Are you looking to conduct analysis and characterization of your bispecific and multispecific antibodies?
Why characterize bispecific and multispecific antibodies ?
The analysis of bispecific and multispecific antibodies in a laboratory setting presents a complex challenge due to their unique structure and mechanism of action.
Unlike traditional monoclonal antibodies (mAbs), bispecific and multispecific antibodies are designed to recognize and bind to two or more different antigens, providing enhanced therapeutic versatility. Laboratory analysis of these molecules requires advanced methods to assess their structure, stability, binding efficacy, and their ability to induce specific biological responses.
This involves techniques such as mass spectrometry, chromatography, and functional assays to evaluate their biological activity.
Rigorous laboratory characterization is essential to ensure these antibodies meet quality (CQAs), safety, and efficacy criteria, especially in the context of their development for clinical applications.
Our solutions for the analysis and characterization of your bispecific and multispecific antibodies
Why choose FILAB ?
FILAB, an analytical expertise laboratory, offers in-depth expertise in the analysis and characterization of bispecific and multispecific antibodies, in compliance with current guideline, including ICH Q6B. With our expertise, we develop customized analyses tailored to your specific needs at every stage of development, whether in the preclinical phase or research and development.
Our analytical services can be customized to meet your requirements throughout the development and production cycle, with a particular focus on the critical quality attributes (CQAs) of your bispecific and multispecific antibodies.
FILAB offers a comprehensive range of services for the characterization and analysis of these complex molecules.
Our analysis services
Structural analysis and characterization of bispecific and multispecific antibodies
Reduced forms (HC, LC, Fab, FC)
Glycosylation profiling
De novo sequencing
Characterization of physicochemical properties
We provide precise data on the size, mass, and physicochemical properties of your bispecific and multispecific antibodies, essential for their development, validation, and quality control :
Identification and characterization of impurities in biopharmaceutical products
The detection, analysis, and characterization of impurities are crucial to ensuring the safety, efficacy, and regulatory compliance of biosimilars :
For process-related impurities, our laboratory offers specific tests, such as the quantification of elemental impurities according to USP 233 and ICH Q3D, as well as extractables and leachables (E&L) analyses. We also analyze cell culture media (amino acids, vitamins, saccharides) to ensure the quality of biosimilar bioproduction processes.
