Antibody Drug Modification Analysis

Post-translational modifications are common testing program in the characterization of acid-base peaks of antibody drugs and in product comparability studies. The ICH-Q6B guideline requires that biopharmaceuticals should be analyzed for deamidation, phosphorylation, glycosylation, oxidation, and other forms of modification to develop acceptance quality criteria. Creative Proteomics offers a wide range of tools for characterizing post-translational modification types and content changes that accurately identify and control key attributes affecting the safety, stability and efficacy of antibody drugs to ensure compliance.

Why Characterize Post-Translational Modifications of Antibody Drugs?

Antibody molecules are subject to post-translational modifications during secretion, expression, purification and storage by the intracellular and extracellular environments, and common modifications include oxidation on methionine (Met), deamidation on asparagine (N), cyclization on the N-terminal Q (pyroQ), and loss of lysine at the C-terminal, etc. These modifications cause changes in the local conformation and charge of the antibody, which exhibit different ratios of acid-base peaks on the IEF. Modifications occurring in the CDR affect activity and cause a decrease in the therapeutic effect of the antibody drug. Therefore, a thorough understanding of the various post-translational modifications is important for preclinical and clinical development and commercial supply of antibody drugs.

Introduction of Post-Translational Modification Analysis Services

Antibody-based therapeutics can be modified in a variety of ways during production, purification. Creative Proteomics, through High Performance Liquid Chromatography (HPLC)-High Resolution Mass Spectrometry (HRMS) and advanced analytical software, can accurately characterize the sites and relative quantities of various modifications that occur, including, but not limited to, the following:

• Disulfide Bond Localization
• Oxidation
• Deamidation
• Phosphorylatio
• N-terminal Pyroglutamylation Ratio
• C-Terminal Lys Deletion Analysis
• Glycan Analysis
• Glycation Modification Analysis
• Glycosylation Site Analysis

Technological Processes at Creative Proteomics

Creative Proteomics provides customized one-stop characterization solutions based on your needs, including the entire process of sample processing, mass spectrometry detection, and data analysis. The samples analyzed for post-translational modifications and sequence coverage were enzymatically digested in a similar manner. We calculate the sites and ratios of post-translational modifications based on sequence comparison results to provide accurate modification information.

Advantages of Our Post-Translational Modification Analysis Services

• The professional team is familiar with the key points of the analysis process, avoiding the interference and error brought by manual operation.
• The standardized operation process ensures fast, accurate service and delivery of results.
• High-resolution equipment and advanced data analysis system can dig deep into the post-translation modification information.

What We Deliver?

Creative Proteomics provides our clients with authentic, reliable and timely characterization analysis with our advanced technology platform. Contact us to learn more about our post-translational modification analysis services. We will be happy to assist you.