Abstract: The monitoring and control of bioprocesses is provided. More particularly, the present disclosure is directed to formulating buffer products from multiple buffer solutions for feeding the different operations occurring within a bioprocess line. As the buffer product is being formulated, the buffer product is tested for conductivity, refractive index, and optionally pH. The conductivity measurements are used in conjunction with refractive index measurements to ensure that the buffer product not only has the correct concentration of ions but also has the correct concentration of components. A controller can be used to make automatic adjustments to the buffer product should any of the measured parameters fall outside a preset range.

Abstract: The monitoring and control of bioprocesses is provided. The present disclosure provides the ability to generate generic calibration models, independent of cell line, using inline Raman probes to monitor changes in glucose, lactate, glutamate, ammonium, viable cell concentration (VCC), total cell concentration (TCC) and product concentration. Calibration models were developed from cell culture using two different CHOK1SV GS-KO™ cell lines producing different monoclonal antibodies (mAbs). Developed predictive models, qualified using an independent CHOK1SV GS-KO™ cell line not used in calibration, measured changes in glucose, lactate, ammonium, VCC, and TCC with minor prediction errors over the course of cell culture with minimal cell line dependence. The development of these generic models allows the application of spectroscopic PAT techniques in a clinical manufacturing environment, where processes are typically run once or twice in GMP manufacturing based on a common platform process.

Abstract: The monitoring and control of bioprocesses is provided. The present disclosure provides the ability to generate generic calibration models, independent of cell line, using inline Raman probes to monitor changes in glucose, lactate, glutamate, ammonium, viable cell concentration (VCC), total cell concentration (TCC) and product concentration. Calibration models were developed from cell culture using two different CHOK1SV GS-KO™ cell lines producing different monoclonal antibodies (mAbs). Developed predictive models, qualified using an independent CHOK1SV GS-KO™ cell line not used in calibration, measured changes in glucose, lactate, ammonium, VCC, and TCC with minor prediction errors over the course of cell culture with minimal cell line dependence. The development of these generic models allows the application of spectroscopic PAT techniques in a clinical manufacturing environment, where processes are typically run once or twice in GMP manufacturing based on a common platform process.

Abstract: The monitoring and control of bioprocesses is provided. More particularly, the present disclosure is directed to formulating buffer products from multiple buffer solutions for feeding the different operations occurring within a bioprocess line. As the buffer product is being formulated, the buffer product is tested for conductivity, refractive index, and optionally pH. The conductivity measurements are used in conjunction with refractive index measurements to ensure that the buffer product not only has the correct concentration of ions but also has the correct concentration of components. A controller can be used to make automatic adjustments to the buffer product should any of the measured parameters fall outside a preset range.

Abstract: Methods and devices for monitoring the viability of a biofilm comprising Pseudomonas aeruginosa bacteria by detecting pyocyanin are provided.

Abstract: Methods and devices for monitoring the viability of a biofilm comprising Pseudomonas Aeruginosa bacteria are provided by detecting pyocyanin. The invention relates to electrochemical methods and devices that offer a simple and inexpensive alternative for immediate identification of bacterial infection due to the presence of Pseudomonas aeruginosa. In some embodiments, an inexpensive, disposable electrochemical sensor can be used to rapidly screen for the presence of P. aeruginosa in clinical wound effluent samples.

Abstract: The monitoring and control of bioprocesses is provided. The present disclosure provides the ability to generate generic calibration models, independent of cell line, using inline Raman probes to monitor changes in glucose, lactate, glutamate, ammonium, viable cell concentration (VCC), total cell concentration (TCC) and product concentration. Calibration models were developed from cell culture using two different CHOK1SV GS-KO™ cell lines producing different monoclonal antibodies (mAbs). Developed predictive models, qualified using an independent CHOK1SV GS-KO™ cell line not used in calibration, measured changes in glucose, lactate, ammonium, VCC, and TCC with minor prediction errors over the course of cell culture with minimal cell line dependence. The development of these generic models allows the application of spectroscopic PAT techniques in a clinical manufacturing environment, where processes are typically run once or twice in GMP manufacturing based on a common platform process.

Abstract: Methods and devices for monitoring the viability of a biofilm comprising Pseudomonas Aeruginosa bacteria are provided by detecting pyocyanin. The invention relates to electrochemical methods and devices that offer a simple and inexpensive alternative for immediate identification of bacterial infection due to the presence of Pseudomonas aeruginosa. In some embodiments, an inexpensive, disposable electrochemical sensor can be used to rapidly screen for the presence of P. aeruginosa in clinical wound effluent samples.

Abstract: Devices for electrochemical measurement of a redox active substance secreted by a cell in a liquid sample are provided. The devices include one or more electrodes and a matrix capable of releasing a chemical agent that stimulates secretes of the redox active substance by the cell. In some embodiments, the devices include a nanofluidic electrode assembly in which the one or more electrodes are disposed within a nanofluidic channel. Methods of fabricating the devices and methods of using the devices to detect secretion of a redox active substance by a cell are also provided.

Abstract: Devices including an electrode assembly within a nanofluidic channel are provided for electrochemical measurement of the concentration of a redox active substance. Also provided are methods of fabricating the devices and methods of measuring a concentration of a redox active substance using the devices. The devices and methods, and sensors embodying them, provide fast and sensitive detection of the presence of a microorganism by detecting a redox active substance produced by the microorganism while preventing venting access of the microoganism itself to the electrode assembly.