Abstract: In an aspect, there is provided a computer-implemented method for approximating product production in a bioreactor. The method comprises: providing a bioreactor containing live cells in a substrate, the bioreactor for cultivating, over a time period, a product derived from or of the cells during a manufacturing process; providing two or more sensors for measuring respective two or more different physical attributes of the substrate during the time period; receiving, at a processor, sensor data from the two or more sensors; and determining via the processor, based on a predetermined or recursive algorithm that correlates the sensor data and the product production by independent consideration of the sensor data of the two or more different physical attributes or by multivariate consideration of the sensor data of the two or more different physical attributes, an approximate amount of the product.

Abstract: A method for monitoring and recording a process in a clean space and a system for implementing same are provided. The method involves providing an electronic process record to a user using at least one processor; monitoring, using at least one sensor, for an event associated with the electronic process record; detecting, using the at least one sensor, the event associated with the electronic process record; recording in at least one data storage, using the at least one processor, information associated with the detected event, the recorded information being associated with a record of the electronic process record in the at least one data storage; verifying, using the at least one processor in communication with the at least one data storage, the recorded information; and storing in the at least one data storage, using the at least one processor, an indication that the recorded information has been verified.

Abstract: Described here are systems and methods for a reusable, aseptic connector. A connector system provides aseptic fluid connection. The connector system has an inlet connector assembly having an inlet fluid passageway and an inlet valve configured to seal the inlet fluid passageway when in a disconnected state. The connector also has an outlet connector assembly having an outlet fluid passageway and an outlet valve configured to seal the outlet fluid passageway when in a disconnected state. The inlet valve is configured to couple to the outlet valve to form an aseptic fluid connection between the inlet and outlet fluid passageways when in a connected state.

Abstract: A method for monitoring and recording a process in a clean space and a system for implementing same are provided. The method involves providing an electronic process record to a user using at least one processor; monitoring, using at least one sensor, for an event associated with the electronic process record; detecting, using the at least one sensor, the event associated with the electronic process record; recording in at least one data storage, using the at least one processor, information associated with the detected event, the recorded information being associated with a record of the electronic process record in the at least one data storage; verifying, using the at least one processor in communication with the at least one data storage, the recorded information; and storing in the at least one data storage, using the at least one processor, an indication that the recorded information has been verified.