Hello! how to predict shelf life of new proteins ( rec antigens) established based on stability testing (Long-term,Intermediate,Accelerated) In this - ICH Q1A http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html - only for New Drug Substances and Products
ICH Q5C http://www.ich.org/products/guidelines/quality/quality-single/article/stability-testing-of-biotechnologicalbiological-products.html - i didn t find testing protocol
iStable technique provides an accurate approach for prediction of protein stability changes.
Reference:
1.iStable is freely available online at: http://predictor.nchu.edu.tw/iStable.
2. Chi-Wei Chen, Jerome Lin and Yen-Wei Chu* (2013) iStable: Off-the-shelf Predictor Integration for Predicting Protein Stability Changes, BMC Bioinformatics, 14(suppl 2):S5, doi:10.1186/1471-2105-14-S2-S5.
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