Advanced data-driven modeling for purification process in biopharmaceutical manufacturing

A system for assessing performance of an instance of a chemical process having a series of consecutive phases, comprising:

• one or more processors;
• a
• memory;
• and
• one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors, the one or more programs including instructions for:
• obtaining data related to the instance of the chemical process;
• and
• evaluating, based on the data related to the instance of the chemical process, the performance of the instance of the chemical process using a plurality of performance thresholds,
• wherein the plurality of performance thresholds is obtained by training a hierarchical model based on one or more historical instances of the chemical process, and
• wherein the hierarchical model comprises:
• a plurality of batch-evolution models (BEMs) at a first level of a hierarchy, each BEM model corresponding to one phase of the series of consecutive phases;
• a plurality of batch-level models (BLMs) at a second level above the first level of the hierarchy, each BLM model corresponding to one phase of the series of consecutive phases;
• an overall performance model at a third level at a third level above the second level of the hierarchy, the overall performance model corresponding to all of the series of consecutive phases.

A non-transitory computer-readable storage medium storing one or more programs for assessing performance of an instance of a chemical process having a series of consecutive phases, the one or more programs comprising instructions, which when executed by one or more processors of an electronic device, cause the electronic device to:

• obtain data related to the instance of the chemical process;
• and
• evaluate, based on the data related to the instance of the chemical process, the performance of the instance of the chemical process using a plurality of performance thresholds,
• wherein the plurality of performance thresholds is obtained by training a hierarchical model based on one or more historical instances of the chemical process, and
• wherein the hierarchical model comprises:
• a plurality of batch-evolution models (BEMs) at a first level of a hierarchy, each BEM model corresponding to one phase of the series of consecutive phases;
• a plurality of batch-level models (BLMs) at a second level above the first level of the hierarchy, each BLM model corresponding to one phase of the series of consecutive phases;
• an overall performance model at a third level at a third level above the second level of the hierarchy, the overall performance model corresponding to all of the series of consecutive phases.