N-Terminal Sequencing Analysis

N-terminal sequencing analysis finds frequent application as a simple biologics identity test, complements mass spectrometry for confirmation of impurity sequence, and enables simple confirmation of leucine/isoleucine identity, which is challenging by mass spectrometry. Multiple subunits, such as reduced monoclonal antibodies, can also be sequenced after prior separation by SDS-PAGE. For release testing, Charles River can validate N-terminal sequencing methodology as an identity test.

  • Automated Edman Degradation
  • De novo Sequencing
  • Pyroglu deblocking of N-Terminus
  • GMP Drug Substance ID Testing
  • Truncation / Multiple N-Termini Determination
  • SDS PAGE + PVDF Sample Prep for Multiple-Subunit Sequencing

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Amino Acid Analysis & Extinction Coefficient Determination

Charles River also provides amino acid analysis and extinction coefficient determination for client products. We have performed these studies on a wide range of biological molecules, including peptides, complex and PEGylated biologics, molecules containing unusual amino acids, monoclonal antibodies, vaccines, gene therapy vectors, and heavily glycosylated glycoproteins.

  • Extinction Coefficient Determination
  • Mole Percent Amino Acid Analysis
  • Timed Hydrolysis Studies
  • Gamma Carboxyglutamic Acid (GLA)
  • Tryptophan Determination
  • Lysine Quantification for Polylysine Formulations
  • Collagen Hydroxyproline and Hydroxylysine Ratio Determinations

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