MULTIVARIATE BRACKETING APPROACH FOR STERILE FILTER VALIDATION

摘要

A method of reducing resource utilization for sterile filter validation includes obtaining historical datasets that each include respective values of a plurality of parameters associated with a respective sterile filtration process for a respective protein molecule, and generating, by processing the plurality of historical datasets, a PCA model. Vectors of the PCA model correspond to differently weighted combinations of the plurality of parameters, and collectively define a model space. The method also includes obtaining a target dataset that corresponds to a sterile filtration process for a target protein molecule, and includes target values of the plurality of parameters. The method also includes mapping the target values onto the model space, determining whether the mapped target values fall within a normal operating region of the model and error space, and causing sterile filter validation to be selectively bypassed or not bypassed accordingly.