Advanced biotherapeutic characterization technologies from Waters help laboratories achieve the standards of regulatory bodies around the world: To produce sufficient analytical and biological evidence of similarity between innovator and biosimilar candidates that will reduce the clinical trial burden for approval. Because whether it's called a biosimilar, follow-on biologic, biogeneric, second-generation mAb, non-innovator protein, or even biobetter, the goal is the same: therapeutic safety and efficacy to improve patient health and wellness.
Watch Catalin Doneanu, Principal Chemist at Waters Corporation, present "Comparison of Host Cell Protein Profiles between an Innovator and a Biosimilar Monoclonal Antibody." Originally presented at BEBPA 2016. |
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Watch Jing Fang, Senior Scientist at Waters Corporation, present "Contribution of HDX-MS to Evaluate the Conformational Similarity of Biosimilars to Reference Products." Originally presented at PAMS 2015. |
Share our video on how LC-MS technologies can help biosimilar developers thoroughly understand the structure and variation of the innovator product to set specifications for their biosimilar. |
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Hear Dr. Wei Xu, Senior Scientist at Regeneron Pharmaceuticals, and Dr. Henry Shion, Principal Scientist at Waters Corporation, discuss the application of MS analysis in areas such as clone selection, optimization of fermentation conditions, and development of purification and formulation. |
View the poster presented at WCBP 2016, titled, "A Streamlined Analytical Platform for Glycan Comparability Assessment for Innovator and Biosimilar Infliximab." |
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View the poster presented at WCBP 2016, titled, "Innovator and Biosimilar Infliximab: Comparability Assessment of the Host Cell Proteins and Protein Higher Order Structure." |
Read the app note, "Combining RapiFluor-MS and UNIFI Scientific Information System for a Total N-linked Glycan Solution for Innovator vs. Biosimilar Infliximab Comparisons." Features the Biopharmaceutical Platform Solution with UNIFI and Xevo G2-XS QTof MS. |
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Read the app note, "Structural Comparison of Infliximab and a Biosimilar via Subunit Analysis Using the Waters Biopharmaceutical Platform with UNIFI." Features intact protein analysis, the ACQUITY UPLC H-Class Bio and Xevo G2-S QTof MS. |
Read the scientific article, "In-depth structural characterization of Kadcyla® (ado-trastuzumab emtansine) and its biosimilar candidate." Published in mAbs journal. |
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Read the scientific article, "Advanced assessment of the physicochemical characteristics of Remicade® and Inflectra® by sensitive LC/MS techniques." Published in mAbs journal. |
In order to establish the biosimilarity of a therapeutic drug candidate to the original innovator molecule, multiple batches of both proteins must be characterized. Waters technologies provide the tools to perform a variety of physicochemical analyses both rapidly and robustly. The seamless integration of column chemistries, instrumentation, and informatics provides a complete platform for performing your critical analyses. Find out how we utilized the Biopharmaceutical Platform Solution with UNIFI to perform characterization of infliximab and a candidate biosimilar.
Structural analysis of a biosimilar and its reference product includes:
In order to confirm theoretical molecular mass and detect sequence errors or PTMs, an intact mass analysis is often performed first.