Enabling comprehensive data analytics and process monitoring in Biomanufacturing – Key success factors, methodologies and practical insights that lead to a successful implementation

17th January 2018 | 10AM EST | Robert Dimitri, Hugo Guerra and Gloria Gadea-Lopez, Ph. D |WATCH FOR FREE

Technical teams rely on the availability of meaningful data and effective tools to perform process monitoring, to conduct root cause analysis and investigations and, most of all,  to obtain new insights into their operations.  In this article, the authors discuss the implementation and management of a comprehensive system for data analytics at Shire Lexington, MA site, the lessons learned, and practical advice towards the successful deployment of these key applications.


Presented by Robert Dimitri, Hugo Guerra and Gloria Gadea-Lopez, Ph. D

Gloria Gadea-Lopez, Ph.D. is Director of Business Operations Management at the Shire Lexington, MA manufacturing site. She has over 15 years of experience implementing electronic applications for biopharmaceutical manufacturing and their associated compliance practices. She has led the deployment of integrated tools for data analytics, Manufacturing Execution Systems (MES), historians, machine vision and more recently, finite scheduling. She holds degrees in Chemical Engineering (BS), Food Science (MS) and a Ph.D. in Biosystems Engineering.  Her team is responsible for business operations analysis and operations technology for the Lexington MA Biologics site. Of particular interest is the impact of single use systems (disposables) on MES, automation and data analytics.



Robert Dimitri is an Associate Director in the Production and Business Systems group at Shire leading a team for the implementation of electronic applications used for the analysis of internal manufacturing operations data, used to support the production of biologic drugs to treat rare diseases. He has over 14 years of experience in this field, having worked previously as a process engineer and developing software to perform process data analytics. Robert has a B.S. degree in Chemistry and Computer Science, an M.S. in Computer Science, and an M.B.A.



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