TriCleanse Process
Effective decellularization is an important process in the production of ECM-based scaffolds for therapeutic applications.1 The presence of intact cells within an ECM can lead to an inflammatory response.2 The goal of effective decellularization is to remove the cells and genetic material, and to reduce immunogenicity, while preserving the collagen structure.3,4
Our proprietary TriCleanse process effectively decellularizes the ECM by removing cells and cellular debris, while maintaining composition integrity.4,5
Processing Matters
Convatec's production facility was specifically designed to meet the rigorous ISO 13485 standards, including ISO Class 7 clean rooms, and is staffed with highly trained technicians.6,7,8 This ensures each product not only meets regulatory requirements but also maintains Convatec's highest standards of safety and quality.
Because tissue processing for ECM membranes has evolved over time and is performed by numerous processors, it is essential to understand that not all processes are similar.
Process variables may affect the processed tissue in multiple ways, including residuals from the processing chemicals, moisture content, and high levels of residual cellular debris.4,2
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References
- Keane, T. J., Londono, R., Turner, N. J., & Badylak, S. F. (2012). Consequences of ineffective decellularization of biologic scaffolds on the host response. Biomaterials, 33(6), 1771- 1781. doi:10.1016/j.biomaterials.2011.10.054
- Londono R, Dziki JL, Haljasmaa E, Turner NJ, Leifer CA, Badylak SF. The effect of cell debris within biologic scaffolds upon the macrophage response. J Biomed Mater Res A. 2017 Aug;105(8):2109-2118. doi: 10.1002/jbm.a.36055. Epub 2017 Apr 12. PMID: 28263432
- Gilpin A and Yang Y. Decellularization strategies for regenerative medicine: From processing techniques to applications. Biomed Res Int, 2017, 9831534. doi:10.1155/2017/9831534
- RDR-002
- Badylak MEMO-001
- ISO 13485 certification MD 800125
- ISO 13485 certification MD 800126
- Annual Certification of the cleanrooms from Environmental Test & Balance Company 2024