Pronalyse is a new division of Creative Proteomics, which is an integrated CRO with rich experience in providing drug development services for over 10 years. To assist customers in understanding the changes in protein charge heterogeneity throughout manufacturing and purification, Creative Proteomics Pronalyse offers antibody drug charge variant analysis services using isoelectric focusing or ion exchange chromatography technology platforms.
Antibodies will undergo a lot of modification and degradation during production and storage, such as oxidative deamidation, glycosylation, C-terminal lysine truncation, N-terminal pyroglutamate cyclization, disulfide bond modification, sequence variation, etc. All changes in quantity or structure will lead to the heterogeneity of antibody charge distribution, thereby affecting the biological activity, pharmacokinetics, immunogenicity and structural stability of antibody drugs.
The existence of charge isomers will affect the activity, binding ability, pharmacokinetics, immunogenicity and structural stability of protein drugs, thereby affecting the effectiveness, safety and shelf life of the drug. At the same time, the degree of control of charge heterogeneity also reflects the consistency of the production process of recombinant protein drugs. Therefore, in the research and development of biosimilar drugs and the evaluation of consistency with the original drug, charge heterogeneity is an important factor for process quality control.
Creative Proteomics’s charge heterogeneity analysis technology platform:
(1)Gel Isoelectric Focusing Electrophoresis (IEF): The separation of proteins by isoelectric point (PI) is routinely used for fingerprint analysis of charge isoforms of recombinant proteins.
(2)Capillary isoelectric focusing (CIEF): Separate and detect antibodies based on differences in isoelectric point (pI). The pI value reflects the uniformity of the charge and spatial conformation of the protein drug.
(3)Imaged capillary isoelectric focusing (iCIEF): The resolution of this method is comparable to that of traditional isoelectric focusing gel electrophoresis, and it has the advantage of whole-column imaging.
(4)Ion exchange chromatography: Including cation exchange chromatography and anion exchange chromatography. Ion exchange chromatography can separate proteins with similar isoelectric points.
“Creative Proteomics will strictly abide by the FDA, ICH, USP and EP guidelines, and provide you with comprehensive analysis services for the charge heterogeneity of antibody drugs. We will customize exclusive solutions for you based on your samples, and are confident to provide you with technical support related to special requirements such as drug development and production processes. ” Said Creative Proteomics’s Senior Scientist.
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. More information can be reached at https://www.creative-proteomics.com/pronalyse/charge-heterogeneity-analysis-service.html
