Scribd Logo
Upload

Welcome to Scribd!

  • ICH Q6B Service Leaflet

    Uploaded by

    M-Scan
    300 views2 pages
    Protein Analysis to GMP / GLP 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. 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: - 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

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    Protein Analysis to GMP / GLP 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. 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: - 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

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    300 views2 pages

    ICH Q6B Service Leaflet

    Uploaded by

    M-Scan
    Protein Analysis to GMP / GLP 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. 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: - 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

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 2

    Protein and Expert

    Glycoprotein Analytical
    Analysis Services
    in Accordance with ICH Guidelines
    (ICH Q6B)

    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.

    M-Scan provides a full analysis package for physicochemical


    characterisation to GLP/cGMP.

    ICH Q6B requires M-Scan provides


    Amino Acid Sequencing ü
    Amino Acid Composition ü
    N- and C-Terminal Sequencing ü
    Peptide Mapping ü
    S-S Bridge Analysis ü
    Glycosylation Analysis ü
    Post Translational Modifications ü
    Molecular Weight ü
    Isoform and Electrophoretic Patterns ü
    Extinction Coefficient ü
    Liquid Chromatographic Patterns ü
    Spectroscopic Profiles ü
    Process and Product Related Impurities ü
    Aggregation Analysis ü

    Please see the web-site for your local marketing office

    www.m-scan.com
    Protein and Expert
    Glycoprotein Analytical
    Analysis Services
    M-Scan provides a full analytical package or individual analyses
    depending on your needs:

    Amino acid sequence analysis using automated Edman


    sequencing and/or MS/MS

    Amino acid composition to provide protein concentration,


    extinction coefficient and/or molar amino acid ratios

    N- and C-Terminal analysis using automated Edman and/or


    MS sequencing

    Peptide Mapping by MS

    Disulphide bridge analysis using MS and MS/MS

    Glycan characterisation including:

    Monosaccharide composition
    Sialic acid analysis
    Oligosaccharide population
    Linkage analysis
    Glycosylation site determination

    Identification of post-translational modifications e.g.


    acetylation, phosphorylation etc

    Determination of intact molecular weight by MS

    Electrophoretic and isoform patterns - isoelectric focusing,


    cIEF and SDS-PAGE

    Liquid chromatographic patterns - RP-HPLC, SEC and IEX

    Spectroscopic profiles - CD and NMR

    Aggregation by AUC and SEC/MALLS

    Analysis of process and product related impurities and


    degradation products e.g. isomerisation, deamidation,
    oxidation, mismatched S-S bridge forms

    Extractables and leachables from packaging/containers and


    closure systems by MS

    Validation of Cleaning Protocols to CFR Title 21 Part 211.67


    using TOC

    Analysis of residual solvents by TD GC-MS


    Please see the web-site for your local marketing office

    www.m-scan.com

    You might also like