WuXi Biologics Launches Next-Generation Platform WuXiHigh鈩�2.0 for High-Concentration Biologics with Protein Concentration Reaching 230 mg/mL
WuXi Biologics (WXXWY) has launched WuXiHigh鈩�2.0, an advanced formulation development platform for high-concentration biologics. The platform achieves protein concentrations up to 230 mg/mL, surpassing the current FDA-approved maximum of 200 mg/mL, while reducing viscosity by up to 90%.
The technology leverages proprietary excipient blends and integrates high-throughput instruments to predict viscosity and aggregation risks. It supports ultrafiltration/diafiltration operations at viscosities up to 100 cP and precision filling at up to 50 cP. The platform addresses the growing demand for high-concentration biologics, which currently represent over 20% of FDA-approved monoclonal antibody products.
WuXi Biologics (WXXWY) ha lanciato WuXiHigh鈩�2.0, una piattaforma avanzata per lo sviluppo di formulazioni ad alta concentrazione di biologici. Questa piattaforma raggiunge concentrazioni proteiche fino a 230 mg/mL, superando il massimo attualmente approvato dalla FDA di 200 mg/mL, riducendo al contempo la viscosit脿 fino al 90%.
La tecnologia sfrutta miscele proprietarie di eccipienti e integra strumenti ad alta produttivit脿 per prevedere i rischi di viscosit脿 e aggregazione. Supporta operazioni di ultrafiltrazione/diafiltrazione a viscosit脿 fino a 100 cP e il riempimento di precisione fino a 50 cP. La piattaforma risponde alla crescente domanda di biologici ad alta concentrazione, che attualmente rappresentano oltre il 20% dei prodotti a base di anticorpi monoclonali approvati dalla FDA.
WuXi Biologics (WXXWY) ha lanzado WuXiHigh鈩�2.0, una plataforma avanzada para el desarrollo de formulaciones de productos biol贸gicos de alta concentraci贸n. La plataforma alcanza concentraciones de prote铆nas de hasta 230 mg/mL, superando el m谩ximo aprobado actualmente por la FDA de 200 mg/mL, mientras reduce la viscosidad hasta en un 90%.
La tecnolog铆a utiliza mezclas exclusivas de excipientes e integra instrumentos de alto rendimiento para predecir riesgos de viscosidad y agregaci贸n. Soporta operaciones de ultrafiltraci贸n/diafiltraci贸n con viscosidades de hasta 100 cP y llenado de precisi贸n hasta 50 cP. La plataforma responde a la creciente demanda de productos biol贸gicos de alta concentraci贸n, que actualmente representan m谩s del 20% de los productos de anticuerpos monoclonales aprobados por la FDA.
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WuXi Biologics (WXXWY) a lanc茅 WuXiHigh鈩�2.0, une plateforme avanc茅e de d茅veloppement de formulations pour des biologiques 脿 haute concentration. Cette plateforme atteint des concentrations prot茅iques allant jusqu'脿 230 mg/mL, d茅passant ainsi le maximum actuellement approuv茅 par la FDA de 200 mg/mL, tout en r茅duisant la viscosit茅 jusqu'脿 90%.
La technologie utilise des m茅langes exclusifs d鈥檈xcipients et int猫gre des instruments 脿 haut d茅bit pour pr茅dire les risques de viscosit茅 et d鈥檃gr茅gation. Elle prend en charge les op茅rations d鈥檜ltrafiltration/diafiltration 脿 des viscosit茅s allant jusqu鈥櫭� 100 cP et le remplissage de pr茅cision jusqu鈥櫭� 50 cP. Cette plateforme r茅pond 脿 la demande croissante de biologiques 脿 haute concentration, qui repr茅sentent actuellement plus de 20% des produits d鈥檃nticorps monoclonaux approuv茅s par la FDA.
WuXi Biologics (WXXWY) hat WuXiHigh鈩�2.0 eingef眉hrt, eine fortschrittliche Plattform zur Entwicklung von Formulierungen f眉r hochkonzentrierte Biologika. Die Plattform erreicht Proteinkonzentrationen von bis zu 230 mg/mL und 眉bertrifft damit das derzeit von der FDA zugelassene Maximum von 200 mg/mL, w盲hrend die Viskosit盲t um bis zu 90% reduziert wird.
Die Technologie nutzt propriet盲re Hilfsstoffmischungen und integriert Hochdurchsatz-Instrumente zur Vorhersage von Viskosit盲ts- und Aggregationsrisiken. Sie unterst眉tzt Ultrafiltrations-/Diafiltrationsprozesse bei Viskosit盲ten bis zu 100 cP und pr盲zises Abf眉llen bis zu 50 cP. Die Plattform reagiert auf die steigende Nachfrage nach hochkonzentrierten Biologika, die derzeit 眉ber 20% der von der FDA zugelassenen monoklonalen Antik枚rperprodukte ausmachen.
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- High viscosity and aggregation challenges in high-concentration formulations can increase immunogenicity risks
- Complex manufacturing process requiring specialized conditions for ultrafiltration/diafiltration operations
- The WuXiHigh鈩�2.0 technology platform harnesses proprietary excipient blends and expertise to enable concentrations up to 230 mg/mL
- It reduces viscosity by up to
90% while maintaining formulation stability and injectability
High-concentration biologics, typically defined as formulations exceeding 100 mg/mL protein, offer advantages including reduced injection volume, improved dosing efficiency and enhanced patient adherence. They have increasingly emerged as a critical R&D priority for pharmaceutical companies. Currently, over
The highest formulation concentration documented in FDA-approved biologics is 200 mg/mL. The WuXiHigh鈩�2.0 technology platform enables concentration levels of up to 230 mg/mL by leveraging the company's proprietary excipient blends and expertise. The significantly enhanced concentration translates to greater flexibility in injection volume, reduced dosing frequency, and simplified cold-chain logistics, while boosting drug substance manufacturing and drug product manufacturing efficiency. By deploying over 24 proprietary excipient combinations, the platform substantially reduces viscosity by up to
Additionally, WuXiHigh鈩�2.0 integrates high-throughput instruments to predict viscosity and aggregation risks. This rapid, data-driven approach enables smarter excipient selection from the earliest formulation stages, accelerating development timelines and minimizing material consumption. The platform supports ultrafiltration/diafiltration (UF/DF) operations at viscosities up to 100 cP and precision filling at up to 50 cP, ensuring seamless technology transfer and scale-up鈥攆rom early clinical development to commercial manufacturing.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "WuXiHigh鈩�2.0 represents a transformative technology platform for next-generation biologics with high-concentration formulations. Its ability to enhance concentration while reducing viscosity redefines industry benchmarks, and more importantly elevates patient experience without compromising drug efficacy. We remain committed to integrating innovative science with deep expertise in drug product formulation, enabling our clients to efficiently accelerate development and deliver therapies 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 鈥� from concept to commercialization 鈥� 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:听.
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