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.

Sensors are configured to capture measurement data representing dissolved oxygen (DO) measurements of an environment and capacitance measurements of a medium of the environment. A memory includes computer-executable instructions. One or more processors are communicatively coupled to the one or more sensors and configured to execute the computer-executable instructions to carry out operations comprising: generating, using first measurement data captured by the one or more sensors, a model based on a relationship between the first set of DO measurements and the first set of capacitance measurements; receiving, from the one or more sensors, second measurement data; predicting, using the model and based on the new capacitance measurement, an expected DO measurement; determining whether to use the expected DO measurement or the new DO measurement; and controlling, a valve to cause the determined oxygen input amount to flow into the environment based on the expected DO measurement.

The present invention is a manufacturing method for producing fermentation products using a fermentation vessel, including steps of: preparing a fermentation vessel and a sensor, introducing liquid into the fermentation vessel, and operating the fermentation vessel in which properties of liquid in the fermentation vessel are measured to adjust operating conditions; wherein the sensor device has a sensor for measuring liquid properties and a sensor cover body; a bottom permeable portion for passing liquid and crystals in the liquid is disposed on the bottom surface of the cover body, and a top permeable portion for passing liquid and crystals in the liquid is disposed on the top surface of the cover body; micropores are respectively formed in the bottom permeable portion and the top permeable portion; and micropores disposed in the top permeable portion are the same or larger than micropores disposed in the top permeable portion.

In a culturing method, microalgae are cultured in a culturing solution while a gas containing carbon dioxide is supplied to the culturing solution. In an ion concentration acquisition step, an acquired value of a concentration of hydrogen carbonate ions in the culturing solution is obtained. In an ion concentration adjustment step, in the case that the acquired value does not reside within a set concentration range that is set beforehand, at least one of a temperature or a pH of the culturing solution is adjusted, whereby the concentration of hydrogen carbonate ions in the culturing solution is adjusted to reside within the set concentration range.

The present invention provides a buffer preparation and transfer system for a process of manufacturing an antibody pharmaceutical which can reduce the input of a lot of labor due to the preparation of each buffer, including the weighing of a buffer chemical, the input of a powder, stirring and transfer, and significantly shorten process time by positioning and designing components in a manner that automates the preparation and transfer of various buffer solutions using a control unit and controls the concentration and composition of a buffer by transferring a concentrated component solution into the buffer storage tank using an opening/closing valve and a flow rate-adjusting valve, and unlike the related art, reduces the number of buffer preparation tanks corresponding to individual buffer storage tanks, which is advantageous for securing a safe distance between processes and securing a facility area.

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.

The present disclosure relates to a scalable experimental workflow that uses a culture system to maintain a steady state in a biological system, and techniques for identifying values for parameters in a in silico model based on experimental data obtained from the biological system. Particularly, aspects of the present disclosure are directed to obtaining measurement data for one or more characteristics of a biological system developed in a culture system, where the measurement data is indicative of each of the one or more characteristics at a physiological steady state where growth of the biological system is occurring at a substantially constant growth rate, determining a value for a parameter of a model of the biological system based on an growth formula, the measurement data, and the substantially constant growth rate, and parametrizing the model with at least the value determined for the parameter.

Algae harvesting and cultivating systems and methods for producing high concentrations of algae product with minimal energy. In an embodiment, a dead-end filtration system and method includes at least one tank and a plurality hollow fiber membranes positioned in the at least one tank. An algae medium is pulled through the hollow fiber membranes such that a retentate and a permeate are produced.

The present disclosure relates to a cell culture apparatus, methods for cell cultivation by using the cell culture apparatus, and a cell culture incubator comprising the cell culture apparatus. The cell culture apparatus comprises a plurality of cell culture modules arranged adjacent to each other. Each cell culture module comprises two or more culture medium reservoirs connected by two or more flow channels. The flow channels go through a basal chamber arranged under an apical chamber. The apical and basal chambers are separated by a porous membrane. The bottom part of the at least two culture medium reservoirs comprise a holding member configured to be compatible with a liquid handling system. The basal chamber has a bottom part arranged higher than a bottom part of each of the culture medium reservoirs. The cell culture apparatus further comprises a cavity under the bottom part of the basal chamber.

Provided herein are systems, devices and methods to automate and optimize the decellularization process of representative tissues, such as soft tissues, for extracellular matrix (ECM)-based scaffold and biomaterial production. The automated decellularization processes and devices significantly reduce the exposure time to reagents, minimize lot-to-lot variability, and largely preserve the native composition of the ECM from the decellularized tissue or species.