ISO 10993, IN VITRO AND EX VIVO STUDIES
CELL CULTURE TESTING
Ex vivo and in vitro testing to ISO 10993 guidance and also GLP complaint. Perfectus Biomed specialise in cell culture and biocompatibility testing to support the biological evaluation of your product.
The body responds to foreign bodies, even relatively inert biomaterials, with inflammation, an integral part of the healing process. However, sustained inflammation may indicate chronic infection or foreign body response, resulting in fibrosis, encapsulation, and consequent failure of implantable devices. It is critically important to consider the host inflammatory response when developing products such as antimicrobial formulations, cosmetics and skincare products, implantable devices, and wound dressings.
We use in vitro wound models and cell models to aid biocompatibility assessments, using ISO 10993 guidance, to measure parameters such as cytotoxicity (USP 87), hemocompatibility, irritation, corrosion, and proliferation viability. Testing to GLP is also available.
Our US laboratory offers a range of ex vivo studies including human tissue models to test product antimicrobial efficacy, biomarker assessments and host cell toxicity on wounded and unwounded skin.
Perfectus Biomed work closely with our clients, from study design to production of the scientific report.
We typically offer cell services to support our clients for one of three reasons:
- Research and Development: product development, screening and pre-clinical data.
- Biocompatibility and Safety/Regulatory Requirements: legal requirements and label claims.
- Marketing: evidence to support the product on the market by highlighting competitive advantages, differentiations and USPs.
Marketing and Research & Development
- Scratch wound model: in-house method
- Conference abstracts and presentations
Biocompatibility and Safety Testing
- In vitro cytotoxicity: BS EN ISO 10993-5
- In vitro skin irritation using 3D reconstructed human epidermis: OECD 439
- In vitro skin corrosion using 3D reconstructed human epidermis: OECD TG431
- Ex vivo human skin model (US laboratory)
- Ex vivo skin model
- Ex vivo mucosal model
Regulatory and Label Claims
- In vitro virucidal activity: BS EN 14476
- Macrophage activation assay (assessment for inhibition)
- Colonised skin model: in-house method
We help companies to accelerate their pipeline, expand product claims and highlight competitive advantages with testing available in both the UK and USA.
- Biocompatibility testing – ISO 10993-3: Tests for genotoxicity
- Biocompatibility testing – ISO 10993-4: Interaction with blood
- Biocompatibility testing – ISO 10993-5: in vitro cytotoxicity – Direct contact
- Biocompatibility testing – ISO 10993-5: in vitro cytotoxicity – Indirect contact
- USP 87 – Cytotoxicity
- In vitro scratch wound closure
- Gel contraction assays
- EpiSkin Reconstructed Human Epidermis – Skin Irritation Assay
- EpiSkin Reconstructed Human Epidermis – Skin Corrosion Assay
- Macrophage activation
- Co-culture with monolayer
- MMP concentration assessments
- Acne models
- Phenotypic screening of drugs
- Basic gut epithelial models
- Cancer invasion assays
- Molecular analysis – pathway targeting
- Cytokine measurement
- Growth factor measurement
- Measurements of extracellular matrix components
- Protease measurement
- Colonized skin models
- Standard anti-viral testing
- Cell proliferation/viability
- Collagen production
- Wound closure in 3D skin
- Biofilm-wound models
- Antiviral fogging
- Corneal model (bacterial adhesion, eye irritation)
- Oral models (oral care, bacterial adhesion)
- Vaginal models (feminine hygiene care/bacterial adhesion)
- Diabetic models
- Gut microbiome models
- Biocidal activity against parasites
Human Cell Types:
- Human dermal fibroblasts (normal, adult)
- Human epidermal keratinocytes (normal, neonatal)
- HeLa (epithelial, adenocarcinoma)
- H1-HeLa (epithelial, adenocarcinoma, viral susceptibility)
- HEK-293 (epithelial, contain adenovirus DNA)
Animal Cell Types:
- Vero (epithelial, normal)
- L-929 (fibroblast, normal)
- RAW 264.7 (macrophage, Abelson murine leukemia virus-induced tumor)
- MDCK (epithelial, norma