Addressing Changes Associated with Technology Transfer: A Case Study

Abstract

REMICADE ® is a chimeric monoclonal antibody directed against TNF-α. It was the first drug product in the class of TNF-α inhibitors approved for use in humans. It is a lyophilized formulation of the drug substance, infliximab, and is approved for the treatments of autoimmune disorders including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, and psoriatic arthritis. Production of REMICADE was first approved in 1998 at Centocor’s Leiden, The Netherlands, facility. Soon after approval of the Leiden manufacturing facility, plans to scale-up and add a second manufacturing site in Malvern, Pennsylvania, were initiated. Comparability of the products prepared at the two facilities was demonstrated. The FDA approved the Malvern facility in April 2002. It was approved by the EMEA in 2003.