EMA reviewed 88 articles and published a review looking at non-animal models for immunogenicity. The announcement notes the creation of a knowledge base, a technical report and executive summary.
From the announcement: Key findings
- The majority of the advanced non-animal models have been used to test cell therapy products.
- A great number of non-animal approaches used to test the immunogenicity of ATMPs were based on in vitro methods that mainly use cells and tissues cultured in the laboratory.
- In contrast, it was found that computational and mathematical modelling (in silico methods) were less commonly used.
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| Immunogenicity testing for ATMPs |
| The JRC's EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) carried out a study to review the state-of-the-art of advanced non-animal models in use for immunogenicity testing in advanced therapy medicinal products (ATMPs) and selected 88 papers describing innovative models. |
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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