Characterization of lentivirus for use in individualized cell-gene therapy

Division Of Basic Sciences - Nci

Investigators

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Abstract

This is a new project as of January 2021. The initial experiments are centered around establishing a baseline for comparison to the proposed lentiviral system and the development of the system and protocols to generate lentivirus suitable for clinical T-cell transductions. Critical variables of the lentivirus evaluation is the selection of promoter (EF1a, CMV or MSCV LTR), lentivirus production method (concentrated vs unconcentrated), transduction protocol (incubation vs spinoculation) and use (or concentration) of OKT3 required for T-cell stimulation and activation. Once the establishment of lentivirus production parameters is set - at scale experiments will be performed with the intention of transitioning to a GMP production platform: 1. Complete one cell production run at GMP scale using retrovirus. a. Retrovirus produced using current GMP SOPs. b. Cells manufactured following current GMP SOPs. 2. Complete 2-3 cell production runs at GMP scale using lentivirus. a. Lentivirus produced and concentrated using research methods comparable to planned GMP SOPs. b. Cells manufactured using research methods comparable to planned GMP SOPs. i. High cell number and virus MOI of TBD for transduction. ii. Current 10 day cell manufacturing processes under process development.