Guide to Contract Testing and Characterization of Antibody Drugs
Shimadzu Techno-Research is a company of the Shimadzu Group that conducts specialist contract testing work. It undertakes characterization and standards analysis of biopharmaceuticals and polymeric drugs, particularly antibody drugs,under contract.
Shimadzu Techno-Research offers contract analysis for characterization, which is essential for new drug development and applications.
*1: According to the method of Kuyama, Shima,et al (Proteomics 2008, 8, 1539-1550),C-terminal peptide fragments are isolated after enzyme digestion, and the C-terminal amino acid sequence estimated using a mass spectrometer. Based on the precondition that the predicted amino acid sequence is disclosed.
Analysis is not possible if lysine is the C-terminal amino acid.
*2: LC analysis of peptide fragments after enzyme digestion of protein. Analysis can be conducted using a protein sequencer.
*3: The S-S bonds are predicted from the comparison of the mass spectra of reduced peptide fragments and non-reduced peptide fragments.
Conditional on confirmation of S-S bonds in the antibody constant domains only or on prediction of the amino acid sequence and number and positions of S-S bonds in the variable domains.
Shimadzu Techno-Research handles the contract standards testing of antibody drugs.
Shimadzu Techno-Research offers drug contract testing facilities. It offers an approved GMP facility for drug safety testing and GLP facilities for drug concentration measurements in biosamples. These facilities have been inspected by the FDA and the Japanese Pharmaceuticals and Medical Device Agency, and the quality assurance system is highly regarded by major pharmaceutical manufacturers in Japan and overseas.
In the future, Shimadzu Techno-Research will continue to implement highly reliable systems that meet the pharmaceutical manufacturers' highest quality standards for characterization and standards analysis of biopharmaceuticals and polymeric drugs, particularly antibody drugs.