Protein Analysis to GMP/GLP
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. Analyses are available to GLP or GMP, including: - Amino Acid Sequencing- Amino Acid Analysis- C-terminal Sequencing- N-terminal Sequencing by Edman degradation and/or mass spectrometry- Peptide Mapping by mass spectrometry (MS)- Disulphide Bridge Analysis- Glycosylation Analysis, including oligosaccharide profiling, sialic acid analysis, monosaccharide composition analysis and linkage analysis- Molecular Weight Information- Isoelectric Focusing (IEF) and capillary Isoelectric Focusing (cIEF)- SDS-PAGE- Extinction Coefficient- Post-Translational Modifications- Spectroscopic Profiles: Circular Dichroism and NMR - Liquid Chromatography: SEC, RP, IEX- Aggregation Analysis: Analytical Ultracentrifugation (AUC) and SEC-MALSThe protein analysis package can be tailored to our clients' needs - selected individual analyses, or the full protein analysis package in accordance to the ICH Q6B guidelines is provided to GLP or GMP.