Founded in 1979, M-Scan has unrivalled experience and expertise as a problem-solving contract analytical laboratory. Mass Spectrometry, Chromatography and associated techniques are used for solving the most demanding problems in organic and biochemical analysis.
M-Scan are expert in biopharmaceutical and pharmaceutical product analysis, from small molecules through to NMEs, oligonucleotides, generics/biosimilars/follow-on biologics, peptides and proteins, glycoproteins or monoclonal antibodies. M-Scan provides a multi-disciplinary GLP/GMP analysis service. Also clients benefit from our vast experience dating back to the early 1980's. Since then, many hundreds of Biotech products have been analyzed in M-Scan's laboratories. Our extensive knowledge of the regulatory requirements enables us to guide clients on their analytical requirements. We were the pioneers of 'Peptide Mapping' by mass spectrometry and of several related protein characterization methods (e.g. S-S bridge assignment by mass spectrometry), which have become standard procedures worldwide.
Full-spectrum carbohydrate and glycan analysis, de novo sequencing and proteomics research are specialties and we have in-house capability to fully characterize to the requirements of the ICH guidelines. In all areas of biopharmaceutical characterization and pharmaceutical analysis we are able to use our considerable technical experience to guide clients in their choice of individual analyses.
We have a multi-disciplinary Chemical Analysis team, specializing in the fields of pharmaceutical, industrial, environmental and forensic chemistry. M-Scan holds the FIA contract for the analysis of Formula One Racing fuels. We developed the method for analysis of PFOS and are represented on the International Standards Organization (ISO) committee looking at best practice. We are at the forefront of developing methods for analyzing naphthanate scales and low-level mercaptan odors. Uniquely, M-Scan is capable of branding petrol used in arson attacks and in related work, our data has been used to obtain a criminal conviction, based on the analysis of smoke odors on a suspect's clothing.
The M-Scan group currently consists of four laboratories: M-Scan Ltd (UK), M-Scan Inc (USA), M-Scan SA (Switzerland) and M-Scan GmbH (Germany) supported by marketing offices and agents worldwide.
With experienced, skilful scientists and advanced technology, M-Scan is a recognized world leader in contract research analytical services, training and consulting. M-Scan is committed to maintain the highest level of quality in its analytical services and in all other elements vital to secure client confidence. In particular, it will continue its investment in new research in both method development and new analytical strategies and in the application of novel instrumentation as it becomes available and proven to be fit for purpose.
• Development of combined chromatography and MS techniques for the analysis of the product, as required in ICH Topic Q6A.
• Confirmation of identity of the API.
• Purity analysis on feedstocks.
• Analysis of process and product related impurities as in ICH Topics Q3A(R)/Q3B.
• Analysis of residual solvents as required by ICH Topic Q3C.
• Extractables and leachables from packaging/containers and closure systems.
• Validation of Cleaning Protocols to CFR Title 21 Part 211.67.
• Analysis of residual detergents used in cleaning.
• Analysis of VOCs and airborne product residues in manufacturing facilities.
• Full protein structural characterisation package, encompassing all the requirements of the ICH guidelines, particularly ICH Q6B.
• Amino acid sequence analysis, using automated sequencing and/or MS/MS.
• Amino acid composition analysis to provide protein concentration, extinction coefficient and/or molar amino acid ratios.
• N-Terminal and C-Terminal amino acid sequence analysis, using automated Edman chemistry and/or MS mapping/sequencing strategies.
• Peptide Mapping analysis, using digestion and MS strategies.
• Disulphide bridge analysis, using MS and MS/MS.
• Glycosylation analysis and characterisation.
• Identification of other post-translational modifications
• Determination of intact molecular weight by MS.
• Electrophoretic and isoform patterns, including CE.
• Liquid chromatographic patterns (RP-HPLC, SEC, IEX)
• Spectroscopic profiles – CD and NMR
• Analytical Ultracentrifugation (AUC).
• Identification of product related impurities, including degradation products (e.g. deamidation, oxidation, s-s bridge scrambling).
Examples of environmental analysis
• Analysis of groundwater and extracted fraction from soil by GC-FID, GC-MS
• Oil fingerprinting / branding gasoline
• Analysis of Nuisance Odor by Thermal Desorption GC-MS
• Analysis of Volatile Organic Carbons