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dc.rights.licenseAll rights reserveden_US
dc.contributor.advisorNieves Castro, Rafael A.
dc.contributor.authorNieves, William Loubriel
dc.date.accessioned2023-09-15T00:34:33Z
dc.date.available2023-09-15T00:34:33Z
dc.date.issued2023
dc.identifier.citationNieves, W. L. (2023). Improvement of Predictive Model to Reduce Impurity Presence Based on Raw Material Combination Pre-Selection [Unpublished manuscript]. Graduate School, Polytechnic University of Puerto Rico.en_US
dc.identifier.urihttp://hdl.handle.net/20.500.12475/1973
dc.descriptionDesign Project Article for the Graduate Programs at Polytechnic University of Puerto Ricoen_US
dc.description.abstractBiotechnology manufacture is composed of two main sections, Active Pharmaceutical Ingredient (API) and Drug Product (DP). The DS manufacturing most common steps are cell culture or fermentation (DSI), recovery and purification. The purification process purpose is to reduce impurities to acceptable levels. Depending on the purification raw materials, there will be different interactions with the DSI to be purified that could affect clearance capability. Multivariate analysis includes the effect of the considered variables and the response of interest. Therefore, it can be used to take into consideration combinations DSI solutions and purification raw materials available in inventory to predict the results of the impurity of interest. In this project, the improvement of a multivariate predictive model was performed by gathering recent manufacturing scale data and defining a more representative data set to improve the accuracy of the predictions. Upon implementation of the updated predictive model, several consecutive lots resulted in impurity results below the acceptable criteria. Key Terms - Bioprocessing, Biotechnology, Raw Materials, Prediction, Predictive Model, Purificationen_US
dc.language.isoenen_US
dc.publisherPolytechnic University of Puerto Ricoen_US
dc.relation.ispartofManufacturing Engineering;
dc.relation.ispartofseriesSpring-2023;
dc.relation.haspartSan Juanen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Researchen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Graduate students--Postersen_US
dc.subject.lcshPolytechnic University of Puerto Rico--Subject headings--Unassigneden_US
dc.titleImprovement of Predictive Model to Reduce Impurity Presence Based on Raw Material Combination Pre-Selectionen_US
dc.typeArticleen_US
dc.rights.holderPolytechnic University of Puerto Rico, Graduate Schoolen_US


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