2006
DOI: 10.1016/j.intimp.2005.10.001
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An in vivo model to assess factors that may stimulate the generation of an immune reaction to erythropoietin

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Cited by 37 publications
(22 citation statements)
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“…Immunogenicity is a significant problem associated with protein therapeutics [60,61]. Due to artificial production processes, recombinant therapeutics are often not completely identical to their human native counterparts.…”
Section: Monitoring Antigenicity Of Therapeutic Drugsmentioning
confidence: 99%
“…Immunogenicity is a significant problem associated with protein therapeutics [60,61]. Due to artificial production processes, recombinant therapeutics are often not completely identical to their human native counterparts.…”
Section: Monitoring Antigenicity Of Therapeutic Drugsmentioning
confidence: 99%
“…Between 1998 and 2000, nearly 200 cases of epoetin-associated PRCA cases were reported (21). Most cases occurred outside the United States and were attributed to the substitution of Tween in place of human serum albumin as a stabilizer for epoetin (22)(23)(24). The interaction of Tween with the uncoated rubber in prefilled syringes seems to cause leachates.…”
Section: Esa-induced Prcamentioning
confidence: 99%
“…1 Intensive analytical characterization of HSA-free batches of Epo was performed to understand this increase in immunogenicity. Association of Epo with polysorbate micelles, 2 formation of aggregates, 3 and the presence of leachates originating from the uncoated rubber plunger 4 were proposed as the main causes of immunogenicity. After introduction of a coated rubber plunger, contraindication of subcutaneous injection, and improvement of storage conditions, the rate of pure red-cell aplasia rapidly reached the initial background level.…”
Section: Introductionmentioning
confidence: 99%