M-Scan has unrivalled expertise in protein analysis. We are the originators of MS Mapping of biotechnology products, together with other mass spectrometry strategies related to protein / glycoprotein analysis which have become standards worldwide. M-Scan's protein analysis package is designed to encompass the requirements of the ICH guidelines (particularly ICH Q6B), the US FDA 'Points to Consider' documents and the concept of a 'well characterized' or 'specified' biological product. Individual analyses, or the full protein analysis package, are available to GLP or GMP, including:
| ICH Q6B requires | M-Scan provides | ICH Q6B requires | M-Scan provides |
| Amino Acid Sequencing | Amino Acid Analysis | ||
| N - Terminal Sequencing | C - Terminal Sequencing | ||
| Peptide Mapping by MS | S-S Bridge Analysis | ||
| Glycosylation Analysis | Molecular Weight Information | ||
| Isoelectric Focusing | SDS-PAGE | ||
| Extinction Coefficient | Post-Translational Modifications | ||
| Spectroscopic Profiles: CD, NMR | Liquid Chromatography: SEC, RP, IEX |
Identification of process and product related impurities, including degradation products (e.g. deamidation, oxidation, mis-matched S-S bridge forms), may be included in the protein analysis package. Also, research-level AUC is available.
M-Scan Brochure: Biotechnology and Pharmaceutical Analysis (8pp.)