2016 - Users Conference - San Francisco - Life Sciences, Food and Beverage, Specialty Chemicals
A Knowledge Management Model for Pharmaceutical Development
Founded 30 years ago, Shire is a leading biopharmaceutical company with a focus on rare diseases and other specialty conditions with operational headquarters in Lexington, Massachusetts and Zug, Switzerland. In the pharmaceutical development space, data not only defines products – it is the product. This presentation will give an overview of Shire Pilot Plant Operations, applications of VM architecture, and the use of the PI System as a data integrity tool for increasing researcher productivity. It will also explore a case study from Shire where a number of OSIsoft PI System applications, including Asset Framework, Event Frames, PI Coresight, PI WebParts and Notifications, have been implemented to improve knowledge management in a perfusion cell culture process development environment. Challenges addressed include managing diverse data sources, islands of equipment and instruments, user adaptation to change, and consolidation of multiple network architectures into one secure network for R&D.
Paul Turvey is currently the Associate Director of Shire Laboratory Operations in Lexington, Massachusetts where he leads a group responsible for laboratory infrastructure planning, system lifecycle management and materials procurement. He is a professional engineer and PMP with 15 years of experience in small molecule pharmaceutical and biotechnology operations. He has held roles of increasing responsibility in engineering, manufacturing and process development at Apotex, Genentech and Shire. Career highlights include startup of a greenfield 8-reactor API plant, doubling of success rate at a 200KL mammalian cell culture facility, and startup of a state-of-the-art fill-finish facility. Paul holds a bachelor’s degree in chemical engineering from McGill University in Montreal as well as an MBA and an MS in Biotechnology Management from the University of Maryland – University College.
Brad Ebel is the Manager of Upstream and Media Production in Shire’s Pilot Plant Operation (PPO) Group and has been active in the biopharmaceutical industry for over 15 years. For over 12 years, he has focused on the disposable industry. While at Shire, he has designed and developed two fully disposable perfusion-based cell culture operation facilities that are responsible for supporting process development activities and supplying material for toxicology studies. Before working at Shire, Brad worked for two different GMP manufacturing companies in Colorado where he held roles in process development, MFG operation and media production groups. While in Colorado he helped developed and commission a stainless steel MFG/PD lab from “dirt” to operation in 6 months. In addition, at a separate company, he was able to develop a MFG process in an ISO 7 (100ft2) laboratory and later scaled the process to an ISO5-8 (7200+ft2) dual facility that he helped design, oversaw the construction of, and was partly responsible for commissioning it into a cGMP facility. Brad holds a B.S. in Chemistry from Westminster College.