Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
A sudden, unprecedented failure of USP rabbit pyrogen tests for multiple 10% IGIV-C lots prompted a thorough investigation of the root cause for this phenomenon. All microbe-related testing, including Limulus amebocyte lysate test for endotoxin, proved negative, and no deficiencies were discovered in manufacturing. Plasma pool composition analysis revealed that a single plasma donor ("Donor X″) was common to all pyrogenic IGIV-C lots and that as little as one unit of "Donor X″ plasma (in a pool of ∼4500 units) was sufficient to cause IGIV-C lot failure in the USP rabbit pyrogen test. Whole plasma and Protein A-purified IgG from "Donor X″ caused a temperature increase in rabbits; however, all IgG samples tested pyrogen-negative in two in vitro cell-based pyrogen tests. Flow cytometry showed that "Donor X″ IgG bound strongly to rabbit white blood cells (WBC) but minimally to human WBC. Exclusion of "Donor X″ plasma from manufacturing marked the end of IGIV-C lots registering positive in the USP rabbit pyrogen test. This failure of multiple 10% IGIV-C lots to pass the USP rabbit pyrogen test was demonstrated to be due to the highly unusual anti-rabbit-leukocyte specificity of IgG from a single donor.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.biologicals.2019.04.001 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Unveiling the Ethics of Chinese Biobank: Insights from Consent Document Analysis.
J Empir Res Hum Res Ethics
September 2025
School of Population Medicine and Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Biobanking in China has seen rapid development, placing the country as a key player globally. However, significant ethical challenges arise, particularly around donor autonomy in informed consent for collecting and using biological materials and personal data. This study examines how Chinese biobanks inform donors about their participation and the ethical content of consent documents.
View Article and Find Full Text PDFDonor site healing in follicular unit extraction hair transplantation: current evidence, cellular mechanisms, and future research directions.
Cell Mol Biol (Noisy-le-grand)
September 2025
Arencibia Clinic, San Sebastian, Spain.
Follicular unit extraction (FUE) has become a leading technique in hair transplantation, yet optimal management of the donor area remains a clinical challenge. This systematic review analyzes intraoperative and postoperative interventions applied to the donor area in FUE hair transplantation, with a focus on both clinical outcomes and the cellular and molecular mechanisms involved in tissue repair, inflammatory response, and regenerative processes. A comprehensive literature search was conducted in PubMed and EMBASE (January 2000-June 2025), identifying clinical studies that evaluated donor area treatments and reported outcomes related to healing, inflammation, infection, and patient satisfaction.
View Article and Find Full Text PDFIncreased serologic reactivity with automated CMIA testing and its implications for deceased donor eligibility determination in the United States.
Cell Tissue Bank
September 2025
Eurofins Donor & Product Testing, LLC, Centennial, CO, USA.
In the United States, the use of Food & Drug Administration (FDA)-licensed, approved, or cleared tests is required for infectious disease screening and determining the eligibility of deceased donors for all Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). With the discontinuation of two manual enzyme-linked immunoassay (EIA) tests, automated Chemiluminescent Microparticle Immunoassay (CMIA) technology was introduced as the primary alternative. This study compares serologic reactivity rates between manual EIA and automated CMIA methods.
View Article and Find Full Text PDFThermodynamic and Kinetic Effects in Spin Blocking of CO Coordination Reactions.
Inorg Chem
September 2025
Department of Chemistry, Indiana University, 800 E. Kirkwood Avenue, Bloomington, Indiana 47405, United States.
The iron(I) dinitrogen complex PhB(AdIm)FeN, which is supported by a very bulky 1-adamantyl-substituted tris(carbene)borate ligand, reacts with equimolar CO at low temperature to afford the high spin ( = 3/2) complex PhB(AdIm)Fe(CO). This monocarbonyl complex reacts with additional CO to afford the low spin ( = 1/2) dicarbonyl complex PhB(AdIm)Fe(CO). By contrast, the high spin iron(I) tris(pyrazolyl)borate complex TpFe(CO) does not react with additional CO.
View Article and Find Full Text PDFIncreased Plasma ST2 Levels Precede the Development of Severe Acute GvHD and Chronic GvHD After Pediatric Hematopoietic Stem Cell Transplantation.
Pediatr Blood Cancer
September 2025
Department of Pediatrics and Adolescent Medicine, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.
Background: The suppressor of tumorigenesis 2 (ST2) has emerged as one of the most promising biomarkers for predicting mortality of acute graft-versus-host disease (aGvHD) when measured at the onset of symptoms, but detailed time course studies are needed to understand the potential of ST2 as a risk marker of both aGvHD and chronic graft-versus-host disease (cGvHD), potentially allowing pre-emptive adjustment of immunosuppressive treatment.
Procedure: We measured ST2 levels in 117 children undergoing standard hematopoietic stem cell transplantation (HSCT) before conditioning and at regular intervals post-HSCT.
Results: ST2 levels were significantly increased from Day +7 in patients developing aGvHD of any grade (no GvHD: 23.