Protein Analysis to GMP/GLP

Protein Analysis to GMP/GLP from M-Scan Ltd

By: M-Scan Ltd  11/11/2009
Keywords: Recombinant Protein, Protein Analysis, Protein Sequencing

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)
- Extinction Coefficient
- Post-Translational Modifications
- Spectroscopic Profiles: Circular Dichroism and NMR
- Liquid Chromatography: SEC, RP, IEX
- Aggregation Analysis: Analytical Ultracentrifugation (AUC) and SEC-MALS

The 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.

Keywords: Glycan analysis, Glycoprotein, Glycosylation Analysis, ICH Q6B guidelines, Peptide Mapping, Protein Analysis, Protein Sequencing, Recombinant Protein,