Glycan analysis of erythropoiesis-stimulating agents

In this study, a combination of chromatography and mass spectrometry analysis has been used to characterise and compare the glycosylation profiles of five ESA products; Eprex® (epoetin alfa), NeoRecormon® (epoetin beta), Binocrit® (epoetin alfa biosimilar), Silapo (epoetin alfa biosimilar) and Aranesp® (darbepoetin alfa). The methods utilised include mixed-mode anion-exchange/hydrophilic interaction chromatography (AEX/HILIC-MS) for N-glycan identification and quantitation, and HILIC-MS for O-glycan characterisation. The products exhibit notable differences in N- and O-glycosylation, including attributes such as sialic acid occupation, O-acetylation, N-acetyllactosamine extended antennae and sulphated/penta-sialylated N-glycans, which have the potential to cause divergence of therapeutic potencies. The study highlights the need for continued monitoring of ESA product glycosylation, ideally allied to pharmacological data, in order to ensure consistency and therapeutic equivalence between products and enhance our understanding of ESA structure-activity-relationships.
Source: Journal of Pharmaceutical and Biomedical Analysis - Category: Drugs & Pharmacology Source Type: research

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CONCLUSIONS: Cellular therapy with MSCs is very promising and should be part of the treatment of AKI patients in combination with other approaches already available, helping to accelerate recovery and/or slow the progression to chronic kidney disease. Randomized, multicentre controlled studies are needed to develop robust protocols that validate population-based cell therapy with MSCs.
Source: Revista da Associacao Medica Brasileira - Category: General Medicine Source Type: research
ConclusionsSwitching between ESAs was frequent in both CKD and cancer patients. The number of cumulative transfusions and severity of disease seemed to affect the switch.
Source: BioDrugs - Category: Drugs & Pharmacology Source Type: research
Publication date: Available online 5 August 2019Source: American Journal of Kidney DiseasesAuthor(s): Sumeska Thavarajah, Michael J. ChoiErythropoiesis-stimulating agents (ESAs) have been used to manage anemia in chronic kidney disease (CKD) to reduce transfusion requirements and anemia symptoms. Lack of objective benefit of normalizing hemoglobin (Hb) levels and increased evidence of ESA-induced complications in persons with anemia has resulted in clinicians generally attempting to maintain Hb levels in the 10- to 11-g/dL range. In 2000, concerns in patients with cancer arose attributable to associations of ESA use with i...
Source: American Journal of Kidney Diseases - Category: Urology & Nephrology Source Type: research
A remarkable feature of erythropoiesis is the coordination of proliferation, differentiation and apoptosis of erythroid cells to precisely achieve erythropoietic homeostasis to avoid anemia and polycythemia. Anemia is a common disease arising from various causes, including Myelodysplastic syndromes, thalassemia, cancer chemotherapy, chronic kidney disease and hemorrhage. The pro-erythropoietic factor erythropoietin (EPO) is often employed for anemia therapy. However, questions have been raised about the safety of EPO given its potential for tumor promotion in cancer-related anemia. Moreover, many acute and chronic anemias,...
Source: Blood - Category: Hematology Authors: Tags: 502. Hematopoiesis: Regulation of Gene Transcription, Cytokines, Signal Transduction, Apoptosis, and Cell Cycle Regulation: Poster III Source Type: research
Anemia is a condition characterized by a deficiency of red blood cells (RBCs) or hemoglobin (Hb), resulting in a diminished capacity of the blood to carry and deliver oxygen to tissues and organs (Abbasi et al., 2014). Anemia is often multifactorial in etiology and may be patient- (e.g., iron-deficiencies, vitamin deficiencies), disease- (e.g., bone marrow diseases, chronic diseases, hemorrhage), or anticancer treatment- (e.g., chemotherapy, radiotherapy, precision therapies) related (Crathorne et al., 2016).
Source: Critical Reviews in Oncology Hematology - Category: Cancer & Oncology Authors: Source Type: research
The first biosimilar to epoetin alfa for patients with anemia from chronic kidney disease, chemotherapy, or zidovudine treatment for HIV infection has receivedFDA approval.
Source: JAMA - Category: General Medicine Source Type: research
The Food and Drug Administration on Tuesday approved Retacrit as a biosimilar to treat anemia caused by chronic kidney disease and chemotherapy.
Source: Health News - - Category: Consumer Health News Source Type: news
May 15, 2018 -- The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in...
Source: - New Drug Approvals - Category: Drugs & Pharmacology Source Type: news
The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce the chance that red blood cell transfusions will be needed because of blood loss during surgery.
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news
​BY NOURA MAHDI; DARRON LEWIS; JEREMY OSBORNE; &AHMED RAZIUDDIN, MDA 73-year-old man was brought to the emergency department from his nursing home for rectal bleeding and anemia. The patient mentioned he had had episodes of bright red rectal bleeding and constipation for a few months. A colonoscopy had been done prior to the visit, which revealed a large intestine tumor and biopsy confirming adenocarcinoma. He was awaiting an appointment with his surgeon.The patient reported bloody rectal leakage, and a CBC done at the nursing home showed a hemoglobin level of 7.2. He also complained of dyspnea but denied any other s...
Source: The Case Files - Category: Emergency Medicine Tags: Blog Posts Source Type: research
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