Waters Expands Alliance iS Bio HPLC Product Line with Photodiode Array Detector to Enhance Spectral Insights for Biopharma Development & QC
Waters (NYSE:WAT) has expanded its Alliance™ iS Bio HPLC product line with integrated photodiode array (PDA) detection, enhancing capabilities for biopharmaceutical development and Quality Control laboratories. The system delivers significant improvements including:
- Up to 80x boost in sensitivity with MaxPeak™ Premier columns
- Over 3x improvement in day-to-day reproducibility
- Reduction in carryover by up to two orders of magnitude
- 40% reduction in common user errors
The platform is designed to simplify laboratory workflows and reduce out-of-specification results. All configurations are controlled by Waters Empower™ Chromatography Data System and support LIMS connectivity. The system has earned ACT Ecolabels from My Green Lab for sustainable manufacturing practices.
Waters (NYSE:WAT) ha ampliato la sua linea di prodotti Alliance™ iS Bio HPLC con rilevamento integrato a matrice di fotodiodi (PDA), migliorando le capacità per lo sviluppo biopharmaceutico e i laboratori di Controllo Qualità. Il sistema offre miglioramenti significativi, tra cui:
- Aumento della sensibilità fino a 80 volte con le colonne MaxPeak™ Premier
- Miglioramento di oltre 3 volte nella riproducibilità quotidiana
- Riduzione del carryover fino a due ordini di grandezza
- Riduzione del 40% degli errori comuni degli utenti
La piattaforma è progettata per semplificare i flussi di lavoro di laboratorio e ridurre i risultati fuori specifica. Tutte le configurazioni sono controllate dal sistema di dati cromatografici Waters Empower™ e supportano la connettività LIMS. Il sistema ha ottenuto le etichette ecologiche ACT da My Green Lab per pratiche di produzione sostenibili.
Waters (NYSE:WAT) ha ampliado su línea de productos Alliance™ iS Bio HPLC con detección integrada de matriz de fotodiodos (PDA), mejorando las capacidades para el desarrollo biofarmacéutico y laboratorios de Control de Calidad. El sistema ofrece mejoras significativas, incluyendo:
- Aumento de hasta 80 veces en sensibilidad con columnas MaxPeak™ Premier
- Mejora de más de 3 veces en la reproducibilidad diaria
- Reducción del carryover hasta en dos órdenes de magnitud
- Reducción del 40% en errores comunes de los usuarios
La plataforma está diseñada para simplificar los flujos de trabajo de laboratorio y reducir los resultados fuera de especificación. Todas las configuraciones son controladas por el sistema de datos cromatográficos Waters Empower™ y soportan conectividad LIMS. El sistema ha recibido etiquetas ecológicas ACT de My Green Lab por prácticas de fabricación sostenibles.
Waters (NYSE:WAT)는 포토다이오드 배열(PDA) 검출이 통합된 Alliance™ iS Bio HPLC 제품 라인을 확장하여 생물 제약 개발 및 품질 관리 실험실의 기능을 향상시켰습니다. 이 시스템은 다음과 같은 중요한 개선 사항을 제공합니다:
- MaxPeak™ Premier 컬럼을 사용하여 감도를 최대 80배 향상
- 일일 재현성에서 3배 이상의 개선
- Carryover를 최대 두 자릿수 감소
- 일반 사용자 오류를 40% 감소
이 플랫폼은 실험실 작업 흐름을 간소화하고 비규격 결과를 줄이도록 설계되었습니다. 모든 구성은 Waters Empower™ 크로마토그래피 데이터 시스템에 의해 제어되며 LIMS 연결을 지원합니다. 이 시스템은 지속 가능한 제조 관행에 대해 My Green Lab로부터 ACT 에코 레이블을 받았습니다.
Waters (NYSE:WAT) a élargi sa gamme de produits Alliance™ iS Bio HPLC avec une détection intégrée par réseau de photodiodes (PDA), améliorant ainsi les capacités pour le développement biopharmaceutique et les laboratoires de Contrôle Qualité. Le système offre des améliorations significatives, notamment :
- Jusqu'à 80 fois d'augmentation de la sensibilité avec les colonnes MaxPeak™ Premier
- Amélioration de plus de 3 fois de la reproductibilité quotidienne
- Réduction du carryover jusqu'à deux ordres de grandeur
- Réduction de 40 % des erreurs courantes des utilisateurs
La plateforme est conçue pour simplifier les flux de travail en laboratoire et réduire les résultats hors spécifications. Toutes les configurations sont contrôlées par le système de données chromatographiques Waters Empower™ et prennent en charge la connectivité LIMS. Le système a reçu des étiquettes écologiques ACT de My Green Lab pour des pratiques de fabrication durables.
Waters (NYSE:WAT) hat seine Produktlinie Alliance™ iS Bio HPLC mit integrierter Photodiodenarray (PDA)-Detektion erweitert und die Möglichkeiten für die biopharmazeutische Entwicklung und Qualitätskontrolllabore verbessert. Das System bietet bedeutende Verbesserungen, darunter:
- Bis zu 80-fache Steigerung der Empfindlichkeit mit MaxPeak™ Premier-Säulen
- Über 3-fache Verbesserung der täglichen Reproduzierbarkeit
- Reduzierung des Carryovers um bis zu zwei Größenordnungen
- 40% Reduzierung der häufigen Benutzerfehler
Die Plattform wurde entwickelt, um die Laborabläufe zu vereinfachen und Ergebnisse außerhalb der Spezifikation zu reduzieren. Alle Konfigurationen werden durch das Waters Empower™ Chromatographie-Datenmanagementsystem gesteuert und unterstützen die LIMS-Konnektivität. Das System hat von My Green Lab ACT-Umweltzeichen für nachhaltige Herstellungspraktiken erhalten.
- Up to 80x sensitivity improvement with MaxPeak Premier columns
- 3x better day-to-day reproducibility in analysis
- Significant reduction in carryover (two orders of magnitude)
- 40% reduction in common user errors
- Enhanced laboratory workflow efficiency through LIMS integration
- None.
Insights
Waters' expansion of the Alliance iS Bio HPLC product line with PDA detection represents a significant technological advancement for biopharmaceutical testing workflows. The 80x sensitivity improvement when paired with MaxPeak Premier columns directly addresses a critical pain point in detecting low-concentration impurities during drug development and QC processes.
The threefold enhancement in day-to-day reproducibility and carryover reduction by two orders of magnitude tackles fundamental challenges in regulated environments where consistency and precision are paramount. These improvements translate to tangible operational benefits: fewer failed runs, reduced investigation time, and higher throughput.
What's particularly valuable is the platform's error-reduction capabilities, potentially decreasing common user mistakes by 40%. In regulated pharmaceutical environments, this directly impacts compliance outcomes and operational efficiency by minimizing costly out-of-specification investigations.
Waters has strategically positioned this release to strengthen its foothold in the high-value biopharma QC market. The integration with Empower Chromatography Data System and LIMS connectivity creates an ecosystem approach that increases switching costs for customers, reinforcing Waters' competitive positioning against rivals like Agilent and Thermo Fisher.
The immediate availability suggests manufacturing readiness and completed validation, indicating minimal execution risk for this product enhancement.
This Alliance iS Bio HPLC enhancement addresses critical bottlenecks in biopharmaceutical quality workflows. The addition of photodiode array detection enables multidimensional analytical capabilities essential for comprehensive characterization of complex biologics - particularly for peak purity assessment, impurity identification, and method validation.
The reduction in carryover by up to two orders of magnitude is especially valuable for biologics testing where sample-to-sample contamination can compromise data integrity. For facilities handling multiple products or high-potency compounds, this feature alone justifies technology refreshes.
Waters' emphasis on out-of-the-box performance optimization tackles a persistent industry challenge: the lengthy method development and system optimization cycles that delay drug development timelines. By delivering preconfigured systems that minimize the need for specialized expertise, Waters is addressing the industry-wide talent shortage in analytical chemistry.
The ACT Ecolabel certification aligns with the biopharma industry's increasing focus on sustainability metrics in vendor selection processes and supports ESG initiatives that now influence capital equipment decisions. This represents thoughtful positioning beyond technical specifications.
For Waters investors, this expansion reinforces the company's strong position in biopharmaceutical testing - one of the highest-growth segments within analytical instrumentation due to the continued expansion of biologics pipelines and increasing regulatory scrutiny of product quality attributes.
News Summary
- Boosts out-of-the-box sensitivity by up to 80 times with MaxPeakTM Premier columns.1
- Delivers over threefold improvements in day-to-day reproducibility2 and decreases carryover by up to two orders of magnitude.3
- Reduces common user errors by up to
40% .4
"The addition of the Alliance iS Bio HPLC System with PDA detection allows biopharmaceutical laboratories to perform enhanced spectral analysis, including impurity detection, peak purity analysis, multi-wavelength detection, and method validation, to deliver safe and effective products," said Fraser McLeod, Vice President, General Manager, QA/QC, at Waters Corporation. "Built on the Alliance iS HPLC Platform, the system is designed to simplify the analysis of complex biopharmaceuticals in development and QC, reduce errors, and improve accuracy and operational efficiency."
The Alliance iS HPLC Platform has been purposefully designed to simplify laboratory workflows by reducing the risk of out-of-specification results and the need for troubleshooting. Default system parameters provide over threefold improvement in day-to-day reproducibility2 and reduce carryover by up to two orders of magnitude,3 compared to other systems on the market. Additionally, with MaxPeak Premier columns, the Alliance iS Bio HPLC System enhances out-of-the-box sensitivity by up to 80 times compared to traditional systems and columns.1
Waters now offers four configurations of the Alliance iS HPLC Platform to support routine quantitative analysis and expanded spectral analysis of small and large molecules in development and QC. All configurations are controlled by the compliance-ready Waters EmpowerTM Chromatography Data System, which enables laboratories to collect, manage, and report chromatography test results. The platform also supports connectivity with laboratory information management systems (LIMS) to help high-volume QC labs manage operational risk, mitigate disruptions, and increase overall productivity.
The Alliance iS HPLC Platform has earned the Accountability, Consistency, and Transparency (ACT) Ecolabels from My Green Lab, a nonprofit organization dedicated to building a global culture of sustainability in science. Notably, the product line was recognized for its sustainable manufacturing practices and innovative error-reducing design, underscoring the commitment of Waters to reducing the most significant environmental impacts.
The Waters Alliance iS Bio HPLC System with PDA detection is available for order now.
Additional Resources:
- See detailed specifications and configurations: Waters Alliance iS Bio HPLC System
- Watch the Alliance iS Bio HPLC System Video
- Watch the Webinar Replay
- Follow and connect with Waters LinkedIn, Twitter, and Facebook
Waters, Alliance, MaxPeak, and Empower are trademarks of Waters Technologies Corporation. |
About Waters Corporation (www.waters.com)
Waters Corporation (NYSE:WAT) is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years. Our Company helps ensure the efficacy of medicines, the safety of food and the purity of water, and the quality and sustainability of products used every day. In over 100 countries, our 7,600+ passionate employees collaborate with customers in laboratories, manufacturing sites, and hospitals to accelerate the benefits of pioneering science.
Contact:
Janice Foley
Senior Public Relations Manager, Corporate Communications
Waters Corporation
janice_foley@waters.com
Mobile: +1.617.823.5555
1. Application Note: Mitigation of Non-Specific Adsorption During Column Conditioning for an Oligonucleotide HILIC Analysis | Waters. In a well-controlled experiment, oligonucleotides were analyzed with a HILIC application to compare method performance with stainless steel systems and columns with MaxPeak HPS solutions. Percent recovery was tracked for all possible configurations without system passivation and the system configuration with a MaxPeak HPS column and Alliance iS Bio System outperformed other configurations with 80x greater sensitivity than an all-stainless-steel configurations (Figure 10). | |
2. Application Note: HPLC Autosampler Performance II: Improved Injection Precision of USP Methods With the Alliance™ iS HPLC System. In multiple well-controlled experiments with a range of analytes and diluents, injection precision was highest on the Alliance iS HPLC system compared to other HPLC systems on the market. | |
3. Application Note: Improved chlorhexidine carryover performance using the Alliance iS HPLC System. In a well-controlled experiment, chlorhexidine carryover was measured to be | |
4. Based on Waters market research in 2022, surveying 56 global Pharma QC labs running >25 systems. | |
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SOURCE Waters Corporation
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