LumaCyte's Radiance instrument can be used for monitoring of biological production systems. Either in an at-line (periodic sampling) or in-line (continuous monitoring) configuration, Radiance can monitor mammalian, insect, yeast or other cells for production parameters. Many methods for biologics manufacturing use viruses and cell lines to produce the therapeutic or vaccine. Radiance can quickly and cost effectively detect viral infection during these processes, making it invaluable for process optimization and scale-up. This broad applicability stems from the ability to rapidly detect viral infection or cellular changes in a variety of cell types. Changes in cellular morphology, biochemistry (compositional changes in the cytoplasm, for example), or development of viral inclusion bodies in infected cells give rise to measurable differences in cells. This capability gives Radiance the distinct advantage over other detection technologies of being useable in-line for real-time process monitoring.
Mammalian cells grown in a bioreactor connected directly to Radiance monitoring infectivity during the production of a vaccine. Current concept of operations.
Adventitious virus detection
The detection of virus in biologic drug manufacturing facilities and the resulting drug preparations is of critical importance. Patient safety is the first and most pressing concern, but also the economics of production management. A facility closure for bioremediation of viral contaminants represents an enormous cost both in terms of lost product sales, and time, personnel, and materials lost due to the contamination.
LumaCyte's Radiance instrument can monitor mammalian cell production for the presence of adventitious agents by measuring multiple parameters simultaneously. It allows for rapid detection of changes in the producing cell population that may indicate health or decline due to biological or chemical contamination. The presence of unwanted viruses can hamper or spoil the production process, so the rapid, automated monitoring of changes within susceptible cell lines is critical for detection of adventitious agents. Since the Radiance platform does not rely on antibodies, primers, or other prior knowledge, it allows the detection of previously unknown threat agents that can ruin the production process, spoil the product, or harm patients.