WuXi Biologics Completes First Commercial PPQ Campaign at 15,000L Production Line in Hangzhou Site
WuXi Biologics (2269.HK) has successfully completed its first commercial Process Performance Qualification (PPQ) campaign at its MFG20 facility in Hangzhou, featuring Asia's first three 5,000L single-use bioreactors (SUBs). The company achieved significant breakthroughs in manufacturing efficiency:
- Reduced protein production costs by nearly 70%
- Increased protein yield by 20% per batch through advanced mass transfer technology
- Expanded total site capacity from 8,000L to 23,000L by integrating with existing 2,000L production lines
The facility demonstrates operational excellence with a 100% PPQ success rate and holds ISO 14001 and ISO 45001 certifications. The company has implemented single-use technology (SUT) manufacturing in over 300 batches across multiple facilities, achieving a 99% production success rate over the past three years.
WuXi Biologics (2269.HK) ha completato con successo la sua prima campagna commerciale di Process Performance Qualification (PPQ) presso la struttura MFG20 di Hangzhou, che ospita i primi tre bioreattori monouso (SUB) da 5.000L in Asia. L'azienda ha raggiunto importanti progressi nell'efficienza produttiva:
- Riduzione dei costi di produzione delle proteine di quasi il 70%
- Incremento del rendimento proteico del 20% per lotto grazie a una tecnologia avanzata di trasferimento di massa
- Espansione della capacità totale del sito da 8.000L a 23.000L integrando le linee produttive esistenti da 2.000L
La struttura dimostra un'eccellenza operativa con un tasso di successo PPQ del 100% e possiede le certificazioni ISO 14001 e ISO 45001. L'azienda ha implementato la tecnologia monouso (SUT) in oltre 300 lotti in diverse strutture, raggiungendo un tasso di successo produttivo del 99% negli ultimi tre anni.
WuXi Biologics (2269.HK) ha completado con éxito su primera campaña comercial de Calificación de Rendimiento de Proceso (PPQ) en su instalación MFG20 en Hangzhou, que cuenta con los primeros tres biorreactores desechables (SUB) de 5,000L en Asia. La compañía logró avances significativos en la eficiencia de fabricación:
- Reducción de los costos de producción de proteínas en casi un 70%
- Aumento del rendimiento de proteínas en un 20% por lote gracias a tecnología avanzada de transferencia de masa
- Expansión de la capacidad total del sitio de 8,000L a 23,000L integrando las líneas de producción existentes de 2,000L
La instalación demuestra excelencia operativa con una tasa de éxito PPQ del 100% y cuenta con certificaciones ISO 14001 e ISO 45001. La compañía ha implementado la tecnología de un solo uso (SUT) en más de 300 lotes en múltiples instalaciones, logrando una tasa de éxito en producción del 99% en los últimos tres años.
WuXi Biologics (2269.HK)는 항저우에 위치한 MFG20 시설에서 아시아 최초의 5,000L 일회용 바이오리액터(SUB) 3대를 갖춘 첫 상업용 공정 성능 검증(PPQ) 캠페인을 성공적으로 완료했습니다. 회사는 제조 효율성에서 중요한 돌파구를 이루었습니다:
- 단백질 생산 비용을 거의 70% 절감
- 고급 질량 전달 기술을 통해 배치당 단백질 수율 20% 증가
- 기존 2,000L 생산 라인과 통합하여 전체 사이트 용량을 8,000L에서 23,000L로 확대
이 시설은 100% PPQ 성공률로 운영 우수성을 입증했으며 ISO 14001 및 ISO 45001 인증을 보유하고 있습니다. 회사는 지난 3년간 여러 시설에서 300회 이상의 배치에 단회용 기술(SUT)을 적용하여 99%의 생산 성공률을 달성했습니다.
WuXi Biologics (2269.HK) a réussi sa première campagne commerciale de qualification de performance de processus (PPQ) dans son site MFG20 à Hangzhou, équipé des trois premiers bioréacteurs à usage unique (SUB) de 5 000 L en Asie. L'entreprise a réalisé des avancées significatives en efficacité de fabrication :
- Réduction des coûts de production de protéines de près de 70 %
- Augmentation du rendement protéique de 20 % par lot grâce à une technologie avancée de transfert de masse
- Extension de la capacité totale du site de 8 000 L à 23 000 L en intégrant les lignes de production existantes de 2 000 L
Le site démontre une excellence opérationnelle avec un taux de réussite PPQ de 100 % et détient les certifications ISO 14001 et ISO 45001. L'entreprise a mis en œuvre la technologie à usage unique (SUT) dans plus de 300 lots sur plusieurs sites, atteignant un taux de réussite de production de 99 % au cours des trois dernières années.
WuXi Biologics (2269.HK) hat seine erste kommerzielle Process Performance Qualification (PPQ)-Kampagne in seiner MFG20-Anlage in Hangzhou erfolgreich abgeschlossen, die Asiens erste drei 5.000L Einweg-Bioreaktoren (SUBs) umfasst. Das Unternehmen erzielte bedeutende Fortschritte in der Produktionseffizienz:
- Reduzierung der Proteinproduktionskosten um nahezu 70%
- Steigerung der Proteinausbeute pro Charge um 20% durch fortschrittliche Massentransfertechnologie
- Erweiterung der Gesamtkapazität des Standorts von 8.000L auf 23.000L durch Integration bestehender 2.000L Produktionslinien
Die Anlage demonstriert operative Exzellenz mit einer 100%igen PPQ-Erfolgsquote und ist nach ISO 14001 und ISO 45001 zertifiziert. Das Unternehmen hat die Einwegtechnologie (SUT) in über 300 Chargen an mehreren Standorten implementiert und in den letzten drei Jahren eine Produktions-Erfolgsquote von 99% erreicht.
- 70% reduction in protein production costs
- 20% increase in protein yield per batch
- Significant capacity expansion from 8,000L to 23,000L
- 99% production success rate over past three years
- 100% PPQ success rate at MFG20 facility
- None.
- The campaign marks the successful commercial-scale PPQ completion of
- Proprietary process innovation reduces protein cost by nearly
- As the company's largest operational single-use bioreactor to date, the system triples total site capacity to 23,000L, enabling flexible scale-up solutions
WuXi Biologics' innovative process technologies have been instrumental in achieving remarkable PPQ outcomes: Protein production costs per gram were reduced by nearly
Dr. Chris Chen, CEO of WuXi Biologics, commented, "The successful completion of the first commercial PPQ campaign of the 15,000-liter single-use bioreactors demonstrates our continued leadership in commercial biomanufacturing. Over the past six years, by leveraging continuous process innovation, the company has applied SUT manufacturing in over 300 batches of scaled production ranging from 4,000L to 16,000L across multiple facilities, achieving a
The MFG20 facility's operational excellence is underscored by its
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 regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com.
View original content:https://www.prnewswire.com/news-releases/wuxi-biologics-completes-first-commercial-ppq-campaign-at-15-000l-production-line-in-hangzhou-site-302432298.html
SOURCE WuXi Biologics
FAQ
What efficiency improvements did WuXi Biologics (WXXWY) achieve with its new 15,000L bioreactor system?
How much did the Hangzhou facility's production capacity increase after adding the new bioreactors?
What is the success rate of WuXi Biologics' single-use technology manufacturing?
What certifications does WuXi Biologics' MFG20 facility hold?
