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  6. Multifaceted evaluation to ensure the quality and safety of antibody pharmaceuticals.

Multifaceted evaluation to ensure the quality and safety of antibody pharmaceuticals.

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last updated:Oct 29, 2025

日本ウォーターズ(米国本社 Waters Corporation) 
日本ウォーターズ(米国本社 Waters Corporation) 
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High-precision measurement of size variants, aggregates, and stability using light scattering detectors and LC-MS.

In the development of antibody drugs and antibody-drug conjugates (ADCs, etc.), it is essential to maximize the efficiency of the development process while ensuring the quality and safety of the products. By using light scattering detectors to evaluate size variants, aggregates, stability, and other factors from the early stages of development, it is possible to identify the characteristics of potential candidate antibodies early on and avoid risks and dropouts in the later stages of development. Combining this with LC-MS allows for even more comprehensive characterization. By clicking "Submit," you are deemed to have agreed to Waters' use and processing of the information provided on this site in accordance with Waters' Terms of Use and Privacy Notice. Terms of Use and Privacy Notice www.waters.com/legalandprivacy

    Light Scattering PhotometerMass SpectrometerHigh Performance Liquid Chromatograph
抗体.jpg

Multifaceted evaluation to ensure the quality and safety of antibody pharmaceuticals.

抗体.jpg
抗体.jpg
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Related Products - Multi-Angle Light Scattering (MALS) Detector DAWN Series - Dynamic and Static Light Scattering Measurement Device DynaPro NanoStar 2 - Light Scattering/Zeta Potential Measurement Device DynaPro ZetaStar - Light Scattering Measurement Device DynaPro Plate Reader 3 - Mass Spectrometer BioAccord LC-MS System - Mass Spectrometer Xevo G3 QTof - Low-Adsorption UPLC System ACQUITY Premier

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Applications/Examples of results

Quality assessment by SEC-MALS: - Evaluation of size distribution - Analysis of absolute molecular weight, size, and three-dimensional structure - Characterization of aggregates and fragmentation - Detection of low-concentration aggregates in LBA reagents - Measurement of DAR value of ADC Quality assessment by DLS: - Particle size analysis and colloidal stability evaluation - Preparation method screening - Stability monitoring and assessment of aggregation tendency Characterization and quality assessment by LC-MS: - Structural analysis of proteins - primary structure (amino acid sequence), post-translational modifications (glycosylation, oxidation, deamidation, etc.) - Impurity analysis - aggregates, fragments, variants, etc. - Variant analysis - Multi-attribute Method (MAM) - Molecular weight Please feel free to contact us if you have any requests for application notes, demo analyses, etc.

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BioAccord System with ACQUITY Premier for Routine Analysis of Biopharmaceuticals

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Company information

日本ウォーターズ(米国本社

日本ウォーターズ(米国本社 Waters Corporation) 

Testing, Analysis and Measurement

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Waters Corporation, headquartered in Milford, Massachusetts, USA, has played a pioneering role as a specialized manufacturer of liquid chromatography since its establishment in 1958. Actively engaged in the development of new products and technologies, it has grown into an international group company that supplies not only high-performance liquid chromatography but also mass spectrometers (MS) and thermal analysis instruments. Waters Japan started operations in 1973 (Showa 48) as the Japanese base of Waters Corporation. Inheriting the corporate ethos of the U.S. headquarters, we have made "Customer Success" our mission and continue to provide innovative technologies and lab solutions.

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  • Pharmaceutical and food related
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