System and Method for Regulating Cell Culture Based Production of Biologics

摘要

The disclosure is directed to a system and method for control of at least one bioreactor, other cell cultivation-related equipment, and systems containing any combination of these in a plant. For example, a Plant-Wide Control System (PWCS) or a Process Control System (PCS) may be divided into three main components: hardware (including operating systems, such as a controller communicating with one or more servers of a network associated with the PWCS, (2) software (such as a control module) for performing control, and (3) one or more instrument control loops, which may be used by the software to maintain certain process values. Moreover, a Height Equivalent of a Theoretical Plate (HETP) value and an asymmetry factor may be determined based on real-time analysis on a chromatography column, using PWCS components.

主权项

1. A system for performing real-time analysis on a chromatography column comprising:
a chromatography column; a conductivity meter; and at least one processor for executing stored program instructions to:
measure one or more conductivity values of the chromatography column using the conductivity meter,determine a baseline conductivity value by recording a predetermined number of conductivity values from a first column volume to a second column volume and calculating an average of the predetermined number of conductivity values, wherein the baseline conductivity value is the calculated average,determine whether a first measured conductivity value is less than a maximum conductivity value and is greater than a 10% peak falling value, and based on the determination, record a time and a column volume corresponding to the first measured conductivity,determine whether a second measured conductivity value is less than the maximum conductivity value and is greater than a 50% peak falling value, and based on the determination, record a time and a column volume corresponding to the second measured conductivity,detect whether 10% falling of conductivity is reached, andbased on the detection, calculate one or more of: (i) a time-based asymmetry factor and (ii) a volume-based asymmetry factor or calculate one or more of: (i) a time-based Height Equivalent of a Theoretical Plate (HETP) value and (ii) a volume-based HETP value based at least in part on the baseline conductivity value, the times and column volumes of the first measured conductivity and the second measured conductivity, and the maximum conductivity value.