Peptide level analysis of proteins by LC-MS is one of the primary approaches for the characterization of biopharmaceuticals, in particular monoclonal antibodies (mAbs). In such an analysis, it is possible to acquire peptide mass information, quickly confirm protein sequence, and post-translation modifications, as well as degradation related critical quality attributes. To support this application area, Waters has commercialized the mAb Trpytic Digestion Standard, which can be used in the benchmarking of LC-MS techniques, proficiency testing among different instruments and laboratories, and system suitability when performing peptide level protein analysis. This standard is a stabilized and lyophilized format of a refuced and alkylated tryptic digest of NIST Reference Material 8671 (NIST mAb), a humanized IgG1κ expressed from a murine cell line. Each vial of the stnadard is provided in an approximately 40 µg quantity.
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