manual.
WuXi Biologics (WXXWY)電� WuXiUP鈩� 頂岆灚韽检棎靹� 韺岇澕霟� 攴滊鞚� 鞕勳爠 鞛愲彊 鞐办啀 鞚橃暯頀� 鞗愲(DS) 靸濎偘鞚� 雼劚頃橂姅 欷戨寑頃� 旮办垹鞝� 歆勳爠鞚� 氚滍憸頄堨姷雼堧嫟. 鞚� 頂岆灚韽检潃 齑� 靷办稖霟夓澊 110 g/L毳� 齑堦臣頃橁碃 鞚检澕 斓滉碃 靾橃湪鞚� 7.6 g/L鞚� 24鞚� 鞐办啀 靹疙彫 氚办枒鞚� 韽暔頃� 韮侅洈頃� 靹彪姤 歆�響�毳� 氤挫棳欷嶋媹雼�.
頄レ儊霅� 頂岆灚韽检潃 氅る笇霠堨澑 韥毵堩啝攴鸽灅頂�, 鞛愲彊 鞝滌柎 鞁滌姢韰� 氚� 臧滌劆霅� 瓿奠爼攵勳劃旮办垹(PAT)瓿� 臧欖潃 瓿犼笁 旮半姤鞚� 韱淀暕頃╇媹雼�. 2雼硠 氅る笇霠堨澑 韥毵堩啝攴鸽灅頂� 鞁滌姢韰滌潃 旮办〈 氚╈嫕鞐� 牍勴暣 靸濎偘靹膘澊 5鈥�10氚� 頄レ儊霅╇媹雼�. 頃措嫻 頂岆灚韽检潃 WuXi Biologics鞚� 欤检殧 GMP 鞁滌劋 鞝勲皹鞐� 霃勳瀰霅橃柎 斓滌唽頃滌潣 靾橃瀾鞐呾溂搿� 24/7 鞖挫榿鞚� 臧�電ロ晿瓴� 頃╇媹雼�.
WuXi Biologics (WXXWY) a annonc茅 une avanc茅e technologique majeure sur sa plateforme WuXiUP鈩�, atteignant une production enti猫rement automatis茅e et continue de substance m茅dicamenteuse (DS) 脿 l'茅chelle pilote. La plateforme affiche des indicateurs de performance exceptionnels, notamment 24 jours de culture cellulaire continue avec une production totale d茅passant 110 g/L et un rendement quotidien maximal de 7,6 g/L.
La plateforme am茅lior茅e int猫gre des fonctions avanc茅es telles que la chromatographie sur membrane, des syst猫mes de contr么le automatis茅s et une Technologie Analytique de Proc茅d茅 (PAT) am茅lior茅e. Le syst猫me de chromatographie sur membrane en deux 茅tapes offre un gain de productivit茅 de 5鈥�10 fois par rapport aux m茅thodes traditionnelles. La plateforme sera d茅ploy茅e 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鈩�-Plattform angek眉ndigt und eine vollst盲ndig automatisierte, kontinuierliche Wirkstoff(DS)-Produktion im Pilotma脽stab erreicht. Die Plattform weist hervorragende Leistungskennzahlen auf, darunter 24 Tage kontinuierliche Zellkultur mit einer Gesamtproduktion von 眉ber 110 g/L und einem t盲glichen 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鈥�10-蹿补肠丑别 Produktivit盲tssteigerung gegen眉ber herk枚mmlichen Methoden. Die Plattform wird in den wichtigsten GMP-Anlagen von WuXi Biologics implementiert und erm枚glicht 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听WuXiUP鈩� 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听WuXiUP鈩� 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鈩� 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鈩� 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鈩� 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 鈥� 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听
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鈥�20脳 higher productivity.
This performance advantage is particularly notable when scaling to 1,000鈥�2,000 L using single-use bioreactors, where it achieves productivity levels comparable to those of traditional 10,000鈥�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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