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Evaluation of the Immuno-stimulatory Potential of Stopper Extractables and Leachables by Using Dendritic Cells as Readout by Robert Mueller; Anette Karle; Anne Vogt; Harald Kropshofer; Alfred Ross; Karsten Maeder; Hanns-Christian Mahler is a Chemistry article available to read on EtoBox.
What is Evaluation of the Immuno-stimulatory Potential of Stopper Extractables and Leachables by Using Dendritic Cells as Readout about?
Recombinant protein pharmaceuticals may bear some risks and undesirable side effects, such as the appearance of immunogenic reactions. The increased incidence of antibody-mediated pure red cell aplasia (PRCA) outside the United States after administration of a human serum albumin (HSA)-free EPREX (recombinant human erythropoietin alpha) formulation was explained with the generation of rubber stopper related leachables, possibly acting as immunogenic adjuvants. In our study, we have investigated the potential of extractable and leachable preparations of three different pharmaceutical relevant stoppers to generate a "danger signal" in a dendritic cell assay. Furthermore, the investigated extractable and leachable preparations were characterized by NMR and a micelle-based polysorbate quantification method. In summary, we could demonstrate that stopper extractables, either generated by extraction or by leaching conditions, were not acting as danger signals for dendritic cells. Instead we identified degradation products of polysorbate 80, oleic acid and follow-up products, occur only under very accelerated conditions (100 degrees C for 4 days) as a potential stimulator for these immune
Who reads Evaluation of the Immuno-stimulatory Potential of Stopper Extractables and Leachables by Using Dendritic Cells as Readout?
It is typically read by researchers, students, and practitioners in Chemistry.
- Author
- Robert Mueller; Anette Karle; Anne Vogt; Harald Kropshofer; Alfred Ross; Karsten Maeder; Hanns-Christian Mahler
- Publisher
- John Wiley and Sons; Elsevier ; Elsevier Inc.; Elsevier BV (ISSN 0022-3549)
- Published
- 2009
- Language
- EN
- Field
- Chemistry (Physical Sciences)