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SGS M-Scan Protein and Glycoprotein Analysis

Biosimilar Development: From Science to Market

This short paper gives the essential background to an understanding of biopharmaceutical characterization by mass spectrometry and its importance in accelerating the processes leading to the approval by the regulator of well-characterized new drug products.

M-Scan is an independent group of companies dedicated to providing high quality mass spectrometry and related analytical services in the Life Sciences arena.

Biotechnological and biological products should be characterised according to ICH Guidelines. ICH Topic Q6B outlines procedures for analysis of peptide, protein, glycoprotein and antibody products.

Structural Analysis of Glycans For over 30 years M-Scan has provided a full analytical package for carbohydrate analysis, including novel structure elucidation. Monosaccharide Composition Analysis, Glycan Population Analysis, Glycan Antennary Profiling Analysis Linkage (methylation) analysis Glycosylation Site Analysis

Antibody products should be characterised according to ICH and FDA guidelines. M-Scan provides a full GLP/cGMP analysis package for product characterisation and identification of post translational modifications, which include...

M-Scan has developed mass spectrometry based validated methods for the analysis of plasticisers and leachables from rubber seals, tubing and containers, as well as analysis methods for other extractables. --- | --- M-Scan offers analytical expertise in the detailed identification and quantification of residual solvents in medicinal products, using proven robust techniques.

by Dr Fiona M Greer and Dr Andrew J Reason. European BioPharmaceutical Review Summer '02 issue.

by Dr Fiona M Greer and Dr Richard L Easton. European BioPharmaceutical Review Winter '06 issue.

by Dr Fiona M Greer. European BioPharmaceutical Review Summer '03 issue.

by Dr Fiona M Greer. Article from SP2 Magazine, Nov 2006 (reprint)

(MS06) The course will provide a detailed review of product characterisation, seeking to answer questions such as What characterisation should be performed and when? and How do product characterisation and analysis impact the development programme?’

(MS03) The technical content of the Course will deal firstly with an understanding of the different types of ionisation method and mass spectrometer best suited to the study of Biopolymer sequencing, and this includes an explanation of the concept of collision induced dissociation tandem MS/MS analysis...

(MS01) The Introductory Course will cover the most important Ionisation techniques used in Mass Spectrometry, including: Electron Impact, Matrix Assisted Laser Desorption and Electrospray together with descriptions of the most common mass analysers, and how to choose the correct combination for the problem under study.

Directive 2001/82/EC

Directive 2004/9/EC

(Art.14 para.3 Ordinance on GLP [RS813.211.1])

(§19b Chemikaliengesetz and Directive 88/320/EEC)

(§14 para 4 No.3, German Drug Law (AMG))