Collagen Analysis

Collagen analysis is essential for the characterization and quality assurance of the many healthcare products that incorporate this extracellular matrix protein. These applications include wound care, cosmetics, burn care, orthopaedic graft products, tissue engineering scaffolds, hemostatic sponges, injectables for soft tissue augmentation, as a drug delivery vehicle and as an ingredient in skin and hair care products. Collagen is a highly versatile biomaterial, with sustained interest driven by its unique functional properties, structure, and good biocompatibility, as well as the expanding range of collagen sources, types, and processing methods being developed for new applications.

The chemical, physical, biochemical, biological, immunological, or toxicological properties of a collagen material may vary depending on the source and the processing treatment used. Any collagen-based biomedical device that moves to clinical development will need laboratory testing to support characterization and quality evaluation of the collagen component to establish collagen type, characterise chemical and physical attributes, and evaluate manufacturing process resdiuals. A range of quality, safety and efficacy tests may also be required for the finished product.

Collagen testing key parameters

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 to advance development or progress regulatory approval. We recognize the frequent requests from regulatory authorities for detailed information, as well as the diversity of testing needs from innovators using collagen in cosmetics. Drawing on our extensive experience, we apply the most suitable techniques to meet your specific requirements.

Collagen Type: Essential to characterization, we use SDS-PAGE and ELISA methods to determine the type.
Collagen Purity: We use SDS-PAGE to determine the purity of the collagen (checking for presence of other proteins or other types) 
Collagen Content/Purity: Hydroxyproline assay
Residual DNA: Single-stranded and double-stranded DNA by flurometric methods.
Impurities - Carbohydrates: Dosage adapted from the DUBOIS method
Impurities - Lipids: Colorimetric methods
Sulfated and non-sulfated Glycoaminoglycans: Analysis by capillary electrophoresis (CZE) and colorimetric assay (for chondroitin sulfate), For Non-sulfated: Analysis by CZE and ELISA
Microbiology: Total viable count (according to ISO 16212, ISO 21149 or ISO 11731), challenge testing (according to ISO 11930), endotoxin assay (accordgin to E.Ph 2.6.14)
Packaging Testing: Cosmetics packaging testing for safety and compliance

Why choose Intertek as your collagen testing partner?

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. Alongiside support for collagen in regenerative medicine, we also support the development of other biomaterials including hyaluronic acid, peptides and chitosan through analytical and biochemical testing.

• End‑to‑end testing from raw material screening to finished product
• Over 20 years of proven lab testing expertise
• Advanced characterization and contaminant screening
• Unique biochemical services for advanced and complex ingredients
• Experienced microbiology supporting quality and stability
• Comprehensive regulatory and toxicology support for global market launches

Collagen characterisation

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

Collagen biochemical testing

• SDS-PAGE Analysis (Type and Purity)
• ELISA (Type)
• Total DNA (ppm or %) 
• Total Lipid content 
• Sulfated and non-sulfated Glycoaminoglycans (GAGs) Levels
• Elastin and Albumin Assays
• Carbohydrates

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