Shire is the 2018 ISPE Facility of the Year Category Winner for Operational Excellence for their project – Los Angeles Quality Control Laboratory in Los Angeles, California.
Projects selected for recognition in the Operational Excellence category exemplify the application of principles, systems, and tools of continuous improvement aimed at improving operational efficiency, delivery, quality, product yield, consistency, a culture of continuous improvement behaviors, and cost of goods. Additionally, these principles, systems and tools ensure business continuity through stable supply environment, health and safety, and customer satisfaction from existing or new facilities, processes, and manufacturing operations. Use of a scorecard or other reports are encouraged to identify key performance metrics of operational excellence and demonstrate improvement.
Shire, the leading global technology company, has the unwavering goal of improving and sustaining lives of patients suffering with rare diseases and other highly specialized conditions. Shire’s global reach of more than 24,000 employees in more than 65 countries allows Shire to distribute therapies to patients in over 100 countries worldwide.
Every year, millions of patients depend upon plasma-derived therapies obtained through plasma fractionation processes. These processes isolate essential lifesaving proteins found in human plasma and are used to treat patients living with immunodeficiency diseases and other disorders. Plasma can be used to develop a myriad of treatments from immune globulins (a concentration of all antibodies found in human plasma) used to treat patients suffering from autoimmune disorders, to albumin used as a volume expander to treat shock and trauma victims.
Shire’s Los Angeles Facility is one of the largest plasma fractionation sites in the world network and is globally licensed in the United States, China, and the European Union markets. At the site, human plasma is fractionated, purified, and formulated into intermediates and bulk drug substances to treat patients living with Primary Immunodeficiency, Hemophilia A, Fluid Imbalance, Emphysema, and Infant Botulism. The need to ensure quality controls throughout the manufacturing process is critical to the manufacturing of these rare disease products. As such, Shire invested the capital resources to build a state-of-the-art Quality Control Laboratory to ensure quality products and to meet the increased global demands for plasma derived therapies.
Shire’s new 16,000-square-foot Quality Control Laboratory at the Los Angeles, California, Manufacturing Facility is a key element of Shire’s strategy to ensure a better, faster, and more economical delivery to patients worldwide. The planning process and resulting solutions for this “next generation” QC lab reflect Shire’s commitment to not only improve the efficiency of their operation, but to give special attention to the effectiveness and well-being of a dedicated group of people who are tasked with delivering therapies that enable people with life-altering conditions to lead better lives.
ISPE congratulates the Shire QC Lab team for their achievements and their FOYA award winning entry for Operational Excellence. Learn more about the 2108 FOYA Operational Excellence Category winner.