Biopharmaceutical Variation Analysis Services
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Service Details
Changes in the post-translational modification state of proteins affect the stability, efficacy, pharmacokinetics, and drug safety of biopharmaceutical molecules. Oxidation, deamidation, and mutation are the most important modification problems encountered by biopharmaceuticals. Oxidation can occur on a variety of amino acid residues, and the most prone to oxidative modification is methionine (Met), which is oxidized to generate methionine sulfoxide. Deamidation is a post-modification that often occurs during the production and storage of monoclonal antibody drugs. It usually occurs on the side chain of asparagine (Asn, N), and a small part of this modification also exists on glutamine. Mutation is a primary sequence change that may occur during the production of monoclonal antibody drugs. If the mutation occurs in the CDR region, it will affect the antibody-antigen recognition. Currently, mass spectrometry is the only tool that can accurately characterize the type and content of post-translational modifications. With rich experience and capabilities in Mass Spectrometry, Creative Proteomics provides comprehensive biopharmaceutical variation analysis services to accelerate your biopharmaceutical development.
As a global protein sequencing and mass spectrometry service provider, Creative Proteomics has been providing comprehensive analytical support for biopharmaceuticals. Our laboratory is equipped with high-performance liquid chromatography-high-resolution mass spectrometry technology to accurately identify the sites and relative amounts of various modifications. Through bottom-up proteome analysis technology, the main post-translational modification types of biopharmaceuticals can be characterized, the Deepnovo technology built into PEAKS software is based on feature and de novo technology, which can analyze the post-translational modification and site mutation of monoclonal antibody with high sensitivity.
Based on high-resolution mass spectrometry technology, Creative Proteomics provides a series of complete biopharmaceutical variation analysis solutions services for global researchers, including but not limited to:
Biopharmaceutical Disulfide Bond Analysis Service
Biopharmaceutical Glycan Analysis Service
Biopharmaceutical Glycosylation Site Analysis Service
Antibody C-Terminal Variation Analysis Service
Antibody N-Terminal Cyclization Analysis Service
Antibody Deamidation and Isomerization Analysis Service
Creative Proteomics provides comprehensive and systematic biopharmaceutical qualification services to meet regulatory requirements for global biopharmaceutical characterization. With our advanced analytical platforms and professional bioscientists, we can provide our customers with a series of biopharmaceutical variation analysis services, whether you are developing biosimilars, novel molecules, peptides, antibodies, bispecifics/Multispecificity, drug conjugates or any other molecule! In addition, our expert team can also provide the most economical and professional customized solutions according to your requirements. If you are interested in our services, or have any questions, please contact us without any hesitation.
For research use only, not intended for any clinical use.