Premade Plasmid Advantages 

The four-plasmid vector system independently developed by Jiangsu Hillgene meets the compliance and traceability of plasmid production, and efficiently supports lentiviral packaging, showing excellent infection efficiency at low MOI for T cells.

·Premade plasmids: GMP-grade premade plasmids can meet the needs for different stages of a project;

·The four-plasmid vector system greatly reduces the possibility of RCL production and increases the safety of the vector system;

·The inclusion of modified WPRE elements can enhance the expression of target genes while taking into account safety (modified WPRE highlighted);

·The only compliant Kana resistance gene of marketed cell drugs was used for resistance;

·The optimization and modification of possibly carcinogenic sequences (the modification of wild-type WPRE elements to express the sequence of truncated X protein can avoid the risk of cancer);

·The optimization of promoter selection can take into account both efficiency and safety;

·After obtaining the DMF filing number, it can be directly cited in the IND application of FDA to provide detailed pharmaceutical study information;

·The IND application dossier of three helper plasmids has helped a number of cell drugs such as CAR-T and TCR-T obtain implied approval for clinical trials around the world.

Master File Acknowledgement Letter from FDA CBER

Premade Plasmid Particulars