Waters Launches Alliance iS Bio HPLC System to Help Biopharma QC Labs Increase Efficiency and Reduce Errors
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Insights
The introduction of the Alliance iS Bio HPLC System by Waters Corporation represents a strategic move to solidify its presence in the biopharmaceutical quality control market. This advancement is poised to address critical efficiency and error reduction needs within QC laboratories, which are central to the regulatory compliance and product release processes in the biopharma industry. From a market perspective, the emphasis on reducing human error and boosting productivity through technology aligns with the broader industry trend towards automation and precision in biopharmaceuticals.
By incorporating MaxPeak HPS Technology, the system mitigates risks associated with analyte interaction, which can compromise test results and lead to costly rework. The potential to eliminate up to 40% of common errors not only enhances the reliability of QC outcomes but also translates into direct cost savings for laboratories. This could result in increased adoption rates, thereby expanding Waters Corporation's market share and potentially impacting its financial performance positively.
In the realm of biopharmaceuticals, the quality of QC analysis is paramount due to the potential impact on patient safety and regulatory adherence. The Alliance iS Bio HPLC System's bio-inert design and compatibility with specialized vials and plates directly address the industry's need for more stringent quality measures. This system's ability to enhance resolution and sensitivity while reducing peak tailing is a significant technical improvement that can streamline the drug development pipeline by accelerating the time-to-market for new biologics.
Furthermore, the integration with Empower Chromatography Software is a noteworthy feature that can help QC labs manage data more effectively, a non-trivial benefit given the increasing complexity of data in biopharma. This could lead to improved compliance management and reduce the risk of regulatory setbacks, which are often a major concern for stakeholders in the industry.
From a financial standpoint, the launch of the Alliance iS Bio HPLC System could represent a significant revenue driver for Waters Corporation. The system's advanced features and potential to reduce operational costs for users present a compelling value proposition that may lead to strong sales performance. Given that QC labs are under constant pressure to minimize errors and adhere to stringent regulations, the demand for such innovative solutions is likely to be robust.
Investors should monitor the uptake of this new system closely, as it could lead to upward revisions in revenue forecasts and potentially enhance Waters Corporation's competitive edge in the HPLC market. The company's stock price could react positively to the news of the launch, especially if early adoption rates and customer feedback are favorable. However, it is important to consider the investment required for R&D and marketing of the new system, which could affect short-term profitability.
News Summary:
- New Alliance™ iS Bio High Performance Liquid Chromatography (HPLC) System helps biopharmaceutical QC laboratories boost efficiency and eliminate up to
40% of common errorsi. - Featuring MaxPeak™ High Performance Surface (HPS) Technology, the new system minimizes unwanted analyte interactions to increase resolution and sensitivity while reducing peak tailing for metal-sensitive analytes.
- Next-generation system delivers a new level of simplicity and instrument intelligence to biologics QC analyses, helping laboratories meet quality, compliance, and on-time product delivery goals.
The bio-inert design of the instrument features Waters MaxPeak HPS Technology applied to key internal components including the system flow path to reduce unwanted interactions from metal-adsorbing analytes. The system pairs with Waters QuanRecovery™ Vials and Plates, as well as MaxPeak Premier HPLC Columns with eConnect™ Column Tag Technology, allowing for more confident platform methods that eliminate the need for lengthy column conditioning and method development.
"Many of the challenges that impact productivity and revenues for QC labs come from human error. We collaboratively developed the Alliance iS Bio HPLC System with our customers to address daily routine challenges and help meet more stringent and evolving compliance requirements while working to achieve shorter product release timelines," said Fraser McLeod, Vice President, General Manager, QA/QC, Waters Corporation. "We built every feature of this powerful HPLC platform, including the use of bio-inert surface technology at key sample touchpoints, with simplicity, sophistication and efficiency in mind, to help biopharma QC labs save time and money."
The Alliance iS Bio HPLC System also combines with Waters compliance-ready Empower Chromatography Software to help laboratories collect, manage, and report chromatography test results. It integrates seamlessly with Waters and third-party liquid chromatography instruments to help high-volume QC labs manage operational risk, mitigate disruptions, and increase overall productivity.
The Alliance iS Bio HPLC System is now available globally.
Additional Resources
- Learn more about the Alliance iS Bio HPLC System on Waters.com
- View the Waters Analytica 2024 Online Press Kit
- View the Alliance iS Bio online launch webcast
- Waters App Note: "Deploying the Alliance iS Bio HPLC System as a Modern HPLC for Biopharmaceutical Analysis in QC Environments"
- Waters App Note: "Modernizing Compendial SEC Methods for Biotherapeutics Using the Alliance iS Bio HPLC System"
- Follow and connect with Waters via LinkedIn, Twitter, and Facebook
About Waters Corporation (www.waters.com)
(NYSE:WAT), a global leader in analytical instruments and software, has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, food, and environmental sciences for more than 65 years. With approximately 7,900 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.
Waters, MaxPeak, Alliance, QuanRecovery and eConnect are trademarks of Waters Technologies Corporation.
Contact:
Kevin Kempskie
Senior Director of Public Relations
Waters Corporation
kevin_kempskie@waters.com
+1.617.413.4333
i Estimate based on Waters market research in 2022 after surveying 56 global pharmaceutical company QC labs.
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SOURCE Waters Corporation
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