Mature protein drugs have complete amino acid sequences, and often require a series of post-translational modifications (PTMs) before they have specific biological activities. Modification and processing have various forms, including but not limited to glycosylation, phosphorylation, ubiquitination, acetylation, methylation, etc. Protein modification includes both natural modification and artificial modification.
For protein drugs with natural modifications, it is very important to determine the modification type, modification site, and modification structure. For protein drugs that are artificially designed to produce specific biological activities and curative effects (such as engineered antibodies, antibody-drug conjugates, antibody-based fusion proteins, etc.), it is necessary to conduct careful analysis and testing of factors such as modification or processing efficiency, modification specificity and accuracy, and stability after modification to verify whether it meets the expected design goals.
Protein PTMs affects many aspects of protein drugs, including their stability, in vivo clearance, immunogenicity, antibody-dependent cytotoxicity, complement-dependent cytotoxicity, etc., thereby affecting the clinical efficacy of the drug.
The consistency of PTM is a key factor to ensure the effectiveness and safety of biotechnology drug treatments, and obtaining consistent PTM is a huge process challenge for the biopharmaceutical industry. Therefore, it is very important to detect PTM of biotechnology drugs between different batches. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) clearly stipulate that biotechnology drugs must be fully analyzed and characterized. Pharmaceutical research materials submitted to regulatory agencies should also include the amino acid sequence, disulfide bond, PTM and other information that reflects the physical and chemical properties of the drug as much as possible.
Creative Proteomics has rich experience in a professional platform and can provide you with post-translational modification analysis services for protein drugs.
Protein Drug Modification Analysis Service We Can Provide:
- Glycosylation analysis
- Phosphorylation analysis
- Deamidation and oxidation analysis
- Disulfide bridges and free sulfhydryl groups analysis
- C-terminal lysine variant determination
- Acetylation analysis
- Determination of N-terminal pyroglutamate ratio
- SCIEX Triple Quad™ 7500 LC-MS/MS System
- Agilent 6545 LC/Q-TOF
Creative Proteomics will strictly abide by the regulations and guidelines to provide you with a comprehensive analysis solution for protein drug modification. We have mature analysis methods and are confident to provide professional technical support for the analysis of product consistency, degradation product analysis, shelf-life testing, and improvement of production processes during the R&D or production process of biopharmaceutical companies. Look forward to working with you. If you have other questions, please feel free to contact us.