Collagen analysis supporting product development, authorisation and manufacturing through characterisation, biochemical analysis & impurity profiling
Collagen analysis helps to characterise and ensure that safety of a multitude of healthcare products that incorporate this extracellular matrix protein. These applications include wound care, burns care, orthopaedic graft products, tissue engineering, hemostatic sponges, injectables for soft tissue augmentation, as a vehicle for drug delivery and as an ingredient in skin and hair care products. Collagen is a highly versatile material and there is a growing interest in the processing and characterisation of many types of collagen as developers find new applications.
The chemical, physical, biological, immunological, or toxicological properties of a collagen material may vary depending on the source material and the processing treatment used to process the collagen. If you are developing or manufacturing a collagen-containing biomaterial, collagen analysis via the most suitable test methods is required to clearly identify the specific collagen material, its properties and the presence of process residuals.
Our collagen analysis scientists offer characterisation services, including physical and biochemical analysis and impurity profiling with expertise in the delivery of multi-technique analytical packages that give you the insight you need to progress development or achieve regulatory approval.
We understand that regulatory authorities frequently request more detailed information. Our experience means we apply the most suitable technique to meet your requirements. In the assessment of processing effects on collagen structure, for example, we apply SDS-PAGE for molecular weight determination and circular dichroism to study the ordered structure versus unordered structures which can indicate breakdown and loss of structural integrity.
We can deliver analysis to Good Laboratory Practice (GLP) or Good Manufacturing Practice (GMP) standards. Our team have extensive experience in data provision for regulatory submission packages for multiple regions around the globe and have worked with many clients to characterise their collagen products and other tissue scaffold materials.
- Collagen Content / Purity (Hydroxyproline Determination)
- Amino Acid Analysis
- Total Protein Content
- Moisture Content
- SDS-PAGE Analysis
- Total DNA (ppm or %)
- Total Lipid content
- Trypsin Resistance
- Collagenase Resistance
- GAGs Levels
- Gelatin Testing according to European Pharmacopeia
- Elastin Assay
- Viscosity (Mainly soluble samples)
- TEM or SEM - Electron Micrograph (native banded 640 Å structure for fibrils sizing and D-spacing.
- Mechanical Testing (e.g. tensile strength)
- Light Microscopy
- Surface Characterisation
- Heavy Metal Analysis
- Additives (cross-linkers, lubricants, drugs, sterilants)
- Process Residuals (antibiotics, detergents, etc)
- Host Cell Contaminants
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