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Plasma Products (plasma + products)
Selected AbstractsSafety and efficacy of a sucrose-formulated recombinant factor VIII product for the treatment of previously treated patients with haemophilia A in ChinaHAEMOPHILIA, Issue 4 2007J. SHI Summary., The use of plasma-derived products has contributed to a high rate of blood-borne infections among haemophilia patients in China. Recombinant factor VIII (rFVIII) products that are manufactured without human or bovine albumin and include dedicated viral inactivation steps, hold a significant safety advantage over plasma products. However, there is little information published on the use of rFVIII products in non-caucasian populations. This is the first reported evaluation of the efficacy and safety of a rFVIII product in Chinese haemophiliacs. An open-label, non-randomized, prospective, multicentre trial enroled previously treated Chinese patients with haemophilia A. All treatments were administered using a sucrose-formulated rFVIII-FS (Kogenate®). Forty-nine patients received totals of 291 infusions (mean, 5.94/patient) and 742 140 IU rFVIII-FS (mean, 2550.3 IU/infusion). Of the 60 acute bleeding episodes that were treated, 90% were successfully managed with only one (81.7%) infusion or two (8.3%) infusions. Physicians reported haemostasis control for acute bleeds to be ,Excellent' or ,Improved' with rFVIII-FS therapy. No FVIII inhibitors were detected in any patient. Only one treatment-related adverse event was reported, which was mild dizziness that resolved spontaneously. rFVIII-FS was efficacious, safe and well tolerated in the treatment of previously treated patients with haemophilia A in China. [source] Nanofiltration of plasma-derived biopharmaceutical productsHAEMOPHILIA, Issue 1 2003T. Burnouf Summary. This review presents the current status on the use and benefits of viral removal filtration systems , known as nanofiltration , in the manufacture of plasma-derived coagulation factor concentrates and other biopharmaceutical products from human blood origin. Nanofiltration of plasma products has been implemented at a production scale in the early 1990s to improve margin of viral safety, as a complement to the viral reduction treatments, such as solvent,detergent and heat treatments, already applied for the inactivation of human immunodeficiency virus, hepatitis B and hepatitis C virus. The main reason for the introduction of nanofiltration was the need to improve product safety against non-enveloped viruses and to provide a possible safeguard against new infectious agents potentially entering the human plasma pool. Nanofiltration has gained quick acceptance as it is a relatively simple manufacturing step that consists in filtering protein solution through membranes of a very small pore size (typically 15,40 nm) under conditions that retain viruses by a mechanism largely based on size exclusion. Recent large-scale experience throughout the world has now established that nanofiltration is a robust and reliable viral reduction technique that can be applied to essentially all plasma products. Many of the licensed plasma products are currently nanofiltered. The technology has major advantages as it is flexible and it may combine efficient and largely predictable removal of more than 4 to 6 logs of a wide range of viruses, with an absence of denaturing effect on plasma proteins. Compared with other viral reduction means, nanofiltration may be the only method to date permitting efficient removal of enveloped and non-enveloped viruses under conditions where 90,95% of protein activity is recovered. New data indicate that nanofiltration may also remove prions, opening new perspectives in the development and interest of this technique. Nanofiltration is increasingly becoming a routine step in the manufacture of biopharmaceutical products. [source] Evaluating risk in human plasma transfusionJOURNAL OF HEALTHCARE RISK MANAGEMENT, Issue 2 2000Fred Darr MD Medical Officer Human plasma transfusion with fresh frozen plasma can be valuable in treating a variety of hemorrhagic disorders. Although safe in most cases, fresh frozen plasma poses some risk of viral infection via transfusion. New plasma preparations, using either quarantine or viral inactivation of pooled samples to improve safety, have been made available in the United States. Distinguishing characteristics include viral safety, availability, and cost. Risk managers should be aware of the range of plasma products, as well as the issues surrounding their use, in order to participate in organizational decision-making regarding the recommendation of specific products. [source] Altered cytokine profiles in patients with Chuvash polycythemia,AMERICAN JOURNAL OF HEMATOLOGY, Issue 2 2009Xiaomei Niu Chuvash polycythemia results from a homozygous 598C>T mutation in exon 3 of the von Hippel-Lindau (VHL) gene. This disrupts the normoxia pathway for degrading hypoxia inducible factor (HIF)-1, and HIF-2, causing altered expression of HIF-1 and HIF-2 inducible genes. As hypoxia induces expression of pro-inflammatory cytokines, we hypothesized that there might be an elevation of Th1 cytokines in the setting of Chuvash polycythemia. We analyzed plasma concentrations of Th1 (interleukins-2 and 12, interferon-,, granulocyte-monocyte colony-stimulating factor, tumor necrosis factor-,) and Th2 cytokines (interleukins-4, 5, 10, and 13) using the Bio-Plex multiplex suspension array system in 34 VHL598C>T homozygotes and 32 VHL wild-type participants from Chuvashia. Concentrations of all the Th1 and Th2 cytokines measured were elevated in the VHL598C>T homozygotes compared with the control wild-type participants, but the ratios of Th1 to Th2 cytokines did not differ by genotype. In parallel, peripheral blood concentrations of CD4 positive T-helper cells and CD4/CD8 ratio were lower in the VHL598C>T homozygotes. In conclusion, the up-regulated hypoxic response in Chuvash polycythemia is associated with increased plasma products of both the Th1 and Th2 pathways, but the balance between the two pathways seems to be preserved. Am. J. Hematol., 2009. © 2008 Wiley-Liss, Inc. [source] Plasma facilitated delivery of DNA to skinBIOTECHNOLOGY & BIOENGINEERING, Issue 5 2009Richard J. Connolly Abstract Non-viral delivery of cell-impermeant drugs and DNA in vivo has traditionally relied upon either chemical or physical stress applied directly to target tissues. Physical methods typically use contact between an applicator, or electrode, and the target tissue and may involve patient discomfort. To overcome contact-dependent limitations of such delivery methodologies, an atmospheric helium plasma source was developed to deposit plasma products onto localized treatment sites. Experiments performed in murine skin showed that samples injected with plasmid DNA encoding luciferase and treated with plasma demonstrated increased levels of expression relative to skin samples that received injections of DNA alone. Increased response relative to injection alone was observed when either positive or negative voltage was used to generate the helium plasma. Quantitative results over a 26-day follow-up period showed that luciferase levels as high as 19-fold greater than the levels obtained by DNA injection alone could be achieved. These findings indicate that plasmas may compete with other physical delivery methodologies when skin is the target tissue. Biotechnol. Bioeng. 2009; 104: 1034,1040. © 2009 Wiley Periodicals, Inc. [source] | ||||||||||