molecular mass analysis of antibodies
Mass analysis of recombinant proteins is a key characterization method used to evaluate the entire amino acid sequence of the molecule. It also allows determination of the presence of posttranslational modifications (PTM). Intact mass analysis supports the characterization package for regulatory filings as part of the protein drug development process and may be used to evaluate lot-to-lot consistency on the whole molecule level.
Antibody analysis using mass spectrometry has been used to determine:
- C-terminal lysine processing
- N-terminal heterogeneity
- N-linked carbohydrate profile
- Detect modifcations such as oxidation, succinimide formation, glycation, internal cleavable and thioether formation
Bio-Synthesis offers comprehensive antibody/protein analyses for biopharmaceutical analytical
technologies. The following individual analyses, or a full antibody characterization package, tailored
to the FDA and ICH guidelines and used under GLP/GMP guidelines, may include:
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- Amino Acid sequence analysis
- Amino acid composition analysis
- N- and C- terminal sequencing
- Peptide MS mapping analysis
- Disulfide bridge analysis
- Carbohydrate structure analysis
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- Determining of intact molecular weight
- Electrophoretic and isoform pattern analysis
- Liquid chromatographic patterns
- Identification of posttranslational modifications
- Spectroscopic profiling
- Identification of product related impurities
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