MORRE, MICHEL CHRISTIAN,ASSOULINE, BRIGITTE,CORTEZ, PIERRE,GREGOIRE, ANNE
申请号：
CA2494974
公开号：
CA2494974C
申请日:
2003.08.06
申请国别(地区):
CA
年份:
2014
代理人:
摘要：
The present invention relates, generally, to the fields of immunology andmolecular biology. The invention discloses, more particularly, new andimproved interleukin-7 drug substances, corresponding specific immunoreactiveantibodies, as well as compositions comprising the same, their preparation anduses. The invention also discloses methods to characterize the impurityprofile of a r-hIL-7 drug substance used for therapeutic purpose, as well asoptimized nucleotide sequences encoding mammalian IL-7, recombinant expressionvectors and methods for preparing and purifying said polypeptides. The presentinvention stems from the unexpected discovery that the long term activity ofrecombinant IL-7 is mostly expressed by a specific conformer and that otherconformers, potential product-related substances, product-related impurities,and process-related impurities, which would normally be included in thespecification of the drug substance and/or drug product, although bioactive,should be strictly minimized because they are able to trigger an immunereaction against the desired IL-7 molecule.
