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https://www.readbyqxmd.com/read/28509534/analysis-of-three-epoetin-alpha-products-by-lc-and-lc-ms-indicates-differences-in-glycosylation-critical-quality-attributes-including-sialic-acid-content
#1
Rebecca I Thomson, Richard Andrew Gardner, Katja Strohfeldt, Daryl L Fernandes, Graham Philip Stafford, Daniel I R Spencer, Helen M I Osborn
Erythropoietin (EPO) is one of the main treatments for anaemic patients, greatly improving their quality of life. In this study, biosimilars Binocrit and a development product, called here CIGB-EPO, were compared to the originator product, Eprex. All three are epoetin alpha products, reputed to have similar glycosylation profiles. The quality, safety and efficacy of this biotherapeutic depend on the following glycosylation critical quality attributes (GCQAs): sialylation, N-glycolyl-neuraminic acid (Neu5Gc) content, branching, N-acetyl-lactosamine (LacNAc) extensions and, arguably, O-acetylation pattern...
May 16, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28346912/optimizing-the-dose-of-erythropoietin-required-to-prevent-acute-ventilation-induced-cerebral-white-matter-injury-in-preterm-lambs
#2
Kyra Y Y Chan, Domenic A LaRosa, Mary Tolcos, Anqi Li, Valerie A Zahra, Graeme R Polglase, Samantha K Barton
Erythropoietin (EPO) is being trialed in preterm neonates for neuroprotection. We have recently demonstrated that a single high bolus dose (5,000 IU/kg) of recombinant human EPO amplified preterm lung and brain ventilation-induced injury. We aimed to determine the optimal dose of EPO to reduce ventilation-induced cerebral white matter inflammation and injury in preterm lambs. Lambs (0.85 gestation) were ventilated with an injurious strategy for 15 min followed by conventional ventilation for 105 min. Lambs were randomized to no treatment (VENT; n = 8) or received a bolus dose of EPO (EPREX®): 300 IU/kg (EPO 300; n = 5), 1,000 IU/kg (EPO 1,000; n = 5), or 3,000 IU/kg (EPO 3,000; n = 5)...
March 28, 2017: Developmental Neuroscience
https://www.readbyqxmd.com/read/28344481/stability-of-erythropoietin-repackaging-in-polypropylene-syringes-for-clinical-use
#3
Angela Marsili, Giorgia Puorro, Chiara Pane, Anna de Rosa, Giovanni Defazio, Carlo Casali, Antonio Cittadini, Giuseppe de Michele, Brunello Ettore Florio, Alessandro Filla, Francesco Saccà
Introduction: Epoetin alfa (Eprex®) is a subcutaneous, injectable formulation of short half-life recombinant human erythropoietin (rHuEPO). To current knowledge there are no published studies regarding the stability of rHuEPO once repackaging occurs (r-EPO) for clinical trial purposes. Materials and methods: We assessed EPO concentration in Eprex® and r-EPO syringes at 0, 60, 90, and 120 days after repackaging in polypropylene syringes. R-EPO was administered to 56 patients taking part in a clinical trial in Friedreich Ataxia...
February 2017: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/27932518/epoetin-%C3%AE-induced-pure-red-cell-aplasia-an-unintended-consequence
#4
Muhammad Masoom Javaid, Priyanka Khatri, Srinivas Subramanian
Pure red cell aplasia is a rare condition associated with the use of recombinant human erythropoietin preparations. It has predominantly been associated with the subcutaneous use of a particular epoetin-α product, Eprex, and is rarely associated with intravenous use or with other commercially available products. Only a few cases of pure red cell aplasia secondary to epoetin-β have been reported. On account of its rarity, the condition can often be missed on initial presentation, leading to unnecessary investigations and delayed diagnosis...
March 2017: Postgraduate Medical Journal
https://www.readbyqxmd.com/read/27390252/new-insights-for-identification-of-doping-with-recombinant-human-erythropoietin-micro-doses-after-high-hydration
#5
L Martin, M Ashenden, J Bejder, M Hoffmann, N Nordsborg, K Karstoft, J Morkeberg, K Sharpe, F Lasne, A Marchand
To minimize the chances of being caught after doping with recombinant human erythropoietins (rhEPO), athletes have turned to new practices using micro-doses and excess fluid ingestion to accelerate elimination and decrease the probability of detection. Our objective was to test the sensitivity of detection by validated methods (IEF: isoelectric focusing; SDS-PAGE: sodium dodecyl sulfate polyacrylamide gel electrophoresis) when such practices are used. First, after a three-week rhEPO boost period and 10 days of wash out, detection of a single 900 IU micro-dose of Eprex® was evaluated in healthy male subjects...
November 2016: Drug Testing and Analysis
https://www.readbyqxmd.com/read/27348021/a-cluster-of-epoetin-associated-pure-red-cell-aplasia-clinical-features-and-the-possible-association-of-hla-drb1-12-02
#6
Chuen Wen Tan, Wei-Chuen Tan-Koi, Jennifer Ng, Choong Meng Chan, William Ying Khee Hwang
Antibody-mediated pure red cell aplasia is a rare but serious complication in chronic kidney disease patients receiving recombinant human erythropoietin (r-HuEpo). Between April 2012 and May 2013, eight such cases were reported in our institution. Their clinical features were reviewed and their HLA alleles were compared with those of healthy controls. All patients were exposed to epoetin alfa (Eprex(®)) with polysorbate-80 as stabilizer via subcutaneous route with a mean age of 61.9 years and mean exposure of 11...
June 27, 2016: Pharmacogenomics
https://www.readbyqxmd.com/read/27317353/understanding-the-biosimilar-approval-and-extrapolation-process-a-case-study-of-an-epoetin-biosimilar
#7
REVIEW
Amit B Agarwal, Ali McBride
The World Health Organization defines a biosimilar as "a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product." Biosimilars are biologic medical products that are very distinct from small-molecule generics, as their active substance is a biological agent derived from a living organism. Approval processes are highly regulated, with guidance issued by the European Medicines Agency and US Food and Drug Administration. Approval requires a comparability exercise consisting of extensive analytical and preclinical in vitro and in vivo studies, and confirmatory clinical studies...
August 2016: Critical Reviews in Oncology/hematology
https://www.readbyqxmd.com/read/27181179/effect-of-recombinant-erythropoietin-on-inflammatory-markers-in-patients-with-affective-disorders-a-randomised-controlled-study
#8
Maj Vinberg, Pia Weikop, Niels Vidiendal Olsen, Lars Vedel Kessing, Kamilla Miskowiak
AIM: This study investigated the effect of repeated infusions of recombinant human erythropoietin (EPO) on markers of inflammation in patients with affective disorders and whether any changes in inflammatory markers were associated with improvements on verbal memory. METHODS: In total, 83 patients were recruited: 40 currently depressed patients with treatment-resistant depression (TRD) (Hamilton Depression Rating Scale-17 items (HDRS-17) score >17) (sub-study 1) and 43 patients with bipolar disorder (BD) in partial remission (HDRS-17 and Young Mania Rating Scale (YMRS)⩽14) (sub-study 2)...
October 2016: Brain, Behavior, and Immunity
https://www.readbyqxmd.com/read/27107522/sleep-disorders-in-esrd-patients-undergoing-hemodialysis
#9
Mohammad Reza Abassi, Amin Safavi, Masoumeh Haghverdi, Babak Saedi
Kidney failure affects different aspects of normal life. Among different manifestations, sleep problem can be considered as a common complaint of ESRD (End Stage Renal Disease) patients. In this study, we aimed to investigate the interrelationship between sleep disorders in ESRD patients and their characteristics. Through a cross-sectional study (2010-2011), 88 ESRD patients undergoing maintenance hemodialysis thrice weekly were recruited to enter the study. We used a self-administered questionnaire into which the data were reflected...
March 2016: Acta Medica Iranica
https://www.readbyqxmd.com/read/26959544/optimization-of-amino-acid-stabilized-erythropoietin-parenteral-formulation-in-vitro-and-in-vivo-assessment
#10
Bahgat E Fayed, Abdulkader F Tawfik, Alaa Eldeen B Yassin
The aim of this study was to optimize the formulation of erythropoietin (EPO) using amino acids instead of human serum albumin (HSA) and to evaluate its in vivo stability in order to avoid the risk of viral contamination and antigenicity. Different EPO formulations were developed in such a way as to allow studying the effects of amino acids and surfactants on the EPO stability profile. The main techniques applied for EPO analysis were ELISA, Bradford method, and SDS gel electrophoresis. The in vivo stability was evaluated in a Balb-c mouse animal model...
March 2016: Acta Pharmaceutica
https://www.readbyqxmd.com/read/26899770/improved-heart-function-from-older-donors-using-pharmacologic-conditioning-strategies
#11
Gayathri Kumarasinghe, Ling Gao, Mark Hicks, Jeanette Villanueva, Aoife Doyle, Padmashree Rao, Min Ru Qiu, Andrew Jabbour, Arjun Iyer, Hong Chee Chew, Christopher S Hayward, Peter Macdonald
BACKGROUND: Hearts from older donors are increasingly being referred for transplantation. However, these hearts are more susceptible to ischemia-reperfusion injury (IRI), reflected in higher rates of primary graft dysfunction. We assessed a strategy of pharmacologic conditioning, supplementing Celsior (Genzyme, Naarden, The Netherlands) preservation solution with glyceryl trinitrate (GTN; Hospira Australia Pty, Ltd, Mulgrave, VIC, Australia), erythropoietin (EPO; Eprex; Janssen-Cilag, North Ryde, NSW, Australia), and zoniporide (ZON; Pfizer, Inc...
May 2016: Journal of Heart and Lung Transplantation
https://www.readbyqxmd.com/read/26869417/quality-and-batch-to-batch-consistency-of-original-and-biosimilar-epoetin-products
#12
Liem Andhyk Halim, Vera Brinks, Wim Jiskoot, Stefan Romeijn, Rob Haselberg, Chris Burns, Meenu Wadhwa, Huub Schellekens
Comprehensive physicochemical characterization and biological assays are essential parts in assessing quality attributes of biologicals. Here, we compared the quality of different marketed recombinant human erythropoietin (epoetin) products: originators, Eprex and NeoRecormon as well as 2 biosimilars, Retacrit and Binocrit. In addition, assessment of batch-to-batch variability was included by collecting 2 or more batches of each product. Common assays which included sodium dodecyl sulfate-polyacrylamide gel electrophoresis, high-performance size-exclusion chromatography, asymmetrical flow field-flow fractionation, capillary zone electrophoresis, and potency testing were used...
February 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/26594121/evaluation-of-a-biosimilar-recombinant-alpha-epoetin-in-the-management-of-anemia-in-hemodialysis-patients
#13
Fatemeh Beiraghdar, Yunes Panahi, Behzad Einollahi, Eghlim Nemati, Amirhossein Sahebkar, Arash Hassanzadeh, Hamid T Khosroshahi, Sima A Azar, Javid Safa, Sadroddin R Hashemi, Jalal Etemadi, Eisa T Marzony, Hamid Noshad
BACKGROUND: The efficacy of human recombinant erythropoietins (rHuEPOs) in the treatment of anemia with different etiologies is proven. Development of biosimilar rHuEPO products with lower cost and wider availability is important for the care of anemic patients. OBJECTIVE: The aim of the present study was to determine the bioequivalence and safety of a biosimilar rHuEPO (Pastopoitin(®)) and compare it with the innovator product Eprex(®), as a standard rHuEPO. METHODS: One hundred and seven anemic patients on stable hemodialysis were recruited to this randomized double-blind comparative trial and assigned to either subcutaneous Pastopoitin (n = 50) or Eprex (n = 57)...
October 2015: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
https://www.readbyqxmd.com/read/26369656/pharmacokinetic-and-pharmacodynamic-comparison-of-two-recombinant-human-erythropoietin-formulations-pda10-and-eprex-in-healthy-korean-male-volunteers-a-randomized-double-blinded-single-dose-two-period-crossover-study
#14
RANDOMIZED CONTROLLED TRIAL
MinKyung Oh, Jaeseung Yoon, Doo-Yeoun Cho
BACKGROUND AND OBJECTIVES: A new biosimilar human recombinant epoetin alfa product (PDA10) has been developed by PanGen Biotech Inc., Korea. This study was planned to demonstrate the pharmacokinetic and pharmacodynamic comparability of PDA10 to an existing epoetin alfa (Eprex) after a single intravenous administration to healthy adult male volunteers. METHODS: A randomized, double-blinded, single-dose, crossover study was conducted in 30 subjects. The subjects were assigned randomly to one of two sequence groups, and single doses of 100 IU/kg PDA10 or Eprex were administered intravenously on each of 2 treatment days separated by a 4-week washout period...
October 2015: Clinical Drug Investigation
https://www.readbyqxmd.com/read/26361727/computational-and-functional-analysis-of-biopharmaceutical-drugs-in-zebrafish-erythropoietin-as-a-test-model
#15
Michela Guarienti, Edoardo Giacopuzzi, Alessandra Gianoncelli, Sandra Sigala, Pierfranco Spano, Sergio Pecorelli, Luca Pani, Maurizio Memo
The zebrafish (Danio rerio) is a very popular vertebrate model system, especially embryos represent a valuable tool for in vivo pharmacological assays. This is mainly due to the zebrafish advantages when compared to other animal models. Erythropoietin is a glycoprotein hormone that acts principally on erythroid progenitors, stimulating their survival, proliferation and differentiation. Recombinant human erythropoietin (rhEPO) has been widely used in medicine to treat anemia and it is one of the best-selling biotherapeutics worldwide...
December 2015: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/26332509/differential-short-term-regional-effects-of-early-high-dose-erythropoietin-on-white-matter-in-preterm-lambs-after-mechanical-ventilation
#16
Samantha K Barton, Annie R A McDougall, Jacqueline M Melville, Timothy J M Moss, Valerie A Zahra, Tammy Lim, Kelly J Crossley, Graeme R Polglase, Mary Tolcos
Inadvertently injurious ventilation of preterm neonates in the delivery room can cause cerebral white matter (WM) inflammation and injury. We investigated the impact of an early high dose of recombinant human erythropoietin (EPO) on ventilation-induced WM changes in preterm lambs. Injurious ventilation, targeting a V(T) of 15 ml kg(-1) with no positive end-expiratory pressure, was initiated for 15 min in preterm lambs (0.85 gestation). Conventional ventilation was continued for a further 105 min. Lambs received either 5000 IU kg(-1) of EPO (EPREX®; Vent+EPO; n = 6) or vehicle (Vent; n = 8) via an umbilical vein at 4 ± 2 min...
March 1, 2016: Journal of Physiology
https://www.readbyqxmd.com/read/26290355/identification-of-recombinant-human-epo-variants-in-greyhound-plasma-and-urine-by-elisa-lc-ms-ms-and-western-blotting-a-comparative-study
#17
Mark Timms, Rohan Steel, John Vine
The recombinant human erythropoietins epoetin alfa (Eprex®), darbepoetin (Aranesp®) and methoxy polyethylene glycol-epoetin beta (Mircera®) were administered to greyhounds for 7, 10 and 14 days respectively. Blood and urine samples were collected and analysed for erythropoietin by ELISA, LC-MS/MS and western blotting. Limits of confirmation in plasma for western blotting and LC-MS/MS methods ranged from a low of 2.5mIU/mL, and closely matched the sensitivity of ELISA screening.
February 2016: Drug Testing and Analysis
https://www.readbyqxmd.com/read/25439107/-quipo-who-inject-epo
#18
MULTICENTER STUDY
Cécile Vigneau, Sylvie Le Stum, Corinne Isnard-Bagnis, Gabriel Choukroun, Yannick Lemeur, Nassim Kamar, Emmanuel Oger
INTRODUCTION: Erythropoiesis Stimulating Agents (ESA) are largely prescribed before dialysis stage to chronic kidney disease patients. In accordance to current international guidelines, lots have been made by pharmacological companies in order to improve self management of ESAs: subcutaneaous administration, pencil devices, mutidose cartridges, low injection volume, very fine needles, once a month injections but none is currently known on the percentage of patients who actually do self administration of ESAs...
December 2014: Néphrologie & Thérapeutique
https://www.readbyqxmd.com/read/25250536/safety-and-biosimilarity-of-ior-%C3%A2-epocim-compared-with-eprex-%C3%A2-based-on-toxicologic-pharmacodynamic-and-pharmacokinetic-studies-in-the-sprague-dawley-rat
#19
COMPARATIVE STUDY
Kresimir Pucaj, Katherine Riddle, Simon R Taylor, Nuris Ledon, Gordon T Bolger
This study examined the safety, pharmacodynamic (PD), and pharmacokinetic (PK) biosimilarity of the human recombinant erythropoietin (EPO) products ior(®) EPOCIM and Eprex(®) following a 28-day repeated intravenous dose administration in male and female Sprague-Dawley rats with a 14-day recovery period. Safety profiling was based on clinical observations, clinical pathology, and pathology findings for control rats dosed with vehicle and rats dosed either with 30, 300, and 600 I.U./kg of ior(®) EPOCIM or 600 I...
November 2014: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/25239637/incidence-of-erythropoietin-antibody-mediated-pure-red-cell-aplasia-the-prospective-immunogenicity-surveillance-registry-prims
#20
MULTICENTER STUDY
Iain C Macdougall, Nicole Casadevall, Francesco Locatelli, Christian Combe, Gerard M London, Salvatore Di Paolo, Andreas Kribben, Danilo Fliser, Hans Messner, John McNeil, Paul Stevens, Antonio Santoro, Angel L M De Francisco, Paul Percheson, Anna Potamianou, Arnaud Foucher, Daniel Fife, Véronique Mérit, Els Vercammen
BACKGROUND: Subcutaneous administration of Eprex(®) (epoetin alfa) in patients with chronic kidney disease (CKD) was contraindicated in the European Union between 2002 and 2006 after increased reports of anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA). The Prospective Immunogenicity Surveillance Registry (PRIMS) was conducted to estimate the incidence of antibody-mediated PRCA with subcutaneous administration of a new coated-stopper syringe presentation of Eprex(®) and to compare this with the PRCA incidence with subcutaneous NeoRecormon(®) (epoetin beta) and Aranesp(®) (darbepoetin alfa)...
March 2015: Nephrology, Dialysis, Transplantation
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