This guide outlines the basic steps of the Thermo Scientific™ MAM 2.0 workflow. The workflow is designed for the characterization and monitoring of the quality attributes of your biopharmaceutical products at the peptide level. Integration with the Thermo Scientific™ Ardia™ Platform makes the Thermo Scientific MAM 2.0 workflow a solution for seamless knowledge sharing and method transfer.

MAM 2.0 workflow
Target PeptideWorkbook Reporting Targeted Quantitation and New Peak Detection LC/MS Data Acquisition - Full MS only CQA Selection and Workbook Transfer for Method Generation Peptide Mapping and Attribute Mining LC/MS 2 Data Acquisition Protein Digest

After you have installed, configured, and qualified your system, the principal stages of the MAM 2.0 workflow are the following:

  1. Characterizing your digested protein using liquid chromatography (LC) separation hyphenated to mass spectrometry (MS) detection, which uses a method comprising full-MS scans and data-dependent MS2 (ddMS2) scans.
  2. Processing the full-MS / ddMS2 data to identify the product quality attributes (PQAs), a subset of which is monitored in the quality and control phase, and designing the processing method for the monitoring.
  3. Simplifying the processing method so that it uses full-scan MS data without ddMS2 scans.
  4. Designing the system suitability test (SST) method and report design for summarizing the monitoring results.
  5. Transferring the PQA monitoring method from the research and development phase to the routine quality control phase.

NOTE

PQAs that meet specific criteria might also be known as critical quality attributes (CQAs) or by other specialized terms. It is at the discretion of the user if and from what stage an attribute is considered and referred to as a CQA. In this document, all quality attributes are referred to as PQAs.