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Scalable THL manufacturing using ethanol dilution to encapsulate the plasmid DNA within small 100–150 nm vesicles, and using tangential flow filtration (TFF) with a 100 kDa molecular weight cut-off (MWCO) to remove the nuclease and ethanol, and a second TFF with a 300 kDa MWCO to remove the unconjugated MAb. The final THL formulation is sterile filtered, and lyophilized for long term storage. hrDNaseI, human recombinant DNase I.
