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See channels. A commercially available peptide mixture may serve this purpose. It is preferable that the sample is not just a mixture of synthetic peptides, but a peptide mixture resulting from the digestion of an appropriate protein.
Learn how innovation and monitoring strategies can reduce the number of tests and enhance the methodology of validating impurity.
Get a robust and reproducible, automated digestion time-course protocol to determine the optimal digest time for a biotherapeutic during development of a peptide mapping method.
Connect Your Lab Anmelden Eilbestellung. Search Thermo Fisher Scientific. Search All. Biopharmaceutical Multi-Attribute Method. Navigationsleiste anzeigen.
What is MAM? What is the Multi-Attribute Method? The benefits of an optimized and standardized Multi-Attribute Method for characterization of biologics and later stage quality control include: High-resolution MS data for absolute identification and confidence in analytical control over quality A single method providing the same or superior product quality information instead of many traditional methods and techniques A single assay that offers cost and time savings, as well as fewer SOPs and instruments to maintain Offering consistently reliable analytical processes on multiple instruments across different development sites, from research and development to manufacturing and QC Accepting and standardizing MAM from development into QC space will offer peace of mind when preparing regulatory filings The Thermo Scientific HR Multi Attribute Method includes all the abovementioned benefits in a locked down workflow product.
Benefits of a Multi-Attribute Method Workflow. Comprehensive characterization. Comprehensive characterization in line with Quality by Design principles.
Fewer assays, reduced complexity. Fewer assays and reduced analytical complexity with high resolution MS. Implementing a Multi-Attribute Method workflow.
The key components of a MAM workflow are:. Sample preparation and digestion strategies. Peptide separation.
Peptide detection and quantitation with HRAM. Article: Mass spec weighs in on protein therapeutics. Software for a successful MAM.
For compliance-ready QC monitoring, the data processing software, such as Chromeleon CDS , can: operate the LC-MS system in a 21 CFR Part 11 compliant fashion acquire high resolution MS1 only data on a peptide digest of all future lots of the biologic drug, automatically compare the relative abundances of CQAs between a reference standard e.
The software must support: Discovery peptide mapping for identification of product quality attributes and allowing the user to build a peptide list for monitoring Confirmation of amino acid sequence Identifying the site and type of expected and unknown PTMs and providing the relative amount of the modification in the sample Disulfide bond mapping Determination of low-level impurities — sequence variants Detection of sequence alterations — in stress samples, level of deamidation or oxidation Instrument control and routine data processing Data measurement control in a compliance-ready environment Quantitation of peptides Detecting new peaks Reporting.
System suitability testing. Featured video. HR Multi-Attribute Method animation Learn how innovation and monitoring strategies can reduce the number of tests and enhance the methodology of validating impurity.
MAM workflow resources. Application note. Automated biopharmaceutical protein digestion optimization for peptide mapping method development Get a robust and reproducible, automated digestion time-course protocol to determine the optimal digest time for a biotherapeutic during development of a peptide mapping method.
Case study. The future for the multi-attribute method MAM in the biopharmaceutical industry Rich Rogers, president of the MAM Consortium, discusses his vision of the future for the Multi-Attribute Method in the biopharmaceutical industry.
Thermo Fisher Scientific Inc. CDR Conformers. CDR Tryptophan Degradation. C-terminal Amidation. C-terminal Lysine.
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