WuXi Biologics Launches HEK 293 Stable Cell Line Platform WuXia293 Stable for Development and Manufacturing of Difficult-to-Express Molecules
WuXi Biologics (WXXWY) has launched WuXia293Stable, an innovative HEK293 cell line platform designed for developing and manufacturing difficult-to-express molecules. The platform achieves fed-batch titers up to 5.0 g/L for monoclonal antibodies while significantly improving purity.
The new platform demonstrates high titers, human glycosylation, and improved product quality by reducing truncation issues common in complex modalities. WuXia293Stable maintains stable expression during long-term cell passages and offers scalable manufacturing capabilities at 2000L scale for fed-batch and 1000L scale for perfusion.
This addition strengthens WuXi Biologics' WuXia™ platform family, which includes other specialized platforms like WuXiaADCC Plus™ and WuXia RidGS™, enhancing the company's comprehensive biologics development capabilities.
WuXi Biologics (WXXWY) ha lanciato WuXia293Stable, una piattaforma innovativa basata su cellule HEK293 progettata per lo sviluppo e la produzione di molecole difficili da esprimere. La piattaforma raggiunge titoli in fed-batch fino a 5,0 g/L per anticorpi monoclonali, migliorando in modo significativo la purezza.
La nuova piattaforma mostra elevati titoli, glicosilazione di tipo umano e una qualità del prodotto superiore grazie alla riduzione dei problemi di troncamento comuni nelle modalità complesse. WuXia293Stable mantiene un'espressione stabile durante passaggi cellulari prolungati e offre capacità di produzione scalabili a 2000 L in fed-batch e 1000 L in perfusione.
Questa aggiunta rafforza la famiglia di piattaforme WuXia™ di WuXi Biologics, che include altre soluzioni specializzate come WuXiaADCC Plus™ e WuXia RidGS™, potenziando le capacità complessive dell'azienda nello sviluppo di biologici.
WuXi Biologics (WXXWY) ha lanzado WuXia293Stable, una innovadora plataforma de células HEK293 diseñada para desarrollar y fabricar moléculas difíciles de expresar. La plataforma alcanza títulos en fed-batch de hasta 5,0 g/L para anticuerpos monoclonales, mejorando significativamente la pureza.
La nueva plataforma ofrece altos títulos, glicósilación humana y una mayor calidad del producto al reducir los problemas de truncamiento habituales en modalidades complejas. WuXia293Stable mantiene una expresión estable durante pasajes celulares a largo plazo y proporciona capacidades de fabricación escalables a 2000 L en fed-batch y 1000 L en perfusión.
Esta incorporación fortalece la familia de plataformas WuXia™ de WuXi Biologics, que incluye otras plataformas especializadas como WuXiaADCC Plus™ y WuXia RidGS™, ampliando las capacidades integrales de desarrollo de productos biológicos de la compañía.
WuXi Biologics (WXXWY)가 WuXia293Stable을 출시했습니다. 이는 발현이 어려운 분자들의 개발 및 제조를 위해 설계된 혁신적인 HEK293 세포주 플랫폼입니다. 해당 플랫폼은 단클론항체에 대해 fed-batch 타이터 최대 5.0 g/L를 달성하면서 순도를 크게 향상시켰습니다.
새 플랫폼은 높은 타이터, 인간형 당화 및 복잡한 제형에서 흔히 발생하는 절단(truncation) 문제의 감소를 통해 향상된 제품 품질을 보여줍니다. WuXia293Stable은 장기 세포 계대 배양 동안 안정적인 발현을 유지하며 fed-batch 2000L 및 퍼퓨전 1000L 규모로 확장 가능한 제조 역량을 제공합니다.
이번 추가로 WuXi Biologics의 WuXia™ 플랫폼군이 강화되었으며, WuXiaADCC Plus™ 및 WuXia RidGS™와 같은 다른 특화 플랫폼들과 함께 회사의 전반적인 바이오의약품 개발 역량을 향상시킵니다.
WuXi Biologics (WXXWY) a lancé WuXia293Stable, une plateforme innovante de lignées cellulaires HEK293 conçue pour le développement et la fabrication de molécules difficiles à exprimer. La plateforme atteint des titres en fed-batch allant jusqu'à 5,0 g/L pour les anticorps monoclonaux tout en améliorant significativement la pureté.
La nouvelle plateforme offre des titres élevés, une glycosylation humaine et une meilleure qualité de produit en réduisant les problèmes de troncature fréquents dans les modalités complexes. WuXia293Stable maintient une expression stable lors de passages cellulaires à long terme et propose des capacités de fabrication évolutives à 2000 L en fed-batch et 1000 L en perfusion.
Cette addition renforce la famille de plateformes WuXia™ de WuXi Biologics, qui comprend d'autres plateformes spécialisées telles que WuXiaADCC Plus™ et WuXia RidGS™, renforçant les capacités globales de l'entreprise en développement de biologiques.
WuXi Biologics (WXXWY) hat WuXia293Stable eingeführt, eine innovative HEK293-Zelllinienplattform zur Entwicklung und Herstellung von schwer exprimierbaren Molekülen. Die Plattform erzielt Fed-Batch-Titer von bis zu 5,0 g/L für monoklonale Antikörper und verbessert dabei die Reinheit deutlich.
Die neue Plattform zeigt hohe Titer, menschliche Glykosylierung und verbesserte Produktqualität durch Verringerung von Trunkierungsproblemen, die bei komplexen Modalitäten häufig auftreten. WuXia293Stable behält eine stabile Expression über langfristige Zellpassagen bei und bietet skalierbare Herstellungsfähigkeiten auf 2000 L für Fed-Batch und 1000 L für Perfusion.
Diese Ergänzung stärkt die WuXia™-Plattformfamilie von WuXi Biologics, zu der auch spezialisierte Plattformen wie WuXiaADCC Plus™ und WuXia RidGS™ gehören, und erweitert die umfassenden Entwicklungskapazitäten des Unternehmens im Bereich Biologika.
- Achieves high fed-batch titer of up to 5.0 g/L for monoclonal antibodies
- Platform eliminates or significantly reduces truncation issues in complex molecules
- Offers scalable manufacturing capabilities up to 2000L for fed-batch and 1000L for perfusion
- Maintains stable expression and consistent product quality during long-term cell passages
- None.
- WuXia293Stable platform demonstrates high titer, human glycosylation and improved product quality by eliminating or significantly alleviating truncation in difficult-to-express molecules.
- WuXia293Stable platform maintains stable expression and consistent product quality during long-term cell passages, enabling scalable clinical and commercial manufacturing.
Conventionally, CHO cells have been widely utilized for recombinant protein expression with proven track record of high titers, and good developability and manufacturability. However, complex modalities may not be compatible with CHO expression system, resulting in low titer levels and truncation issues, due to the impact of some CHO-specific host cell proteins (HCPs), that compromise the quality and functionality of the protein products. In contrast, HEK293 cells can eliminate or significantly alleviate truncation issues in expressing complex molecules while maintaining high titer levels.
WuXi Biologics developed WuXia293Stable by leveraging its proprietary HEK293 cell line. Derived from WuXi Biologics' highly-vetted mammalian cell line development platform family WuXia™, WuXia293Stable demonstrates productivity, quality and stability comparable to WuXia™ while maintaining full compatibility with its process, as shown by its robust growth and balanced metabolism.
The platform achieves a fed-batch titer of up to 5.0 g/L for monoclonal antibodies while significantly improving purity. WuXia293Stable offers flexible scalability in culture scale to meet the diverse needs of various research and pre-clinical development stages. Furthermore, the WuXia293Stable cell line maintains stable expression and consistent quality during long-term cell passages, enabling scalable clinical and commercial manufacturing at 2000L scale for fed-batch and 1000L scale for perfusion. Moreover, WuXi Biologics offers a comprehensive suite of services for the WuXia293Stable platform, including cell bank testing and viral clearance validation as part of its one-stop CMC solution.
The launch of the WuXia293Stable platform has further strengthened the service capabilities of WuXi Biologics' WuXia™ platform family. Besides WuXia293stable, the WuXia™ platform has already derived multiple cell line development platforms, including WuXiaADCC Plus™ and WuXia RidGS™, to address customers' diverse requirements.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are excited to launch an industry-leading solution that significantly enhances the development of advanced therapeutics. WuXia293Stable stands as a powerful testament to WuXi Biologics' unwavering commitment to our vision that every biologic can be made and exemplifies our dedication to technological innovation, which enables us to adeptly address the evolving needs of the biopharmaceutical industry. Once again we are reaffirming our promise to enable our clients in accelerating the delivery of innovative biologics to patients worldwide. "
About the WuXia™ Cell Line Development Platform Family
WuXia™ is a proven, high-yield (up to about 11 g/L) mammalian cell line platform family developed by WuXi Biologics. Accepted by regulatory agencies worldwide, the WuXia™ platform family have generated over 1000 cell lines expressing monoclonal and bispecific antibodies, fusion proteins, enzymes and other recombinant proteins for clinical and commercial manufacturing as of 2024.
The WuXia™ platform family include WuXiaADCC Plus™ for developing and manufacturing afucosylated antibodies to elicit an enhanced ADCC response, WuXia RidGS™ for non-antibiotic cell line development, and the latest WuXia293Stable for expressing difficult-to-express molecules built on HEK293 cell lines. The WuXia™ cell line development platform family continue to expand to cater to the diverse needs of global customers.
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SOURCE WuXi Biologics
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