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Biopharmaceutical
Protein characterization, Impurity analysis for quality assurance
Shimadzu supports widely the analysis of biopharmaceuticals such as antibodies, cytokines, peptides and nucleic acids for manufacturing to meet the guidelines. For their characterization and impurity analysis, there should be a different attention and care in comparison with those of traditional chemical compounds. Our unique tools and unprecedented systems ensure the QA/QC of biopharmaceuticals with reproducible and reliable data in these new fields.
Protein Sequence Analysis
N-terminal amino acid sequence analysis of protein drugs is very important for quality assurance of a biological drug.MS-based N-terminal analysis with ORFinder-NB mass sequencing kit with AXIMA Series MALDI-TOFMS, it is an easy, sensitive and rapid way to confirm the terminal amino acid sequence.
Also our traditional and unique gas-phase protein sequencer PPSQ-31A/33A (based on the Edman chemistry) delivers certain sequence information with very high confidence.
Protein / peptide modification Analysis
Many of the approved protein and peptide biological drugs are glycosylated. The characterization and profiling of these modifications is very important for QA of the biological drugs.
AXIMA Resonance is a suitable tool for the protein / peptide modification analysis.
RNA Analysis
RNA is a key molecule as nucleic acid drug candidate in biopharmaceutical research. The structural and functional analysis of RNA, especially of non-coding RNA, is very important.
AXIMA Resonance is a suitable tool for the structure analysis of small RNA molecules. This mass-based comprehensive approach is referred to as ribonucleome analysis.
Biopharmaceutical Cleaning Validation
Biopharmaceutical Cleaning validation is a procedure for the determination of contaminations or residuals in a reactor after it has been cleaned.
For organic residuals, TOC is the analytical method of choice, as the organic carbon content is considered to be representative of the level of residual biopharmaceutical contamination.
