Dealing with the uncertain risk of variant <scp>C</scp>reutzfeldt‐<scp>J</scp>akob disease transmission by coagulation replacement products

Millar, Carolyn M.; Makris, Mike

doi:10.1111/j.1365-2141.2012.09201.x

Cited by 18 publications

(13 citation statements)

References 47 publications

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“…There is a risk of contamination with viruses, prions, bacteria, nanobacteria, mycoplasma, yeast, fungi, and endotoxins (Brockbank, Heacox, & Schenke-Layland, 2011;Doucet et al, 2005;Urbano & Urbano, 2007). Among zoonoses that may be transmitted through animal-origin agents are anthrax, Q-fever, and Creutzfeld-Jakob disease (Brockbank et al, 2011;Millar & Makris, 2012). Before more advanced methods for serum purification were developed, most frequently found contaminants in FBS were infectious bovine rhinotracheitis virus, parainfluenza-3, and bovine viral diarrhea virus (Erickson, Bolin, & Landgraf, 1991;Wisher, 2013).…”

Section: Safety Risksmentioning

confidence: 99%

Fetal bovine serum-free culture of endothelial progenitor cells-progress and challenges

Bauman

Granja

Barrias

2018

J Tissue Eng Regen Med

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Two decades after the first report on endothelial progenitor cells (EPC), their key role in postnatal vasculogenesis and vascular repair is well established. The therapeutic potential of EPC and their growing use in clinical trials calls for the development of more robust, reproducible, and safer methods for the in vitro expansion and maintenance of these cells. Despite many limitations associated with its usage, fetal bovine serum (FBS) is still widely applied as a cell culture supplement. Although different approaches aiming at establishing FBS-free culture have been developed for many cell types, adequate solutions for endothelial cells, and for EPC in particular, are still scarce, possibly due to the multiple challenges that have to be faced when culturing these cells. In this review, we provide a brief overview on the therapeutic relevance of EPC and critically analyse the available literature on FBS-free endothelial cell culture methods, including xeno-free, serum-free, and chemically defined systems.

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Section: Safety Risksmentioning

confidence: 99%

Fetal bovine serum-free culture of endothelial progenitor cells-progress and challenges

Bauman

Granja

Barrias

2018

J Tissue Eng Regen Med

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“…However, this patient received multiple blood transfusions as well as FVIII concentrate and the relevant contribution of each is uncertain [8]. Significant uncertainty about the transmissibility of vCJD by concentrates remains, and the UK population of haemophiliac patients remains under close surveillance for the development of this infection [7,9].…”

Section: Reviewmentioning

confidence: 99%

Safety surveillance in haemophilia and allied disorders

Lassila

Makris

2016

J Intern Med

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The introduction of clotting factor concentrates has transformed the lives of persons with inherited bleeding disorders. With the use of prophylactic treatment, it is now possible to prevent bleeding in these individuals. The early concentrates were contaminated with the HIV and hepatitis C viruses (HCV) and resulted in major morbidity and mortality in the recipients. Current products are much safer, especially in terms of infectious agents, but other adverse events such as alloantibodies (inhibitors), allergic reactions and thrombotic risks remain of concern. Approximately 30% of previously untreated patients with severe haemophilia A develop inhibitors, making this the most important issue in haemophilia care today. Recently, it was suggested that one of the most commonly used concentrates was associated with a higher inhibitor risk, but this was not supported by the evidence from all studies. Good safety surveillance systems are essential for all diseases and products but are particularly so in the group of individuals with inherited bleeding disorders treated with clotting factor concentrates who have suffered disproportionately from the adverse effects of their treatment. National and multinational systems are now in place to allow reporting of adverse events in patients with inherited bleeding disorders. All clinicians treating individuals with inherited bleeding disorders should prospectively report adverse events to treatment even if they are believed to be common and well recognized.

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“…Emerging infectious disease agents associated with potential blood, plasma or FVIII concentrate transmission(39,(42)(43)(44)(45)(46)(47)(48)(49) …”

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confidence: 99%

Innovative approach for improved rFVIII concentrate

Morfini

2014

European J of Haematology

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The development of a new recombinant factor VIII was designed and implemented to answer a number of unmet needs of patients affected by hemophilia A. Turoctocog alfa is bioengineered in a specific Chinese hamster ovary clone to present translational and posttranslational characteristics (sulphation, glycosylation) biosimilar to natural circulating forms of FVIII, with the aim to devoid any minimal change which may impact immunogenicity and antigenicity of recombinant protein. Both producer cell line and media are maintained free of any animal or human plasma derivative. Downstream processes of purification are performed by five steps (immunoaffinity chromatography, ion-exchange chromatography, virus inactivation by means of solvent-detergent treatment and nanofiltration, and to end with gel filtration), to provide the best possible margin of safety from known and unknown infectious agents. Large clinical trials seem to confirm the expectations placed in Turoctocog alfa in terms of high quality and safety of recombinant FVIII toward the goal of overcoming actual and future challenges of hemophilia therapy.

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Dealing with the uncertain risk of variant Creutzfeldt‐Jakob disease transmission by coagulation replacement products

Cited by 18 publications

References 47 publications

Fetal bovine serum-free culture of endothelial progenitor cells-progress and challenges

Fetal bovine serum-free culture of endothelial progenitor cells-progress and challenges

Safety surveillance in haemophilia and allied disorders

Innovative approach for improved rFVIII concentrate

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