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.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Acknowledgments.
The authors gratefully acknowledge Larry Doolittle, Paul Gahr, and Karen Fixler for their contributions to the project and Timothy Laverty for useful discussions.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2010 American Association of Pharmaceutical Scientists
About this chapter
Cite this chapter
Myers, M.M., Keating, C., Bannon, J., Neblock, D.S., Wojciechowski, P.W. (2010). Addressing Changes Associated with Technology Transfer: A Case Study. In: Shire, S., Gombotz, W., Bechtold-Peters, K., Andya, J. (eds) Current Trends in Monoclonal Antibody Development and Manufacturing. Biotechnology: Pharmaceutical Aspects, vol XI. Springer, New York, NY. https://doi.org/10.1007/978-0-387-76643-0_6
Download citation
DOI: https://doi.org/10.1007/978-0-387-76643-0_6
Published:
Publisher Name: Springer, New York, NY
Print ISBN: 978-0-387-76642-3
Online ISBN: 978-0-387-76643-0
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)