Collagen Analysis

Collagen analysis helps to characterise and ensure the 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 identify the specific collagen material, its properties and the presence of process residuals.

Our collagen analysis scientists offer comprehensive characterization services, including physical and biochemical analysis, as well as impurity profiling. We specialize in delivering multi-technique analytical packages that provide essential insights for advancing development or achieving regulatory approval.

We recognize the frequent requests from regulatory authorities for detailed information. Drawing on our extensive experience, we apply the most suitable techniques to meet your specific requirements. Our team has a proven track record in preparing data for regulatory submission packages across various global regions. We have collaborated with numerous clients to characterize their collagen products and other tissue scaffold materials. We also support through analytical and biochemical testing the development of other biomaterials including hyaluronic acid and chitosan.

Collagen Characterisation

• Collagen Content / Purity (Hydroxyproline Determination)
• Amino Acid Analysis 
• Total Protein Content
• Moisture Content

Collagen Biochemical Characterisation 

• SDS-PAGE Analysis 
• Total DNA (ppm or %) 
• Total Lipid content 
• GAGs Levels
• Elastin Assay

Collagen Physical Characterisation 

• 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

Collagen Impurities Profile 

• Heavy Metal Analysis 
• Additives (cross-linkers, lubricants, drugs, preservatives) 
• Process Residuals (antibiotics, detergents, etc.) 
• Host Cell Contaminants