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The October 2025 FDA draft guidance for biosimilars marks a major shift toward greater reliance on analytical data.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The October 2025 FDA draft guidance for biosimilars marks a major shift toward greater reliance on analytical data.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.

Applying Analytical Quality by Design (AQbD) principles to impurity method development enables robust, science-based strategies for characterizing and controlling critical quality attributes in protein therapeutics. This webinar will present a case study on developing a fluorescence-based (FLR) method for quantifying Mannose-5 glycans, demonstrating how risk-based design and systematic evaluation of method parameters enhance reliability, reproducibility, and product understanding across the biopharmaceutical lifecycle.

Webinar Date/Time: Tue, Sep 16, 2025 11:00 AM EDT

Webinar Date/Time: Tue, Jul 22, 2025 11:00 AM EDT

Webinar Date/Time: Thu, Sep 5, 2024 11:00 AM EDT

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

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

Waters is introducing new SPE sample preparation kits for oligonucleotide bioanalysis that demonstrate improved recovery and reproducibility using a standardized detergent-free protocol that minimizes method development, is automation friendly and works across a diverse range of oligonucleotide therapeutics. The webinar covers the challenges when establishing an oligonucleotide quantitation workflow and how they are addressed using this new SPE kit-based approach.

This app note reviews the development of the OligoWorks SPE Microplate Kit and detergent-free protocol for oligonucleotide bioanalysis and demonstrates performance across a broad range of chemically diverse oligonucleotides, including GalNAc and lipid-conjugated species. The analytical testing and screening work to optimize the protocol for high recovery and low matrix effects is discussed in detail and LC-MS data is presented for spiked plasma and urine samples showing excellent inter and intra-kit, day-to-day and user-to-user reproducibility (RSDs ≤15%).

This app note demonstrates automation of the OligoWorks SPE Microplate Kit and protocol using the Andrew + pipetting robot and presents quantitative LC-MS data across a diverse set of oligonucleotide therapeutics spiked into plasma. Quantitative LC-MS results from the automated detergent-free workflow are compared to results from manual processing demonstrating equivalent performance as well as excellent reproducibility, underscoring the benefits of automating the OligoWorks SPE Microplate Kit: a streamlined sample extraction workflow, reduced errors, reproducible analytical method performance and enhanced lab productivity.

Is software critical to your success with Multiple-Attribute Methods? Hear from experts across the industry in volume 5 of our Expert Discussion Series. Learn about their perspectives on informatics requirements for MAM.

Hear from experts across the industry in volume 1 of our Expert Discussion Series on Multi Attribute Methods. Learn about their perspectives on the opportunities and challenges of implementing MAM in their lab.

How confident are you deploying LC-MS systems for Multi-Attribute Methods in routine labs? Hear from experts across the industry in volume 6 of our Expert Discussion Series on Multi-Attribute Methods. Learn about their perspectives on system requirements for MAM.

Download this eBook for fresh perspectives on the capabilities and adoption of MAM workflows within the biopharmaceutical industry.

How to handle new peak detection with Multi-Attribute Methods? Hear from experts across the industry in volume 3 of our Expert Discussion Series. Learn about their perspectives on the considerations of new peak detection

Download this application notebook illustrating key attribute monitoring workflows developed to improve and streamline MAM analysis of biotherapeutic proteins.

Can you really deploy a Multiple-Attribute Method in a routine lab? Hear from experts across the industry in volume 4 of our Expert Discussion Series.

Hear from experts across the industry in volume 2 of our Expert Discussion Series on Multi Attribute Methods. Learn about their perspectives on MAM sample preparation and automation.

Webinar Date/Time: Wed, Nov 1, 2023 11:00 AM EDT

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 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.

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.

Bioprocessing for protein production is a time-consuming process, typically lasting about two weeks. It is increasingly desirable to routinely monitor critical process and product attributes such as changes in nutrient profiles and high level glycoform information for the drug substance. Read our latest application note to learn how the newly launched bioprocess walk-up solutions enable bioprocess engineers to collect attributes easily and rapidly for process related monitoring and optimization using the Andrew+ Pipetting Robot, Waters OneLab Software and the BioAccord LC-MS System.

Waters bioprocess walk-up solutions unlock access to high quality process and product data with just a few clicks, even for users with little knowledge of mass spectrometry. Providing streamlined integration of automated sample preparation and LC-MS analytics simplifies, accelerates and advances your bioprocess development.

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.

Obtain more data without the ambiguity of traditional chromatographic and electrophoretic assays. This notebook compiles app notes generated by the Biopharmaceutical Scientific Operations Team at Waters. They illustrate key attribute monitoring workflows that have been developed to improve and streamline MAM analysis of biotherapeutic proteins.

Webinar Date/Time: Wed, Dec 14, 2022 11:00 AM EST

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