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filingDate 2016-08-17-04:00^^<http://www.w3.org/2001/XMLSchema#date>
grantDate 2021-07-19-04:00^^<http://www.w3.org/2001/XMLSchema#date>
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publicationDate 2021-07-19-04:00^^<http://www.w3.org/2001/XMLSchema#date>
publicationNumber ES-2843558-T3
titleOfInvention Improved refolding process of antibody fragments
abstract A process for recovering refolded ranibizumab, the process comprising the steps of: a) isolating inclusion bodies comprising a ranibizumab light chain and heavy chain from the bacterial host cell; b) solubilizing said inclusion bodies comprising a ranibizumab light chain and / or heavy chain in a first buffered solution comprising 10 mM Tris-Cl to 60 mM, 6 M to 8 M urea and DTT at a pH in the range of 8.5 to 10; c) refolding the light chain and the solubilized heavy chain of ranibizumab in a second buffer solution comprising 0.1 M arginine to 1 M, 1% sorbitol to 8% and 10 mM Tris to 60 mM having a pH in the range from 10 to 11 and a temperature in the range of 4 to 12 ° C for a first incubation period of 1 to 25 hours and then change the pH and temperature of the first incubation period to a pH in the range of 8 at 9 and a temperature in the range of 20 ° C to 30 ° C for a second incubation period of 1 to 25 hours; and d) recovering said refolded ranibizumab.
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