Physicochemical and Structural Analyses
Characterizing the inherent structural heterogeneity is an essential requirement of the development of a therapeutic monoclonal antibody. High and low molecular weight species, charge variants and post translational modifications can all affect in vivo stability, loss of biological activity and unwanted immune effects.
Our team of experienced chemists can provide the support and advise required to ensure that these risks are managed by ensuring assessments are performed at appropriate stages of the development of a therapeutic antibody. We offer a comprehensive range of methods to characterize and confirm protein structure, carbohydrate profile, post-translational modifications and impurities utilizing state-of-the-art techniques to ensure the ICH Q6B scientific guidelines are met resulting in an efficient streamlined development process.
We provide solutions to characterize the following physicochemical properties and structural attributes:
|Physicochemical Properties||Structural Characterization and Confirmation|
|Molecular Weight (Intact Mass) and Size (Size exclusion Chromatography)||Carbohydrate Structure (Released N-glycan Analysis)|
|Liquid Chromatographic Pattern (SEC, IEX)||Amino Acid Sequence|
|Isoform Pattern (Ion Exchange Chromatography)||Amino Acid Composition|
|Extinction Coefficient||Terminal Amino Acid Sequence|
|Electrophoretic Pattern||Peptide Map|
|Spectroscopic Profiles||Sulfhydryl groups and Disulphide bridges|
At the heart of the biosimilar development process, lies an understanding of the link between antibody structure and function. BioOutsource offers the capabilities to understand the structural complexities of your biosimilar mAb and how this influences protein-protein interactions and consequently drives the ensuing biological activity.
This side by side analysis can be conducted to provide a comprehensive characterization data package to aid data-driven decisions at critical stages of biosimilar development.
Contact our scientists today to discuss your physicochemical and structural analyses requirements.