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Analytical Characterization of Aberrant Trisulfide Bond Formation in Therapeutic Proteins and Their Impact on Product Quality.
J Pharm Sci
January 2025
Laboratory of Applied Biochemistry, Division of Biotechnology Review and Research III, Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.. Electronic address:
Post translational modifications (PTMs) of proteins play an integral role in maintaining the overall structure and function of proteins including their proper folding, binding, and potency. However, not all PTMs play a positive role in protein drugs as some can lead to product-related impurities that negatively impact protein function. One example of a PTM is trisulfide formation, which appears as a product related species in multiple biologic drug products.
View Article and Find Full Text PDFErythropoiesis-stimulating agent responsiveness and hemoglobin variability is associated with fat tissue index in hemodialysis patients with darbepoetin-alfa treatment: a prospective observational cohort study.
Kidney Res Clin Pract
December 2024
Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.
Background: Although the introduction of erythropoietin-stimulating agents (ESAs) has led to better clinical outcomes in patients undergoing hemodialysis (HD), fluctuations in hemoglobin (Hb) levels, known as Hb variability, are frequently observed. However, only a few studies have evaluated the association between Hb variability and nutritional status in patients undergoing HD.
Methods: In this prospective study conducted between March 1, 2020, and June 1, 2022, we included 109 patients aged over 20 years undergoing HD and receiving darbepoetin.
Study on Internal Standards Applicable to the Detection of Recombinant Erythropoietin.
Drug Test Anal
December 2024
Beijing Anti-Doping Laboratory, Beijing Sport University, Beijing, China.
Article Synopsis
- The discovery of the c.577del variant in the EPO gene has complicated testing for recombinant erythropoietin (rEPO), making detection more challenging.
- Researchers developed a new confirmation method that combines reverse-normal immunopurification, western blotting (WB), and SAR-PAGE to effectively identify both the EPO variant (VAR-EPO) and rEPO using specific antibodies.
- An internal standard (IS) made from VAR-EPO modified with polyethylene glycol (PEG) was created and shown to effectively monitor rEPO detection in urine samples, ensuring reliable doping analysis results.
2024 critical review of the patient blood management (PBM) recommendations of the Spanish enhanced recovery after major surgery (via RICA).
Cir Esp (Engl Ed)
November 2024
Servicio de Medicina Interna, Complex Hospitalari Moisès Broggi, Consorci Sanitari Integral, Sant Joan Despí, Barcelona, Spain; Grupo Multidisciplinar para el Estudio y Manejo de la Anemia del Paciente Quirúrgico (Anemia Working Group España), Madrid, Spain; Grupo Español de Rehabilitación Multimodal (GERM), Madrid, Spain; Banco de Sangre y Tejidos de Navarra, Servicio Navarro de Salud, Osasunbidea, Pamplona, Spain. Electronic address:
The Spanish enhanced recovery in adult surgery strategy, the "RICA pathway", was published in 2021 and includes 19 specific recommendations and more than 20 indirect recommendations for patient blood management (PBM). After reviewing these recommendations, and in the context of the new clinical evidence available, we propose the following updates: First: Detection and treatment of any preoperative anemia status in ALL patients who are candidates for major surgery with hematinic deficiencies. Second: Universal use of tranexamic acid in major surgery, bedside monitoring of intraoperative hemoglobin levels, restrictive transfusion criteria, and monitoring of patient well-being in terms of hydration, coagulability, normothermia and analgesia.
View Article and Find Full Text PDFHyporesponsiveness to Erythropoiesis-Stimulating Agents in Dialysis-Dependent Patients with Anaemia of Chronic Kidney Disease: A Retrospective Observational Study.
Adv Ther
November 2024
Fresenius Medical Care D GmbH, Bad Homburg, Germany.
Introduction: Hyporesponsiveness to erythropoiesis-stimulating agents (ESAs) in patients with anaemia of chronic kidney disease may lead to increased ESA doses to achieve target haemoglobin levels; however, elevated doses may be associated with increased mortality. Furthermore, patients with hyporesponsiveness to ESAs have poorer clinical outcomes than those who respond well to ESAs. Incidence and clinical characteristics of patients with ESA hyporesponsiveness were explored in a real-world setting.
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