Three WuXi Biologics Manufacturing Facilities Receive GMP Certification from Türkiye İlaç ve Tıbbi Cihaz Kurumu (TITCK)
WuXi Biologics (2269.HK) has achieved a significant milestone as three of its manufacturing facilities in Wuxi – MFG1, MFG2, and DP5 – received GMP certification from Turkey's regulatory authority TITCK. This marks the company's first GMP inspection and certification from TITCK, following a comprehensive five-day onsite inspection of two monoclonal antibody biologics.
The company has demonstrated strong regulatory compliance with 44 successful regulatory inspections, including 22 from FDA and EMA, and maintains a 100% pass rate for FDA Pre-License Inspections. WuXi Biologics operates 16 GMP-certified facilities globally and has passed over 1,700 GMP quality audits by global clients, including more than 200 EU Qualified Person audits.
WuXi Biologics (2269.HK) ha raggiunto un traguardo importante: tre dei suoi impianti di produzione a Wuxi — MFG1, MFG2 e DP5 — hanno ottenuto la certificazione GMP dall’autorità regolatoria turca TITCK. Si tratta della prima ispezione e certificazione GMP da TITCK, dopo un’ispezione onsite di cinque giorni su due biologi monoclonali. L’azienda ha dimostrato una forte conformità normativa con 44 ispezioni regolatorie riuscite, tra cui 22 della FDA e dell’EMA, mantenendo un tasso di superamento del 100% per le ispezioni Pre‑License della FDA. WuXi Biologics gestisce 16 stabilimenti GMP certificati a livello globale e ha superato oltre 1.700 audit GMP di qualità da parte di clienti globali, inclusi più di 200 audit EU Qualified Person.
WuXi Biologics (2269.HK) ha logrado un hito significativo: tres de sus instalaciones de fabricación en Wuxi — MFG1, MFG2 y DP5 — obtuvieron la certificación GMP por parte de la autoridad reguladora turca TITCK. Esta es la primera inspección y certificación GMP realizada por TITCK, tras una revisión in situ de cinco días en dos biológicos de anticuerpo monoclonal. La empresa ha mostrado un fuerte cumplimiento normativo con 44 inspecciones regulatorias exitosas, incluyendo 22 de la FDA y la EMA, y mantiene una tasa de aprobación del 100% para las inspecciones de la FDA Pre‑License. WuXi Biologics opera 16 instalaciones GMP certificadas a nivel mundial y ha superado más de 1.700 auditorías de calidad GMP por parte de clientes globales, incluyendo más de 200 auditorías de EU Qualified Person.
WuXi Biologics (2269.HK)가 중요한 이정표를 달성했습니다. 우시에 있는 세 곳의 제조 시설 — MFG1, MFG2, DP5 — 이 터키 규제당국 TITCK로부터 GMP 인증을 받았습니다. 이는 TITCK의 첫 GMP 검사 및 인증으로, 단일 모노클로날 항체 생물학적 제제 두 종에 대한 5일 간의 현장 검사를 거친 뒤 이루어졌습니다. 이 회사는 44건의 성공적인 규제 검사를 포함해 강력한 규제 준수를 입증했으며, FDA 사전면허 검사에서 전 면제 합격률 100%를 유지하고 있습니다. WuXi Biologics는 전 세계에 16개의 GMP 인증 시설을 운영하고 있으며, 글로벌 고객의 GMP 품질 감사 1,700건 이상을 통과했고, 그 중 200건이 EU Qualified Person 감사에 해당합니다.
WuXi Biologics (2269.HK) a franchi une étape majeure: trois de ses installations de fabrication à Wuxi — MFG1, MFG2 et DP5 — ont obtenu la certification GMP de l’autorité turque TITCK. Il s’agit de la première inspection et certification GMP réalisée par TITCK, suite à une inspection sur site de cinq jours concernant deux biologiques monoclonaux. L’entreprise a démontré une solide conformité réglementaire avec 44 inspections réglementaires réussies, dont 22 de la FDA et de l’EMA, et maintient un taux de réussite de 100% pour les inspections FDA Pre-License. WuXi Biologics exploite 16 installations GMP certifiées dans le monde et a passé plus de 1 700 audits qualité GMP par des clients mondiaux, dont plus de 200 audits EU Qualified Person.
WuXi Biologics (2269.HK) hat einen bedeutendenMeilenstein erreicht: Drei seiner Produktionsanlagen in Wuxi — MFG1, MFG2 und DP5 — erhielten die GMP-Zertifizierung von der türkischen Regulierungsbehörde TITCK. Es handelt sich um die erste GMP‑Inspektion und -Zertifizierung durch TITCK nach einer fünftägigen Vor-Ort‑Inspektion von zwei monoklonalen Antikörper-Biologika. Das Unternehmen hat eine starke regulatorische Konformität mit 44 erfolgreichen regulatorischen Inspektionen gezeigt, darunter 22 von FDA und EMA, und verzeichnet eine 100%-ige Erfolgsquote bei FDA Pre‑License‑Inspektionen. WuXi Biologics betreibt weltweit 16 GMP-zertifizierte Einrichtungen und hat über 1.700 GMP‑Qualitätsaudits von globalen Kunden bestanden, darunter mehr als 200 EU Qualified Person Audits.
WuXi Biologics (2269.HK) حققت خطوة مهمة، حيث حصلت ثلاث مرافق تصنيع لها في ووشي — MFG1 و MFG2 و DP5 — على شهادة GMP من سلطة TITCK التنظيمية التركية. هذه هي أول تفتيش وشهادة GMP من TITCK، عقب تفتيش موقعي دام خمسة أيام على نموذجين من الأجسام المضادّة أحادية النسيلة. أظهرت الشركة امتثالاً تنظيمياً قوياً مع 44 تفتيشاً تنظيمياً ناجحاً، بما في ذلك 22 من FDA و EMA، وتحافظ على معدل نجاح 100% في تفتيشات FDA Pre‑License. تدير WuXi Biologics 16 منشأة GMP معتمدة على مستوى العالم، وقد اجتازت أكثر من 1,700 تدقيق لجودة GMP من قِبل عملاء عالميين، بما في ذلك أكثر من 200 تفتيش EU Qualified Person.
WuXi Biologics (2269.HK) 实现了一个重要里程碑：其位于无锡的三家制造基地——MFG1、MFG2 和 DP5——获得土耳其监管机构 TITCK 的 GMP 认证。这是 TITCK 的首次 GMP 检查与认证，此前对两种单克隆抗体生物制剂进行了为期五天的现场检查。公司在监管合规方面表现出色，累计经历了 44 次成功的监管检查，其中包括 FDA 和 EMA 的 22 次，并保持 FDA Pre‑License 检查的 100% 合格率。WuXi Biologics 在全球运营着 16 个 GMP 认证设施，并通过了全球客户的超过 1,700 次 GMP 质量审计，其中包括超过 200 次 EU Qualified Person 审计。
- First successful GMP certification from Turkey's TITCK, expanding market access
- Perfect track record with 100% pass rate for FDA Pre-License Inspections
- Impressive regulatory compliance with 44 successful inspections, including 22 from FDA and EMA
- Strong quality assurance demonstrated by passing over 1,700 GMP client audits
- None.
During the five-day onsite inspection of two monoclonal antibody biologics produced by WuXi Biologics for its clients, the three manufacturing facilities successfully passed TITCK's comprehensive assessment, validating the company's capabilities in providing high-quality services for global clients. All of these facilities have previously received approval from other major regulatory authorities for the development of multiple biologic therapeutics.
WuXi Biologics has consistently demonstrated a proven track record of adherence to the industry's most rigorous quality standards. As of the end of June 2025, it has successfully passed 44 regulatory inspections, including 22 conducted by the FDA and the EMA. The company also holds an industry-leading achievement with a
Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are delighted to receive GMP certification from
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
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SOURCE WuXi Biologics
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