Waters

The October 2025 FDA draft guidance for biosimilars marks a major shift toward greater reliance on analytical data. Most notably, it signals a move to reduce or even eliminate comparative efficacy studies when robust analytics can provide equivalent insight, detecting subtle differences that clinical studies often miss. Biosimilar development will continue to require comprehensive analytical packages, with emphasis on orthogonal techniques. This session features Colette Quinn from Waters Corporation, who discusses how analytics support biosimilar development and help meet the FDA’s “totality-of-evidence” expectations.

The October 2025 FDA draft guidance for biosimilars marks a major shift toward greater reliance on analytical data. Most notably, it signals a move to reduce or even eliminate comparative efficacy studies when robust analytics can provide equivalent insight, detecting subtle differences that clinical studies often miss. Biosimilar development will continue to require comprehensive analytical packages, with emphasis on orthogonal techniques. This session features Colette Quinn from Waters Corporation, who discusses how analytics support biosimilar development and help meet the FDA’s “totality-of-evidence” expectations.

Improve analysis of betamethasone derivatives with CORTECS™ Premier C8 Columns featuring MaxPeak™ HPS Technology for sharper peaks and better analytical performance.

Improve validated HPLC methods by switching from fully porous to CORTECS™ Premier C18 5 µm Columns to boost throughput, cut solvent use, and enhance method greenness.

Apply the 5 Rules of Scale Up to confidently scale LC purifications from analytical to prep, ensuring consistent, high-purity target recovery with robust results.

Improve prep LC performance and recovery. See how MaxPeak Premier OBD Columns help isolate B vitamins and unknowns by minimizing metal surface interactions.

In this study, the unique capabilities of a LC-UV/MS workflow to accelerate analysis are demonstrated in the identification of impurities related to GLP-1 analogs that underwent chemical and thermal stress conditions.

In this study, we present a QC-friendly LC-UV/MS workflow designed to alleviate the workload on analytical laboratories. Access to orthogonal mass data allows supporting labs to make quicker and more informed decisions during method development, reducing errors, and increasing overall productivity.

Learn about new advancements for achieving increased component resolution, shorter run times and more consistent recoveries of HMWPs with outstanding reproducibility.

This application note examines the USP acetaminophen impurities using an HPLC system and UPLC System. Improvements in sample throughput and solvent usage were realized by using newer technology.

In this application note the USP monograph method for naproxen sodium tablets was modernized and Analytical Method Greenness Scoring (AMGS) values were assigned to each system used. The use of newer technology including sub-2 µm columns provides not only improvements to throughput and solvent usage but also drastically improved AMGS values.

This application note examines the analysis of quetiapine fumarate using HPLC, UHPLC and UPLC Columns. Considerable improvements to run time and solvent usage were achieved by modernizing to UPLC Columns.

We assess the benefits of the Alliance iS Bio HPLC System by migrating and modernizing a compendial SEC method outlined in the USP General Chapter <129>.

Combining the gradient method adjustments with the Alliance™ iS HPLC System to achieve both column dimension and system modernization for the USP monograph separation of abacavir sulfate

Webinar Date/Time: Wed, May 1, 2024 10:00 AM EDT

The use of method development software with analytical quality by design (AQbD) approaches can produce robust methods but are limited by both access to the software and user proficiency. Other approaches require more manual intervention to select the correct conditions, interpret the results, and make decisions based on the data. This application note, we explore using a systematic screening protocol to develop a method for the analysis of a mixture of nine structurally similar spice cannabinoids.

Triazine herbicides are commonly used in crop management to remove invasive plant species. These herbicides disrupt the photosynthesis cycle, leading to plant death and can contaminate soil and groundwater if used in high enough concentrations and for long enough duration. As such, the monitoring of these herbicides is important to minimize and monitor contamination. The app note outlines using a systematic screening protocol to develop a method for the analysis of a mixture of seven structurally similar triazine herbicides.

Often, method development activities are performed “on the fly” with tight timelines to achieve the goal of developing robust methods quickly. Unfortunately, the approach to method development is an often-overlooked aspect of the process. In this app note, we talk about employing a systematic screening protocol, which utilizes a structured decision-making process, alleviates the pressure on the analyst to select the best set of conditions, and streamlines the method development process.

Webinar Date/Time: Tue, Feb 13, 2024 11:00 AM EST

In this work we discuss an automatable sample preparation protocol for peptide mapping used in QC, bioprocess, analytical development, and research environments to deliver comprehensive information about the primary structure of biotherapeutic proteins.

In this work we discuss how to achieve complete and clean trypsin digestion with an enzyme that provides a balance of missed cleavage, non-specific cleavage, and trypsin autolysis.

In this work we discuss an automated high-throughput sample preparation method and fast LC-MS peptide mapping for Critical Quality Attribute (CQA) peptide measurement that was developed for low volume and low concentration microbioreactor samples.

Learn more about how the System Monitoring application provides real-time, contextual details for all Empower™ Software-controlled chromatography systems, helping you easily coordinate your laboratory work and respond dynamically to changing priorities.

The waters_connect™ System Monitoring is the latest innovation in lab management, providing real-time information for all Empower-controlled chromatography systems via the waters_connect cloud platform. Coordinating laboratory work and responding dynamically to changing priorities has never been easier.

Complete and clean trypsin digestion can be achieved with an enzyme that provides a balance of low levels of missed cleavage, non-specific cleavage, and trypsin autolysis. RapiZyme, a next generation trypsin, offers efficiency and reproducibility.

Webinar Date/Time: Thu, May 4, 2023 11:00 AM EDT

Tyrosine Kinase Inhibitors (TKIs) are a class of small molecule drugs used to alter cell growth pathways for the treatment of cancer. Specifically, Sunitinib, a TKI on the market, is available to treat a variety of cancers including pancreatic cancer. Here we create a method to support the therapeutic drug monitoring of Sunitinib and its active metabolite.

Webinar Date/Time: Europe: Thursday, March 30th, 2023 at 2pm BST | 3pm CEST | 9am EDT North America: Thursday, March 30th, 2023 at 1pm EDT | 10am PDT | 6pm BST Asia: Friday, March 31st, 2023 at 12pm JST | 11am CST | 11pm EDT

How standardized, high-performance surface consumables solve the challenge of non-specific adsorption for metal-sensitive analytes in bioseparations.