The SPP Biotech Module 1: Proteins for Medical Applications a Multidisciplinary Effort for the Development of a Recombinant Anti-RhD Antibody Preparation of Hemolytic Disease of the Newborn

Hemolytic Disease of the Newborn (HDN) can be a life threatening condition in Rh D positive babies born from Rh D negative mothers. For several decades, prophylactic treatment with immunoglobulins derived from human blood plasma from immunized donors has been available. Because of concerns for donor safety and limited supply of raw material, alternatives for production of specific immunoglobulins were investigated. Since 1994 ZLB has, in collaboration with a group at the University Hospital in Bern, started to develop recombinant anti-D antibodies. In 1997, a multidisciplinary team with expertise ranging from molecular biology to biochemical engineering for large scale operations was constituted, co-funded by the Swiss National Science Foundation and ZLB, as the industrial partner. The aims of this team are to establish the prophylactic principle and the manufacturing process for anti-D therapy based on recombinant antibody preparations produced from Chinese hamster ovary (CHO) cells.