Abstract: Improved methods for large scale production of proteins and/or polypeptides in cell culture is provided. In accordance with the present invention, the method provides for culturing cells that have metabolically shifted. The use of such a method or system allows high levels of protein or polypeptide production and reduces accumulation of unwanted metabolic waste such as lactate. Proteins and polypeptides expressed in accordance with the present invention may be advantageously used in the preparation of pharmaceutical, immunogenic, or other commercial biologic compositions, such as antibodies.

Abstract: Improved methods for large scale production of proteins and/or polypeptides in cell culture is provided. In accordance with the present invention, the method provides for culturing cells that have metabolically shifted. The use of such a method or system allows high levels of protein or polypeptide production and reduces accumulation of unwanted metabolic waste such as lactate. Proteins and polypeptides expressed in accordance with the present invention may be advantageously used in the preparation of pharmaceutical, immunogenic, or other commercial biologic compositions, such as antibodies.

Abstract: A system and method for auto-inoculating a bioreactor in a seed train process includes an expansion chamber for expanding an initial cell stock to a viable cell density, a bioreactor for inoculation with the expanded cell stock; a fluid communication path between the expansion chamber and the bioreactor; a pump for controlling fluid flow through the fluid communication path; a Raman spectrometer for generating Raman spectral data; a multivariate model providing predictions of processing variables in the expansion chamber; and a computer system for controlling the pump to effect auto-inoculation of the bioreactor from the expansion chamber, through the fluid communication path, when the computer system determines from the Raman spectral data that one or more predefined trigger events have occurred.

Abstract: The present invention provides in situ Raman spectroscopy methods and systems for monitoring and controlling one or more process variables in a bioreactor cell culture in order to improve product quality and consistency. The methods and systems utilize in situ Raman spectroscopy and chemometric modeling techniques for real-time assessments of cell cultures, combined with signal processing techniques, for precise continuous feedback and model predictive control of cell culture process variables. Through the use of real-time data from Raman spectroscopy, the process variables within the cell culture may be continuously or intermittently monitored and automated feedback controllers maintain the process variables at predetermined set points or maintain a specific feeding protocol that delivers variable amounts of agents to the bioreactor to maximize bioproduct quality.

Abstract: Improved methods for large scale production of proteins and/or polypeptides in cell culture is provided. In accordance with the present invention, the method provides for culturing cells that have metabolically shifted. The use of such a method or system allows high levels of protein or polypeptide production and reduces accumulation of unwanted metabolic waste such as lactate. Proteins and polypeptides expressed in accordance with the present invention may be advantageously used in the preparation of pharmaceutical, immunogenic, or other commercial biologic compositions, such as antibodies.

Abstract: Improved methods for large scale production of proteins and/or polypeptides in cell culture is provided. In accordance with the present invention, the method provides for culturing cells that have metabolically shifted. The use of such a method or system allows high levels of protein or polypeptide production and reduces accumulation of unwanted metabolic waste such as lactate. Proteins and polypeptides expressed in accordance with the present invention may be advantageously used in the preparation of pharmaceutical, immunogenic, or other commercial biologic compositions, such as antibodies.