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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. [ABSTRACT FROM AUTHOR]

Optimization of cell culture and process parameters requires accurate assays for the quantification of the product. One of the most widely used techniques for measuring recombinant proteins is the ELISA assay in multiwell plates. Using grandfathers approved protocol, it yields valid results within one working day. Since the establishment of the widely accepted standard ELISA protocols, many factors have been improved: Better detection antibodies and more potent detection substrates are available, ELISA plates are made to strongly bind proteins, and most importantly, many steps can be automated. Computers are used for sophisticated data acquisition and handling. Below we outline how a combination of these parameters can be used to improve ELISA throughputs to a point where one person can handle over 800 samples per day with the high precision requested by the biopharmaceutical industry. [ABSTRACT FROM AUTHOR]

High Performance Membrane Affinity Chromatography (HPMAC) using Convective Interaction Media (CIM) disks has a high potential as fast multipurpose separation method in downstream processing and Quality Control of biopharmaceuticals [1,2]. Protein A, protein G and protein L have been immobilised on epoxy groups of poly(glycidyl methacrylate-co-ethylene dimethacrylate) macroporous disks (BIA, Slovenia) and used as affinity chromatographic stationary phases for the separation of human and bovine polyclonal and recombinant monoclonal IgGs. The specificity of the affinity ligands for antibodies (protein A and protein G for Fe fragments [3, 4] and protein L for kappa light chains [5]) allows isolation of IgGs, for example, from cell culture supernatants. [ABSTRACT FROM AUTHOR]