Scientific Best Practices for Primary Sequence Confirmation and Sequence Variant Analysis in the Development of Therapeutic Proteins

In this commentary, we will provide a high-level introduction into LC-MS product characterization methodologies deployed throughout biopharmaceutical development. The ICH guidelines for early and late phase filings is broad so that it applicable to diverse biotherapeutic products in the clinic industry pipelines. This commentary meant address areas of protein primary sequence confirmation variant analysis where ambiguity exists on specific scope work needed fulfill general guidance given sections Q5b Q6b. highlights discussion outcomes two recent workshops centering application structure (SVA) were held at 2018 2019 CASSS Practical Applications Mass Spectrometry Biotechnology Industry Symposia San Francisco, CA Chicago, IL, respectively. Recommendations from conferences fall distinct but related areas; 1) consolidation opinions amongst stakeholders definitions peptide mapping sequencing technologies used both, as they relate regulatory expectations submissions 2) development fit-for-purpose strategy define appropriate assay controls SVA experiments.