Protein Analysis to GMP / GLP

SGS 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.

SGS 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

SGS M-Scan provides

ICH Q6B requires

SGS 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, AUC is available.