Monoclonal antibody (mAb)-based therapeutics are playing an increasingly important role in the treatment of various diseases, including cancers, autoimmune diseases, and infectious diseases. During the development phases of mAbs, the critical quality attributes (CQAs), such as physiochemical characteristics, immunological properties, biological activity, as well as purity and impurity, are required to be defined and profiled in details. Here, Creative Biolabs introduces our antibody structure characterization and analysis services, covering antibody sequencing, amino acid composition analysis, carbohydrate content analysis, high-order structure analysis, etc, to our global clients.
mAbs are heterodimers of separate light and heavy chains comprising over 1200 amino acid residues. The structure of mAbs is far more complex than small molecule drugs, including the primary structure, higher order structure, charge variants, and glycosylation variants, etc. Changes to mAb structure introduced during the manufacturing process or storage may influence the therapeutic efficacy, bioavailability, bio-clearance, and immunogenic properties, and thus alter drug safety. As a result, an in-depth characterization of mAb structure is fundamental to therapeutic antibody development and quality control. Creative Biolabs offers a comprehensive characterization of mAb primary structure, high-order structure, PTMs, glycosylation, and chemical modifications to help the evaluation of drug efficacy, stability, and safety, as well as understanding the structure-function relationships.
Creative Biolabs offers antibody molecular weight analysis, which is part of the ICH Q6B guidelines for physicochemical analysis of mAb products, using our mass spectrometry (MS)-based techniques. More specifically, we offer intact mass analysis that provides information on sequence integrity and PTMs, and subunit mass analysis using reduced or enzymatically digested samples.
Creative Biolabs has developed the proprietary Database-Assisted Shotgun Sequencing (DASS) technology, which is based on our next generation antibody sequencing platform, to offer a series of unique de novo antibody sequencing services to global clients. Our services consist of the variable region, variable plus leader region, as well as full-length heavy- and light-chain antibody sequencing for all species, isotypes, and allotypes.
Creative Biolabs has introduced several emerging commercial platforms for epitope binning, including ForteBio Octet platform, ProteOn platform, Biacore system, and IBIS MX96 & CFM, to handle binning of large numbers of antibodies simultaneously in an automated mode by redesigning the concept of a flow channel and the way in which samples are applied and/or delivered.
N- and C-terminal sequences are important structures and functional parts of antibodies. Creative Biolabs combines Edman degradation, De Novo sequencing, and mass spectrometry-based methods (MALDI-TOF) to characterize the N- and C-terminal heterogeneity of mAbs.
Determining amino acid composition following hydrolysis is listed in ICH Q6B as a way to characterize the protein and to confirm its identity by comparing with amino acid composition deduced from the gene sequence of the desired product. Creative Biolabs offers amino acid composition analysis service based on methods including amino acid derivative technology and high-efficiency liquid chromatography.
Analysis of high order structure (HOS) is a key component in defining mAb’s CQAs that forms a critical part of the ICH Q6B guideline and part of the comparability studies. Creative Biolabs provides HOS analysis as part of our antibody structural analysis services using a suite of orthogonal techniques.
Creative Biolabs also provides high-quality carbohydrate structure analysis and peptide mapping services to promote global customers’ projects. If you are interested in our service, please do not hesitate to contact us for more details.
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