Skin Irritation and Sensitization In Vitro Test for Live Biotherapeutic Products

In vitro skin tests using human, animal, and three-dimensional (3D) tissue substitutes effectively replace the traditional acute toxicity test model. This transformation is particularly evident in skin irritation and skin sensitization models, all of which are fully supported by Creative Biolabs.

What is Skin Irritation and Sensitization?

Skin is the largest human organ, composed of multiple layers, and has many vital functions for survival. One of them is to protect the human body from environmental hazards (such as toxic or corrosive substances). Therefore, in the preclinical safety evaluation of drugs, it is very important to determine the products that may cause skin irritation and allergy.There is a growing demand for alternative in vitro methods to replace animal testing and to be successful, new methods are required to be at least as accurate as existing in vivo tests.

Skin Irritation and Sensitization In Vitro Test Services

At present, various cell-based methods have been developed and used for the evaluation and/or ranking of skin irritants. Cell models include a monolayer culture of human and animal skin cells (keratinocytes), a multi-layer (3D) culture of skin cells providing barrier function similar to the skin surface, and a co-culture model of two or more cell types found in the skin. Creative Biolabs offers several in vitro skin tests to evaluate the skin sensitization and irritation potential of live biotherapeutic products, including but not limited to:

• Methods
  1. Reconstructed human epidermis test methods. OECD No.439.
  2. In vitro skin irritation test method (ET-50)
  3. In vitro skin irritation test method (SIT)
  4. ISO 10993
  5. USP <88>
• Samples
  1. Solids: two complete samples, each larger than 150cm² or 10g.
  2. Liquids: 30mL or above.
• Turnaround time
  8-10 weeks.
• Deliverables
  Upon completion of the test, a final report will be issued.

• Methods
  1. Direct peptide reactivity analysis (DPRA), OECD No.442C.
     A chemical method for evaluating protein activity by measuring the binding of applied products to synthetic peptides used to mimic skin proteins.
  2. Human Cell Line Activation Test (h-CLAT), OECD No.442E.
     A method for monitoring the expression of human monocyte surface markers in vitro.
  3. ARE-Nrf2 Luciferase Test Method, OECD TG442D.
  4. NF EN ISO 10993
• Samples
  1. Solids: two complete samples, each larger than 150cm² or 10g.
  2. Liquids: 30mL or above.
• Turnaround time
  8-10 weeks.
• Deliverables
  Upon completion of the test, a final report will be issued.

If you are ready to submit your samples for testing, please fill out the Sample Submission Form.

Advantages

• Based on cell models, through the use of related biological systems, the high amount of information expressed in the entire genome, and comprehensive bioinformatics, the determination of the most complex biological processes can be achieved.
• For a topical application or exposed live biotherapeutic products, an in vitro skin test to evaluate the possibility of skin irritation and skin sensitization is a key factor in their safety assessment.

Frequently Asked Questions

Both the existing technologies and the development of new and high-throughput in vitro toxicology methods at the level of genomics and proteomics have shown good consistency with in vivo tests. At Creative Biolabs, we have a team of experts dedicated to contributing to the field of in vitro toxicology and can support the testing needs of our customers from all over the world through standard analysis and customized methods. If you have any questions about our services, please contact us for more information.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.