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A Case Study on the Manufacture of Rituximab in the BTEC facility

Jane Winkleman, Sanaa Elouafiq, Renee Berry, Veronica Adams, Juan Cueva, Hope Metzler

Abstract

This case study used literature and professional experts to apply Quality by Design to the designing of a drug substance manufacturing operation for a rituximab biosimilar to be implemented in the BTEC facility. Rituximab is chimeric IgG1 kappa monoclonal antibody (mAb) used for the treatment of non-Hodgkin's lymphoma, rheumatoid arthritis and chronic lymphocytic leukemia. The drug substance final concentration will contain 25 mg BIOmAb (rituximab biosimilar) per milliliter.

Questions about BIOM degree

Biomanufacturing (BIOM) Master candidates will be available for questions about the new Professional Science Masters (PSM) after the seminar.