• Enables measurements up to 2 days earlier for antibody titers for both clone selection and bioprocess monitoring.¹
• Provides up to 7x improvements in sensitivity with novel high efficiency particles.²
• Delivers 2x more attribute information with simplified multi-attribute workflows.³

Waters Corporation announces the launch of the BioResolve™ Protein A Affinity Columns with MaxPeak™ Premier Technology, providing precise titer measurements. This launch marks the first set of affinity chromatography columns that Waters has brought to market, in a groundbreaking move as the Company continues to release new products that solve unmet needs in large molecule separations. The new columns enable earlier access to results in upstream bioprocessing, faster method optimization in downstream development for biologics, and a new level of agility in the discovery, optimization, and manufacturing of antibody-based drug products.

"Today's launch of the BioResolve Protein A Affinity Columns will help to bring lifesaving therapies to patients, faster. One of the main bottlenecks in the development of biotherapeutics like monoclonal antibodies is the time required to identify and optimize a suitable cell line for antibody production," said Dr. Udit Batra, President and Chief Executive Officer, Waters Corporation. "We have solved for this by designing a novel, highly efficient particle with an immobilized Protein A surface, and combined this with MaxPeak Premier Hardware, resulting in the most sensitive protein A column on the market."  

The BioResolve Protein A Affinity Columns have been designed to provide up to 7x improvements in sensitivity compared to the market leader. The novel, non-porous 3.5 μm particles allow accurate quantitation of antibody titers at lower concentrations and with less sample. In addition, the columns have been designed to couple with size exclusion chromatography columns to measure titer concentrations and aggregate analysis in a single run on any LC system.

"The new column will enhance our ability to support our clients in developing new medicines," said Arnaud Delobel, R&D and Innovation Director, Quality Assistance. "It simplifies two-dimensional workflows for simultaneous titer and aggregate analysis, and can be readily integrated into new LC/MS setups to analyze in-process antibody samples without prior purification. By streamlining workflows and enabling simultaneous assessment of multiple critical quality attributes, it helps cut project turnaround times and ultimately supports faster time to market for biologics."

This innovation furthers the Company's commitment to enhancing the analytical toolbox for biomolecule characterization, allowing scientists to speed up the development of safe, efficacious, and accessible biotherapeutics.

The columns are available in 2.1 x 20 mm and 3.9 x 5 mm formats and are available to order now.

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1. Improved ability to detect antibody at 7x lower concentrations using low-dispersion U(H)PLC allows for titer measurements at least one day earlier based on standard CHO cell line doubling time.
2. Application note 720008775EN: In a well-controlled experiment, the lower limit of quantitation of NISTmAb reference material RM 8671 was 5x-7x lower using the 2.1 x 20 mm and 3.9 x 5 mm BioResolve Protein A Affinity Columns using a low-dispersion UPLC compared to a leading competitor.
3. Application note 720008780EN: Demonstrates the measurement of antibody titer and aggregate analysis in a single run following a direct-connect ProA-SEC method.

About Waters Corporation

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.

Waters, BioResolve, and MaxPeak are trademarks of Waters Technologies Corporation.

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