Streamlining Production of Biologics, Vaccines and Cell-Based Medicines Using a Single Fully Scalable Transfection Platform

摘要

Companies must efficiently identify, develop, and quickly bring to market new therapeutics — whether a biologic, vaccine or cell-based medicine — with the highest level of efficacy at the lowest cost. Many approaches have been adopted to meet those goals including i). using transient gene expression (TGE) for early-stage development; ii). working in the same cell background from early-stage development through clinical application; iii). postponing the generation of stable cell lines until a reasonable number of candidates are identified; and iv). using a cell- or gene-therapy production system that meets the safety and scalability needs for use in humans. A technology that underlies all these approaches is cell modification via transfection. In this poster we demonstrate how MaxCyte electroporation, a universal method of transient transfection able to transfect up to 2x1011 in a single run, has the flexibility to work in the cell line of choice, the scalability to meet early through late-stage development and bioproduction needs, the robustness for high yield expression of a variety of proteins, and the performance and safety required for use in human therapeutics. Specifically data are presented showing gram-scale production of a therapeutic antibody using CHO cells, the streamlined generation of high-yield stable cell lines with a titer of 5.7 g/L within 6-8 weeks of transfection and the scale up of lentivirus production without protocol reoptimization. Additionally data are shown highlighting the high cell viability and transfection efficiency of MaxCyte electroporation for use in immunotherapy. In summary, we demonstrate the ability of MaxCyte Transfection Systems to meet the needs of the development and bioproduction of biologics, vaccines & cell-based medicines.