The BioPharmaceutical manufacturing industry is experiencing an inflection point. Competition, price controls, globalization, biosimilars, and technology shifts have resulted in a new approach to building and operating manufacturing facilities. Amgen is on the leading edge of this change, building new more flexible facilities and retrofitting existing plants to be more efficient. The result is a highly automated shop floor with integrated systems that are both faster to startup and require fewer ongoing resources to maintain. In order to achieve these goals, Amgen is identifying a standard IT architecture and integration approach between MES, DeltaV, OSIsoft, and other systems to streamline the flow of manufacturing data in support Electronic Batch records and continued process improvement. This presentation will discuss this architecture and the benefits of this approach over traditional IT deployment models previously leveraged at Amgen plants.
Marc Puich is Sr. Vice President, Sales and Program Management at Werum, where he has focused on managing the Western US Region for the company since January, 2008. He is directly involved with implementations of Werum’s PAS-X MES product at customer sites, as well as supporting organizations as they maximize its benefits. Puich came to Werum with ten years consulting experience as a partner focused on the pharmaceutical and biotech sectors. He holds a Bachelor’s in Physics from UC Berkeley and Master’s degree in Industrial Engineering and Engineering Management from Stanford University