Multivariate process chart to control a process to produce a chemical, pharmaceutical, biopharmaceutical and/or biological product

A computer-implemented method for determining a multivariate process chart, the multivariate process chart to be used to control a process to produce a chemical, pharmaceutical, biopharmaceutical and/or biological product, the multivariate process chart including a first trajectory, an upper limit for the first trajectory and a lower limit for the first trajectory, the method comprising:

• providing a plurality of first-scale vessels, each of the first-scale vessels containing fluid for producing the product;
• receiving, by a first process control device, process parameters, the process parameters including process parameters to be controlled and process parameters to be measured;
• controlling, by the first process control device and at least partly in parallel, the process in each of the first-scale vessels, wherein the first process control device is in continuous operation in order to control each of the first-scale vessels;
• periodically determining, at least in part by the first process control device, process parameter values for the process parameters from the fluid ineach of the first-scale vessels;
• defining groups of the process parameter values according to a common characteristic, wherein each of the groups includes process parameter values determined from multiple ones of the first-scale vessels, wherein the groups of process parameter values are defined according to the times at which the process parameter values were determined;
• determining at least one statistically representative value for each of the groups of process parameter values, such that each of the groups of the process parameter values has a different corresponding statistically representative value;
• establishing the first trajectory from the statistically representative values;
• and
• determining the upper limit and the lower limit based on a measure of variation within each group,
• wherein the method further includes selectively excluding process parameter values determined from respective ones of the first-scale vessels in order to identify remaining process parameter values, wherein the groups of the process parameter values consist of the remaining process parameter values, and
• wherein the remaining process parameter values are identified when at least one of the following criteria applies:
• i. process parameter values determined from one of the respective ones of the first-scale vessels are identified as outliers in comparison to process parameter values determined from the other first-scale vessels,
• ii. at least one of the process parameters is identified as a critical process parameter, and values of the critical process parameter determined from one of the respective ones of the first-scale vessels are outside an accepted range,
• iii. process output values determined from one of the respective ones of the first-scale vessels are outside an accepted range;
• iv. a predicted first trajectory for one of the respective ones of the first-scale vessels is more than a specified distance from a golden batch trajectory for the first-scale vessels or a nearest neighbor of the respective one of the first-scale vessels;
• and
• v. a multivariate score for one of the respective ones of the first-scale vessels is outside an accepted range or more than a specified distance from the golden batch trajectory, wherein the multivariate score is derived from process parameter values and/or process output values of the respective one of the first-scale vessels.