Tag: <span>transgene expression</span>

Expression vector and cell line engineering is the basis for expression and industrial production of biopharmaceuticals. The ultimate goal is to obtain clonal cell lines that secrete the protein of interest with high cell-specific productivity, and at consistently high levels over an extended number of cell generations, allowing for scale-up and cost-efficient large-scale manufacturing. Productivity and stability of expression are thus the prerequisites for developing commercially viable ­processes…

Manufacturing

Current in vivo gene therapy (GT) approaches are beginning to demonstrate significant clinical and safety limitations that may ultimately reduce their therapeutic utility. In particular, the potential for systemic toxicity due to the antigenicity of the gene transfer vector, the prospect of insertional mutagenesis/oncogenesis during gene transfer, and the possibility of germ line transfer of the transgene are issues raising concern. One promising alternative to gene therapy that mitigates these clinical and safety issues is gene-based cell therapy (GBCT), in which autologous cells are removed from a patient and modified ex vivo for a desired characteristic prior to reimplantation. By transferring the transgene ex vivo, many of the issues surrounding the in vivo use of the transfer vectors are reduced and issues surrounding germ line transfer can be practically eliminated…

Cell & Gene Therapy

The biopharmaceutical manufacturing sector is rapidly gearing up production capacity to satisfy the steadily escalating global demand for complex biologics to combat a number of treatable illnesses. Frequently, the biotherapeutics in demand are too complicated to be chemically synthesized and thus are beyond the reach of traditional pharmaceutical approaches. To effectively address this issue, these products must be developed and produced using viable and robust biological systems…

Biologics Production Manufacturing