Single Use Systems in Biologics Manufacturing and their Impact on Operational Technology

Since their inception in production, single use systems (SUS) have evolved and improved thanks to the continuous relationship between vendors and biopharmaceutical manufacturers, accommodating a wide range of operational needs. From culture initiation in small volume bags, to large-scale production bioreactors, chemical solution preparation and product storage, the implementation of single use technologies is a key initiative that many biopharmaceutical companies are undertaking. Scale-ability, flexibility, lower utility costs, reduced capital investment and reduced risk of contamination are the key advantages offered by disposable systems.
Regardless of the type of equipment utilized, the success of manufacturing operations largely depends on the adoption of efficient business process combined with the appropriate operational technology, mainly plant automation, Manufacturing Execution Systems (MES), planning and scheduling applications, and data analytics.
The adoption of single use systems dictates that organizations rethink their existing practices as well as the user requirement specifications (URS) of all electronic systems involved in the manufacturing process, enabling optimal execution and achieving additional benefits. Amongst the key areas that require close examination and redefinition are: scheduling of new process steps that result from inspection and assembly of SUS; automation recipes to allow for pauses and manual activities; configuration and maintenance of master data in the Enterprise Resource Planning (ERP) tools; material management in MES; definition of realistic models to estimate the potential contribution of Leachables and Extractables (L/E) substances.
 
Presented by Gloria Gadea-Lopez, Ph.D. of Shire
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.
 
 
John Maguire of Shire
John Maguire is the Associate Director of Manufacturing Systems at Shire’s Lexington, MA site. His main area of expertise is the application of process engineering and operational technology for life sciences. He has over 15 years of process engineering experience, including functional specification development and start-up of several drug substance manufacturing facilities in Ireland and the United States. John led the design and onboarding of single-use systems for Shire’s Lexington, MA manufacturing facility, which won an honorable mention for Facility of the Year in 2011. As a subject matter expert, John provides operations technology perspective for ERP and more recently to finite scheduling systems at Shire. John holds a Bachelor of Arts degree in Natural Science.
 
Mark Maselli of Shire
Mark Maselli is the Program Owner, responsible for the Single-Use System Lifecycle and is a Senior Engineer in the Business Operations Management group at Shire’s Lexington, MA site.  He has expertise in the design, development, and maintenance of single-use technologies, as an end-user in the biotechnology industry for over 5 years. Previously, he worked as a process engineer, specializing in single-use technologies, manufacturing operations, and polymer extrusion. He holds a Bachelor of Science in Chemical Engineering and a Master of Science in Engineering Management. His experience, single-use knowledge, and education, gives him a personal working knowledge of the application of single-use technologies in the biotechnology industry.
 
 
Sponsored by GE Healthcare

About GE Healthcare Life Sciences
The Life Sciences business of GE Healthcare provides a wide range of bioprocessing products and services that enable the development and manufacture of high-quality biotherapeutics and vaccines. Using our knowledge and expertise, we support our customers in increasing speed to market, while avoiding unnecessary costs and improving quality and performance in drug manufacturing.  As a provider of high-quality products, customized technical and commercial services, as well as design and construction of complete biomanufacturing solutions, we support the biopharmaceutical industry in making health visions a reality.
 
Presented by Ken Clapp, Senior Manager, Applications, Technology & Integration, GE Healthcare
Kenneth Clapp is a senior manager at GE Healthcare, focusing on applications, technology, and integration. Kenneth holds a Bachelor’s degree in biology with a specialization in subcellular biology. He received a Master’s degree in biological engineering, focused on biological control systems, mathematical modelling, and instrumentation. Early in his career, he worked as a cell culture technologist, produced antigens and antibodies in large scale, and developed hollow fiber-based bioreactors. Spanning four decades, Kenneth has worked in a variety of roles with bioprocess equipment manufacturers, including field service, sales and marketing, applied research and development, quality assurance, automation, and operations management. He has been managing bioprocessing equipment capital projects, including supply oversight, documentation and ERP integration.