Modular Protein Manufacturing Platform

This proposal focuses on developing a protein manufacturing platform based on a novel vector system that can rapidly and efficiently generate cell lines capable of producing proteins at high yield and purity in a short time period. Lentigen is able to perform such a quick protein manufacturing process based on its LentiMaxT lentiviral (LV) gene delivery technology that stably delivers one or more nucleic acid sequence(s) encoding a protein(s) to a mammalian cell with up to 100 % efficiency. Lentigen is able to produce multiple protein producing mammalian cell lines quickly, in as little as four (4) weeks, because its LentiMax system is inherently flexible and modular allowing all nucleic acid sequences under 6 Kb in length to be rapidly cloned. Transduction of cells with lentiviral particles is simple and cell lines theoretically should be able to produce protein indefinitely. Lentigen has monitored one cell line and has demonstrated that is has produced protein for up to three months with less than a 2 % decrease in yield over that time frame. Lentigen is currently working with four clients (the names of these clients can not be disclosed do to confidentiality constraints) to develop a plurality of cell lines able to produce monoclonal antibodies at high yields and purity for research and development purposes. To date, Lentigen has been able to generate in excess of 1 gram per Liter of Erythropoietin from cells that have been bulk transduced with LentiMax. This is a remarkable result given that the cells were not selected for high producers or manipulated in any way to increase protein production from routine cell culture conditions. Lentigen is confident that its LentiMax technology will be able to produce clonal cells that express secreted proteins of interest to an excess of 10 grams per Liter. Such an accomplishment would dramatically reduce the cost to produce valuable proteins such as monoclonal antibodies. Lentigen is applying for this STTR to adapt its protein manufacturing technology to be able to produce proteins in CHO cells, in serum free medium, for large scale clinical and commercial applications.