Waters Introduces BioResolve Protein A Affinity Columns to Accelerate Antibody Titer Measurement, Enhancing Process Agility and Batch Quality
- Up to 7x improvement in sensitivity compared to market leaders
- Enables measurements up to 2 days earlier for antibody titers
- Delivers 2x more attribute information with simplified workflows
- Can analyze samples without prior purification, reducing processing time
- First entry into affinity chromatography columns market, expanding product portfolio
- None.
Insights
Waters' new Protein A columns significantly improve antibody analysis speed and sensitivity, strengthening their position in the growing biologics market.
Waters Corporation has launched BioResolve Protein A Affinity Columns with MaxPeak Premier Technology, representing their first entry into the affinity chromatography column market. This strategic product expansion directly addresses critical bottlenecks in biotherapeutic development.
The technical specifications are impressive: the columns enable antibody titer measurements up to 2 days earlier than current methods, provide up to 7x improvement in sensitivity compared to market leaders, and deliver 2x more attribute information through simplified multi-attribute workflows. The technology uses novel non-porous 3.5 μm particles that allow accurate quantitation at lower concentrations with reduced sample volumes.
This innovation is particularly significant for the rapidly growing monoclonal antibody market. By accelerating cell line identification and optimization, Waters is addressing a major pain point in biologics development. The columns' ability to couple with size exclusion chromatography for simultaneous titer concentration and aggregate analysis in a single run represents meaningful workflow efficiency.
The testimonial from Quality Assistance's R&D Director highlights the product's practical benefits in streamlining two-dimensional workflows and enabling LC/MS integration without prior sample purification. This validation from an industry partner suggests genuine utility rather than merely incremental improvement.
Waters is strategically positioning this product within their broader biologics analysis portfolio, reinforcing their commitment to the high-value biotherapeutics market. This launch strengthens Waters' competitive position against other analytical instrument providers in the lucrative and growing biologics segment, potentially capturing additional market share in bioprocessing workflows.
News Summary
- 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
"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.
Additional Resources: See application notes and specifications at www.Waters.com/affinity
ABOUT: 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.
Contact:
Molly Gluck
Head of External Communications
Waters Corporation
Molly_gluck@waters.com
Mobile: +1.617.833.8166
- 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.
- 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. - Application note 720008780EN: Demonstrates the measurement of antibody titer and aggregate analysis in a single run following a direct-connect ProA-SEC method.
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SOURCE Waters Corporation