Physical Sciences Inc (PSI), in collaboration with the University of Massachusetts Lowell, has been awarded a program from the National Institutes of Health (NIH) to develop a novel biomanufacturing process analytical technology tool that enables in-line, continuous measurement of the metabolism of host cells in bioreactors for the large-scale manufacturing of therapeutic viral vectors.
Gene therapy uses genes to prevent and/or treat acquired disorders and inherited genetic diseases. Recently, the intensive investigation of human genes and related diseases has improved the capability of gene therapy as a promising future therapy that can significantly increase life expectancy for millions of patients suffering from incurable diseases. However, the clinical potential remains largely unleashed, mainly due to the limited biomanufacturing capacity of gene delivery products for clinical and commercial use. Manufacturing of gene therapeutic biologics involves harvesting viral vectors in mammalian cell cultures that are highly complex and difficult to control. The lack of understanding and control of the viral production processes has led to manufacturing challenges including low productivity, instability of cell lines, high levels of impurities, and difficult scalability with consistent product quality. Therefore, new biomanufacturing analytical technologies are critically needed to improve the understanding of the bioprocess dynamics and to support development of robust and efficient biomanufacturing processes.
PSI’s novel metabolic cytometry sensor probe measures the autofluorescence of intracellular metabolites to be used for real-time assessment of cellular-level redox metabolic state. An innovative spatially and temporally confined spectroscopy approach is used to efficiently differentiate fluorescence signals of intracellular metabolites from the nonspecific light background, achieving high specificity measurement of cellular physiology. Successful development of this technology will contribute to significant improvement in the understanding and control of bioprocesses for large-scale manufacturing of viral vector products for gene therapy.
For more information, contact:
Mr. William Kessler
Vice President, Applied Optics
Physical Sciences Inc.
Telephone: (978) 689-0003