ICH Q6B Test Procedures And Acceptance Criteria For Biophysical Characterization
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ICH Q6B is a guideline developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). It focuses on the specification of test procedures and acceptance criteria for biotechnological/biological products. Accepted by FDA, EMeA, and Japanese regulatory agencies, this guideline details standards for biotechnological/biological products, including composition determination, physical properties, and structure of the therapeutic protein.
| ICH Q6B Compliance Criteria | |
|---|---|
| Structural Characterization and Confirmation: |
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| Physicochemical Properties: |
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| Impurities: |
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Testing Procedures
CovalX provides comprehensive solutions for characterizing products in alignment with the ICH Q6B quality guidelines required for IND submission. Explore our offerings:
| Technique | |
|---|---|
| Application | |
| Hydrogen–Deuterium Exchange MS (HDX–MS | Epitope mapping / Conformational Analysis |
| Cross–linking MS (XL–MS) | Epitope mapping; provides both epitope and paratope information |
| Immunoprecipitation–MS (IP–MS) | Protein ID; identify protein–protein interactions within cells |
| Peptide Mass Fingerprinting (PMF) | Verifying known protein sequence |
| Post Translational Modifications (PTMs) | Identification of post translational modifications on the protein structure |
| Disulfide Bridge Mapping | Identification of disulfide bonds present within a protein sample |
| Free Sulfhydryl Analysis | Identification of free sulfhydryls present within a protein sample |
| Glycosylation sites | Identification of glycosylation sites within a protein sample |
| Size exclusion chromatography (SEC) | Purity analysis; separates based on size |
| Reverse–phase HPLC | Purity analysis; separates based on polarity |
| Circular Dichroism (CD) | Determination of protein secondary structure features |
| Multi–Angle Light Scattering (SEC–MALS) | Identification of protein aggregates |
| Analytical Ultracentrifugation (AUC) | Identification of protein aggregates |
| Fourier Transform Infrared Spectroscopy (FTIR) | Determination of secondary structure in protein |
| Differential Scanning Calorimetry (DSC) | Thermal stability of the protein |
| Dynamic Light Scattering (DLS) | Identification of protein aggregates |
| Cation–Exchange Chromatography (CEX–HPLC) | Purity analysis; separates based on charge |
| Capillary Electrophoresis (CE–SDS) | Purity analysis; separates based on size/charge |
| Capillary Isoelectric Focusing (cIEF) | Purity analysis; separates based on isoelectric point |
| Surface Plasmon Resonance Analysis (SPR) | Binding affinity analysis |
| Monosaccharide Composition | Quantification of potential harmful monosaccharides |
| Oligosaccharide Linkage Patterns | Identification of glycan structure |