The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.

The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.

Methods of standardizing a fermentation process may include obtaining a fluidic sample, measuring one or more physical parameters of the sample, comparing the measurement of the physical parameter of the material to a baseline value of the physical parameter for the fermentation process, and responsive to a deviation of the measurement of the physical parameter from the baseline value, determining a remediation action based on a correlation between the physical parameter and regulatory genes of a fermentation organism.

The present invention relates to a device and processes for producing liquid media for cell cultures, whereby the liquid media are produced automatically by dissolving ingredients in water. The present invention also relates to a device for producing media used in cell cultures or a substance produced by cell cultures using a bioreactor process.

Clean-in-place methods applicable to improve production of fermentation operations are disclosed herein to monitor, report, and control the cleaning reagents applied, residual components thereof, and clean-in-place conditions within levels that are compatible with fermentation processes, without limiting the effectiveness of the clean-in-place protocol with respect to cleaning or sanitizing the fermentation system.

Generation of bubbles in an organic-substance production apparatus is suppressed. A gas treatment method including: an adsorption step of passing a source gas containing at least carbon dioxide and nitrogen through an adsorption unit for adsorbing carbon dioxide to reduce a carbon dioxide concentration in the source gas; a supply step of supplying the source gas whose carbon dioxide concentration has been reduced by the adsorption step to an organic-substance production apparatus; and a monitoring step of monitoring a carbon dioxide concentration and a nitrogen concentration in the source gas; wherein the adsorption step has an ability regulation step of enhancing an ability of the adsorption unit to reduce a carbon dioxide concentration in the source gas, when a total concentration of the carbon dioxide concentration and the nitrogen concentration monitored in the monitoring step exceeds a threshold value.

The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.

A predictive model is described that can predict parameter concentrations in the future based on initial, measured concentrations and historical data. A plurality of multivariate techniques can be used to construct the predictive model capable of forecasting concentrations over multiple and diverse cell lines. The predictive model is also scalable. In one embodiment, a future lactate concentration trajectory is determined and at least one condition within a bioreactor is changed or modified to maintain lactate concentration within desired ranges.

Methods and systems for measuring viability and function of islet cells or stem cell-derived beta cells in an implantable device featuring setting the temperature of the cells in the implantable device to a low temperature to reduce metabolic levels of the cells and reduce oxygen requirements of the cells, and measuring oxygen consumption rates. An oxygen sensor at the inlet of the implantable device and an oxygen sensor at the outlet of the implantable device are used to calculate oxygen consumption rates of the cells, which in turn are indicative of viability. The reduction in temperature can also be used for loading cells into the implantable devices to help reduce ischemic and/or physical injury. The present invention may be used with other cell types, e.g. hepatocytes, heart cells, muscle cells, etc.

Disclosed herein are devices, methods and compositions for making and using microfluidic devices comprising making a microfluid device comprising one or more channels; and coating at least a portion of an interior surface of at least one channel, wherein one or more gradients are formed by simultaneously introducing into the device a first cellular culture media composition having a certain concentration of a gas, an active agent or both and a second composition having a concentration of a gas, an active agent or both that is/are different from that of the first composition. Such devices are used to investigate cellular responses to physiological states and active agents.