ICH Q6B
This guidance document ICH Q6B provides a uniform set of internationally accepted specifications for the characterization of biotechnological and biological products to support new marketing applications.
These specifications establish the set of criteria to which a drug substance, drug product or materials at other stages of the manufacturing process should conform in order to be considered acceptable for its intended use. They are one part of the total strategy designed to ensure both product quality and consistency.
Although ICH Topic Q6B does not recommend specific test procedures or specific acceptance criteria it suggests technical approaches which may be considered to provide the following information for biotechnological or biological products:
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Analysis
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Goal
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Established
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1. Structural characterization
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Amino acid sequence
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Amino Acid Sequence of protein as compared to theoretical sequence
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✓
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Amino acid composition
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Amino acid composition of unknown protein
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✓ |
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N/C-terminal sequencing
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Identify nature and homogeneity of termini
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✓
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Peptide map
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Confirm identity of protein after digestion
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✓
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S-S-Bridge analysis
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Confirm location and /or connectivity of S-groups
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✓
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Glycosylation analysis
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Sugar content and further analysis (structure, modification site)
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✓
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2. Physicochemical properties
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Molecular weight (MW) and size
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MW of protein
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✓
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Isoform pattern
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Relative quantification of all isoforms
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✓
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Extinction coefficient (EC)
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EC of known substance
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✓
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Electrophoretic patterns
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Show the identity, homogeneity and purity of a substance
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✓
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Liquid chromatographic patterns
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Show the identity, homogeneity and purity of a substance
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✓
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Spectroscopic Profiles
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Determine higher-order structure
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Via Partner
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3. Process- and product-related impurities
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Host cell proteins
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Find contamination via host cell proteins
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✓
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Truncated forms
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Find truncated forms of a protein
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✓
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Post-translational modifications (PTM)
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Identification of PTMs
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✓
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Aggregates
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Find protein complexes
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✓
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Protagen AG provides a strategic approach for characterizing your biopharmaceutical products. Analysis is performed in a GMP compliant laboratory using validated techniques to satisfy the latest regulatory requirements.
Your contact for ICH Q6B at Protagen AG
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Dr Katja Aschermann
Head of Business Development Protein Services.
Her team will be happy to assist you with your project.
Phone: +49 (0) 231 9742-6300
Email: salesproteinservices@protagen.de
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ICH Q6B