Pronalyse is a new division of Creative Proteomics, which is an integrated CRO company with rich experience in providing drug development service for over 10 years. The company has recently announced Protein Drug Modification Analysis service to help researchers determine the modification type, modification site, and modification structure of protein drugs.
Mature protein medicines have complete amino acid sequences, but they generally require a series of post-translational modifications (PTMs) before they can perform certain biological functions. Modification and processing have various forms, including but not limited to glycosylation, phosphorylation, ubiquitination, acetylation, methylation, etc.
Protein modification includes natural modification and artificial modification. For naturally modified protein drugs, it is very important to determine the modification type, modification site and modification structure. For artificially designed protein drugs with 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 affect 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 a consistent PTM is a huge process challenge facing the biopharmaceutical industry. Therefore, it is very important to detect the PTM of biotech drugs between different batches,” said the Senior Scientist of Creative Proteomics.
Creative Proteomics provides the following protein drug modification analysis services, which are all besed on SCIEX Triple Quad™ 7500 LC-MS/MS System or Agilent 6545 LC/Q-TOF.
- 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
“Creative Proteomics will strictly abide by regulations and guidelines, and provide you with a comprehensive protein drug modification analysis solution. We have mature analysis methods and are confident to provide professional technical support for biopharmaceutical companies in the R&D or production process of product consistency analysis, degradation product analysis, shelf life testing, production process improvement, etc.” stated Creative Proteomics’s Product Manager.
About Pronalyse division of Creative Proteomics
Pronalyse is supported by specialists who are professional and skilled in protein chemistry, NMR, HPLC, mass spectrometry and bioinformatics. Currently, Pronalyse is dedicated to providing protein-oriented analysis service to support manufacturers and researchers in biopharmaceutical development, mainly including antibodies, PEGylated proteins, peptide and protein drugs, vaccines, amino acids and their derivatives. The service provided contains in vitro characterization, purity analysis, protein structure modification, in vivo safety check, and pharmacokinetics analysis, etc.