WuXi Biologics Achieves Major Milestones at Ireland Site with Multiple 16,000L PPQ Success and HPRA GMP Authorizations
WuXi Biologics announced significant achievements at its Dundalk, Ireland facility, including successful completion of multiple 16,000-liter Process Performance Qualification (PPQ) runs and GMP approvals from HPRA for all three manufacturing facilities. The site achieved two PPQ runs with 100% success rate using innovative single-use technology, combining four 4,000-liter bioreactors to match the performance of traditional stainless-steel systems.
The facility, operational since March 2022, employs over 760 people and features three manufacturing suites: a 6,000L perfusion suite and a 48,000L fed-batch suite. The site received the ISPE Facility of the Year Award in 2023 and holds ISO certifications for energy management, environmental management, and occupational safety.
WuXi Biologics ha annunciato risultati significativi presso il suo stabilimento di Dundalk, in Irlanda, inclusa la completa realizzazione di molteplici corse di Qualificazione delle Prestazioni di Processo (PPQ) da 16.000 litri e approvazioni GMP da parte di HPRA per tutti e tre gli stabilimenti di produzione. Il sito ha conseguito due corse PPQ con un tasso di successo del 100% utilizzando un'innovativa tecnologia monouso, combinando quattro bioreattori da 4.000 litri per eguagliare le prestazioni dei tradizionali sistemi in acciaio inox.
Lo stabilimento, operativo da marzo 2022, impiega oltre 760 persone e dispone di tre suite di produzione: una suite di perfusione da 6.000L e una suite di fed-batch da 48.000L. Il sito ha ricevuto il premio ISPE Facility of the Year nel 2023 e possiede certificazioni ISO per la gestione dell'energia, la gestione ambientale e la sicurezza sul lavoro.
WuXi Biologics anunció logros significativos en su instalación de Dundalk, Irlanda, incluyendo la exitosa finalización de múltiples ejecuciones de Calificación de Desempeño del Proceso (PPQ) de 16,000 litros y aprobaciones GMP de la HPRA para las tres instalaciones de fabricación. El sitio logró dos ejecuciones de PPQ con una tasa de éxito del 100% utilizando tecnología innovadora de un solo uso, combinando cuatro bioreactores de 4,000 litros para igualar el rendimiento de los sistemas tradicionales de acero inoxidable.
La instalación, operativa desde marzo de 2022, emplea a más de 760 personas y cuenta con tres suites de fabricación: una suite de perfusión de 6,000L y una suite de alimentación en lote de 48,000L. El sitio recibió el premio ISPE Facility of the Year en 2023 y posee certificaciones ISO para la gestión de la energía, la gestión ambiental y la seguridad laboral.
우시 생물학(WuXi Biologics)은 아일랜드 던달크에 있는 시설에서 다수의 16,000리터 공정 성능 검증(PPQ) 실행을 성공적으로 완료하고, 세 개의 제조 시설에 대한 HPRA의 GMP 승인을 포함하여 중요한 성과를 발표했습니다. 이 사이트는 전통적인 스테인리스 스틸 시스템의 성능을 맞추기 위해 4,000리터 바이오리액터 4개를 결합한 혁신적인 단일 사용 기술을 사용하여 100% 성공률로 두 번의 PPQ 실행을 달성했습니다.
이 시설은 2022년 3월부터 운영되었으며 760명 이상을 고용하고 있으며, 6,000L 퍼퓨전 Suite와 48,000L fed-batch Suite의 세 개의 제조 공간을 갖추고 있습니다. 이 사이트는 2023년 ISPE 올해의 시설 상을 수상하였으며, 에너지 관리, 환경 관리 및 산업 안전에 대한 ISO 인증을 보유하고 있습니다.
WuXi Biologics a annoncé des réalisations significatives dans son installation de Dundalk, en Irlande, y compris l'achèvement réussi de plusieurs essais de Qualification de Performance de Processus (PPQ) de 16 000 litres et des approbations GMP par l'HPRA pour les trois installations de fabrication. Le site a réalisé deux essais PPQ avec un taux de réussite de 100 % en utilisant une technologie innovante à usage unique, combinant quatre bioréacteurs de 4 000 litres pour égaler les performances des systèmes traditionnels en acier inoxydable.
L'installation, opérationnelle depuis mars 2022, emploie plus de 760 personnes et dispose de trois suites de fabrication : une suite de perfusion de 6 000 L et une suite en lot de 48 000 L. Le site a reçu le prix ISPE Facility of the Year en 2023 et détient des certifications ISO pour la gestion de l'énergie, la gestion environnementale et la sécurité au travail.
WuXi Biologics gab bedeutende Erfolge in seiner Einrichtung in Dundalk, Irland, bekannt, darunter den erfolgreichen Abschluss mehrerer 16.000-Liter-Prozessleistungsqualifizierungen (PPQ) und GMP-Zulassungen von der HPRA für alle drei Produktionsstätten. Der Standort erreichte zwei PPQ-Durchläufe mit einer Erfolgsquote von 100 % unter Verwendung innovativer Einwegtechnologie, die vier 4.000-Liter-Bioreaktoren kombiniert, um die Leistung traditioneller Edelstahl-Systeme zu erreichen.
Die Einrichtung, die seit März 2022 in Betrieb ist, beschäftigt über 760 Personen und verfügt über drei Fertigungseinheiten: eine 6.000L Perfusionssuite und eine 48.000L Fed-Batch-Suite. Der Standort erhielt 2023 den ISPE Facility of the Year Award und hält ISO-Zertifizierungen für Energiemanagement, Umweltmanagement und Arbeitssicherheit.
- Successful completion of 16,000L PPQ runs with 100% success rate
- GMP approval received from HPRA for all three manufacturing facilities
- Demonstrated cost-effectiveness comparable to traditional 20,000L reactors
- Company has passed ~40 global regulatory inspections with 67 license approvals
- Facility employs over 760 skilled workers
- None.
- Multiple successful 16,000L PPQ runs highlight that disposable manufacturing can achieve similar performance as traditional stainless reactors
- GMP Authorizations by HPRA demonstrate that new global sites have built strong world-class regulatory and quality system
DUNDALK,
These PPQ runs achieved 16,000-liter scale by combining four 4,000-liter single-use bioreactors, representing one of the largest cell culture processes using single-use technology worldwide. The scale-up was not only innovative and more ESG-friendly, but also demonstrated the company's ability to deliver comparable Cost of Goods (COGS) to traditional large-scale stainless-steel bioreactors up to 20,000L.
The GMP authorization was granted by HPRA following a comprehensive on-site inspection in October 2024, which evaluated the GMP oversight of all data, processes, personnel, manufacturing, storage, and analytical areas across the multi-product facility. The granting of this approval provides WuXi Biologics the opportunity to expand its services to support the unmet needs of patients worldwide and highlights the commitment to comply with standards and legislation allowing it to release clinical and commercial biologics drug substances for global clients, benefiting patients worldwide. To date, the company has passed approximately 40 global regulatory inspections and has received 67 license approvals.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "These accomplishments reflect the remarkable speed, agility, and execution capabilities of our
Since becoming operational in March 2022, WuXi Biologics Ireland site that began as greenfield development in Dundalk has rapidly established itself as a leader in advanced biomanufacturing. With over 760 skilled employees, the facility combines cutting-edge design, sustainability, and scalability. Recognized with the prestigious International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Award (FOYA) in 2023, the site features three advanced drug substance manufacturing suites: 6,000L perfusion suite (MFG6.1 and MFG6.2) and a 48,000L fed-batch suite (MFG7).
In addition to its manufacturing capabilities, the site is deeply committed to sustainability, holding ISO certifications in energy management (ISO 50001), environmental management (ISO 14001), and occupational safety (ISO 45001). These achievements demonstrate WuXi Biologics' dedication to advancing the industry through innovation and environmental responsibility.
About WuXi Biologics
WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
With over 12,000 skilled employees in
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com.
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SOURCE WuXi Biologics
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