Genzyme is committed to discovering and delivering transformative therapies for patients with rare and special unmet medical needs, providing hope where there was none before. With specialized facilities located around the world, Genzyme has particular expertise in manufacturing complex biological medicines. In 2013, Genzyme implemented the Review-By-Exception (RBE) program: 1) a 33% increase in capacity, and 2) shortened turnaround to meet bulk intermediate product release timelines. The primary objective of the RBE program was to reduce manual reviews of batch records by Manufacturing and QA personnel. This was achieved by integrating the Manufacturing Execution System (MES) and DeltaV Distributed Control System (DCS) with the PI System.
The automatic transfer of data from PI Server to MES allowed the batch records to be configured for Review-By-Exception. As a result, the only entries that require review are manual data entries for critical parameters and flagged event log entries. The automatic transfer of data from the PI System greatly reduced the number of manual data entries required in the batch records. Since 2014, there have been 28,000+ batch records completed and over 24,000 of these have been automatically reviewed by the system. Since system-reviewed records do not require manual reviews by Manufacturing and QA personnel, this has resulted in savings of over 11,000 man-hours. Secondary benefits realized include time savings in batch record execution, improvements in right-first-time performance of batch record reviews, reduction in non-value added paperwork and associated documentation errors, and reduction in deviations.
Ryan Greeley is the Lead Automation Engineer for Genzyme’s Fabrazyme manufacturing facilities in Framingham, MA. He has been at Genzyme for 5 years, providing automation support for the commercial manufacturing and the on-going expansion and continuous improvement projects related to the DCS, PLC, Historian, and MES systems. Ryan is currently pursuing his MBA part-time at Boston University’s Questrom School of Business. Mr. Greeley holds a B.S. and M.S. in Chemical Engineering, with a focus in Biochemical Engineering, from Villanova University.