Addressing Changes Associated with Technology Transfer: A Case Study

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.