WuXi Biologics' Four Manufacturing Facilities and Biosafety Testing Center Certified Again by European Medicines Agency for Ten Biologics
WuXi Biologics (WXXWY) announced that four of its manufacturing facilities and its Suzhou Biosafety Testing Center in China have received Good Manufacturing Practice (GMP) certificates from the European Medicines Agency (EMA). This certification covers commercial and NDA-ready manufacturing and services for eight biologics. The Suzhou center was certified for services related to ten novel therapies.
The company has a strong track record in quality compliance, having passed 35 global regulatory agency inspections, over 1,250 GMP quality audits by global clients, and more than 145 audits by EU Qualified Persons since 2017. WuXi Biologics currently has 15 GMP-certified drug substance and drug product facilities in its global network.
WuXi Biologics (WXXWY) ha annunciato che quattro dei suoi impianti di produzione e il suo Centro di Test di Biosicurezza di Suzhou in Cina hanno ricevuto certificati di Buona Pratica di Fabbricazione (GMP) dall'Agenzia Europea per i Medicinali (EMA). Questa certificazione copre la produzione commerciale e pronta per la NDA e servizi per otto biologici. Il centro di Suzhou è stato certificato per i servizi relativi a dieci terapie innovative.
L'azienda ha una solida esperienza in materia di conformità alla qualità, avendo superato 35 ispezioni da parte di agenzie regolatorie globali, oltre 1.250 audit di qualità GMP da clienti globali e più di 145 audit da parte di Persone Qualificate dell'UE dal 2017. WuXi Biologics attualmente dispone di 15 impianti di sostanze farmaceutiche e prodotti farmaceutici certificati GMP nella sua rete globale.
WuXi Biologics (WXXWY) anunció que cuatro de sus instalaciones de fabricación y su Centro de Pruebas de Bios Seguridad en Suzhou, China, han recibido certificados de Buenas Prácticas de Fabricación (GMP) de la Agencia Europea de Medicamentos (EMA). Esta certificación abarca la producción comercial y lista para NDA y servicios para ocho productos biológicos. El centro de Suzhou fue certificado para servicios relacionados con diez terapias novedosas.
La empresa tiene un sólido historial en cumplimiento de calidad, habiendo pasado 35 inspecciones de agencias reguladoras globales, más de 1,250 auditorías de calidad GMP por parte de clientes globales, y más de 145 auditorías por parte de Personas Cualificadas de la UE desde 2017. WuXi Biologics actualmente cuenta con 15 instalaciones de sustancias y productos farmacéuticos certificadas GMP en su red global.
우시 생물학(WXXWY)은 중국 수저우에 위치한 네 개의 제조 시설과 생물안전 테스트 센터가 유럽 의약청(EMA)으로부터 우수 제조 관리 기준(GMP) 인증을 받았다고 발표했습니다. 이 인증은 상업적 및 NDA 준비 제조와 여덟 가지 생물학적 제품에 대한 서비스를 포함합니다. 수저우 센터는 열 개의 새로운 치료법과 관련된 서비스에 대한 인증을 받았습니다.
회사는 품질 준수에서 강력한 실적을 보유하고 있으며, 2017년 이후로 35개의 글로벌 규제 기관의 검사, 1,250건 이상의 GMP 품질 감사, 145건 이상의 EU 인증자 감사를 통과했습니다. 현재 우시 생물학은 광범위한 네트워크 내에 15개의 GMP 인증 의약물 및 제품 시설을 보유하고 있습니다.
WuXi Biologics (WXXWY) a annoncé que quatre de ses installations de fabrication et son Centre de Test de Biosécurité de Suzhou en Chine ont reçu des certificats de Bonnes Pratiques de Fabrication (BPF) de l'Agence Européenne des Médicaments (EMA). Cette certification couvre la fabrication commerciale et prête pour la NDA ainsi que des services pour huit biologiques. Le centre de Suzhou a été certifié pour des services liés à dix thérapies novatrices.
L'entreprise a un solide parcours en matière de conformité à la qualité, ayant passé 35 inspections par des agences réglementaires mondiales, plus de 1.250 audits de qualité BPF par des clients mondiaux, et plus de 145 audits par des personnes qualifiées de l'UE depuis 2017. WuXi Biologics possède actuellement 15 installations certifiées GMP pour substances actives et produits pharmaceutiques dans son réseau mondial.
WuXi Biologics (WXXWY) gab bekannt, dass vier seiner Produktionsstätten und das Suzhou-Biosicherheits-Testzentrum in China GMP-Zertifikate (Good Manufacturing Practice) von der Europäischen Arzneimittel-Agentur (EMA) erhalten haben. Diese Zertifizierung umfasst die kommerzielle und NDA-bereite Produktion sowie Dienstleistungen für acht Biologika. Das Zentrum in Suzhou wurde für Dienstleistungen im Zusammenhang mit zehn neuartigen Therapien zertifiziert.
Das Unternehmen hat eine starke Erfolgsbilanz in der Qualitätskonformität, da es seit 2017 35 Inspektionen durch globale Regulierungsbehörden, über 1.250 GMP-Qualitätsaudits von globalen Kunden und mehr als 145 Audits durch EU-qualifizierte Personen bestanden hat. WuXi Biologics verfügt derzeit über 15 GMP-zertifizierte Wirkstoff- und Arzneimittelfabriken in seinem globalen Netzwerk.
- Received EMA GMP certificates for four manufacturing facilities and Suzhou Biosafety Testing Center
- Certified for commercial and NDA-ready manufacturing of eight biologics
- Suzhou center certified for services related to ten novel therapies
- Passed 35 global regulatory agency inspections since 2017
- Completed over 1,250 GMP quality audits by global clients
- Passed more than 145 audits by EU Qualified Persons
- Has 15 GMP-certified drug substance and drug product facilities globally
- None.
Following comprehensive inspections of the company's facilities– specifically MFG1, MFG2, MFG5, and DP1 in Wuxi– EMA GMP certificates were issued for commercial and New Drug Application (NDA)-ready manufacturing and services for eight biologics, an endorsement to the company's capabilities in providing such services for global clients. All of these facilities were previously approved by the EMA and other major regulatory authorities for the development of multiple biologic therapeutics. Furthermore, the company's Suzhou Biosafety Testing Center was once again certified by the EMA to provide services for ten novel therapies, including the eight biologics being manufactured in
WuXi Biologics has a proven track record of strict quality compliance. Since 2017, the company has completed and passed 35 global regulatory agency inspections, more than 1,250 GMP quality audits by global clients, and more than 145 audits by EU Qualified Persons. Currently, WuXi Biologics has 15 GMP-certified drug substance and drug product facilities in its global network.
Dr. Chris Chen, CEO of WuXi Biologics, commented: "We are proud that our facilities have once again been certified by the EMA, reflecting our unwavering commitment to the highest quality standards across the company. Quality audits are crucial to ensuring the safety and efficacy of the global pharmaceutical industry, and WuXi Biologics remains dedicated to enabling our clients in bringing high-quality biologics to patients worldwide."
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 be 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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