Darell D. Bigner,Vidyalakshmi Chandramohan,Charles Pegram
申请号：
US16342914
公开号：
US20200046847A1
申请日:
2017.10.13
申请国别(地区):
US
年份:
2020
代理人:
摘要：
D2C7-(scdsFv)-PE38KDEL (D2C7-IT) is a recombinant Pseudomonas exotoxin A-based immunotoxin (IT), targeting both wild-type epidermal growth factor receptor (EGFRwt) and mutant EGFR variant III (EGFRvIII) proteins overexpressed in glioblastomas. A good laboratory practice (GLP) manufacturing process was developed to produce sufficient material for a Phase I/II clinical trial. D2C7-IT was expressed under the control of the T7 promoter in Escherichia coli BLR (λ DE3). D2C7-IT was produced by a 10 L batch fermentation process and was then purified from inclusion bodies using anion exchange, size exclusion, and an endotoxin removal process that achieved a yield of over 300 mg of purified protein.
