			Home About us Contact

Pathogen Inactivation (pathogen + inactivation)

Distribution by Scientific Domains

Medical Sciences	100%

Selected Abstracts

Where will pathogen inactivation have the greatest impact?

ISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue 1 2007
T. Hervig
Blood safety has always been a major task in transfusion medicine. A strategy to obtain this aim should include donor education, donor selection, and testing of blood donations. Pathogen inactivation adds another level of safety. In the fractionation industry, pathogen inactivation methods are mandatory. Several countries also use pathogen-inactivated plasma , from pools or single donors. Concerning the cellular blood components, there is still no method available for red cell concentrates, whereas methods for platelet concentrates are available in some countries and others are in the pipeline for commercialization. The efficiency of the ,old' methods to increase blood safety and the costs of the methods seem to be major obstacles for the introduction of the systems. There are also concerns on product quality and loss of volume during the inactivation process. As the importance of pathogen inactivation is largest in countries with blood donors who carry infections it is impossible to protect against, either due to high incidence of the infection or due to shortage of tests, cost will be a major question when pathogen inactivation is considered. Pathogen inactivation of red cell concentrates will also be a necessity. When pathogen inactivation methods are available for all blood components, they will have great impact to protect the patients in countries where a high percentage of the population is infected by agents transmissible through blood transfusion, and in all situations to protect against new pathogens and ,old' pathogens that become more virulent. The total risk of contracting infectious diseases through blood transfusion will probably be important when implementation of new methods for pathogen inactivation is considered. [source]

Pathogen safety of manufacturing processes for biological products: special emphasis on KOGENATE® Bayer

HAEMOPHILIA, Issue 2002
D. C. Lee
Summary., Manufacturers of human therapeutic proteins derived from biological sources continuously strive to improve the pathogen safety profiles of these products. Efforts to improve pathogen safety margins for these biological products are directed towards several areas within the manufacturing processes including: (a) sourcing and screening of raw materials (b) determining the potential for manufacturing processes to reduce pathogen titres, and (c) incorporating methods designed specifically to remove or inactivate contaminating pathogens. Methods that could potentially reduce pathogen titres are a major focus for many manufacturers. In general, these methods are grouped into two categories, pathogen clearance and pathogen inactivation. Assessments are performed on small-scale, laboratory simulations of the manufacturing process of interest that are spiked with a known amount of a selected pathogen. These studies provide estimates of the potential for a process step to remove or inactivate a particular pathogen. There are several pathogen clearance/inactivation methods that are inherent in manufacturing processes, however, some methods are intentionally incorporated into manufacturing for the sole purpose of reducing putative pathogen titres. Not only are well-known pathogens such as viruses targeted, but also suspected pathogens such as those associated with the transmissible spongiform encephalopathies (TSEs). The production processes for the isolation of several biological products, including recombinant KOGENATE® Bayer (Kogenate®FS), have been evaluated for the ability to reduce pathogen titres and/or have been designed to incorporate methods for reducing potential pathogen safety risks. Several processing steps with the potential to reduce pathogen titres have been identified. [source]

Optimal timing and dosing of platelet transfusions

ISBT SCIENCE SERIES: THE INTERNATIONAL JOURNAL OF INTRACELLULAR TRANSPORT, Issue n1 2010
N. M. Heddle
Background, Over the past 20 years there have been more than 20 randomized controlled trials (RCTs) that have investigated various aspects of platelet transfusion therapy in haematology/oncology patients. These studies have focused on the best platelet product, the importance of ABO compatibility, pathogen inactivation of platelets, platelet triggers and the optimal platelet dose. Aims, This article summarizes current evidence to support the timing and dosing of platelet transfusions and to explore some ideas of where clinical research in this area may be heading. Materials and Methods, The articles reviewed in this presentation were identified through a search of PubMed using the term, platelet transfusion and setting limits to identify clinical studies, human studies and manuscripts in English. Results and Discussion, Three RCTs have informed practices around platelet transfusion trigger with the largest study by Rebulla et al., being the primary study that has changed practices worldwide, with a move towards a lower prophylactic platelet transfusion trigger of 10 × 109/l. Two groups (Germany and Oxford, UK) are currently investigating whether we can push the boundaries of prophylactic platelet transfusions even further by eliminating this form of therapy. Preliminary results from these studies have been published but we will await the final results to determine whether this research will indeed change practice. Over the past year there has also been two major studies (one by the BEST Collaborative, and the second by the US Transfusion Medicine/Hemostasis Network), that provide new information to guide platelet dosing. The Study by the BEST Collaborative (SToP) compared low dose platelets to standard dose platelets with WHO bleeding greater than or equal to Grade 2 as the primary outcome. The US study (PLADO) compared three doses (low, medium and high) and measured the same outcome (WHO bleeding , Grade 2). Conclusions, Although all of these studies further our knowledge to prescribe platelet transfusions, they also raise some interesting questions about the clinical relevance of the outcomes that we are currently using for these studies. The trend over the past decade has been to use bleeding as the primary outcome; however, bleeding is a complex composite outcome (Grades 2, 3 and 4) comprised of some surrogate components (Grades 2 and 3). It is also an outcome that may be difficult to measure and grade in a consistent and reliable manner. The clinical relevance of this outcome is also complex and may vary depending on the perspective from which it is viewed. [source]

Where will pathogen inactivation have the greatest impact?

Bacterial detection in platelet components and the rationale for pathogen inactivation: A blood center perspective.,

JOURNAL OF CLINICAL APHERESIS, Issue 2 2005
Richard J. Benjamin
First page of article [source]

Substitutes and alternatives to platelet transfusions in thrombocytopenic patients

JOURNAL OF THROMBOSIS AND HAEMOSTASIS, Issue 7 2003
M. A. Blajchman
Summary., Over the past decade, there have been many improvements in both the safety profile and quality of liquid-stored allogeneic platelet concentrates. However, significant problems with the clinical use of such products remain. Efforts to overcome some of these have resulted in the development of an array of novel therapeutic strategies for the manufacture of platelet products and platelet substitutes, as well as other approaches using alternatives to platelet concentrates. These various products or procedures are at various stages of clinical development. This review summarizes some recent advancements in the preparation of liquid and frozen stored platelets, as well as approaches used for the pathogen inactivation of platelets. Thus, the status of lyophilized platelets, infusible platelet membranes, red blood cells (RBCs) bearing RGD ligands, fibrinogen-coated albumin microcapsules, and liposome-based agents are discussed. Pre-clinical studies and phase 1,3 clinical trials have been encouraging for several of these; however, to date, very few have been licensed for clinical use. Potential alternatives to allogeneic platelet transfusions including correction of anemia by RBC transfusions, recombinant activated factor VII and HLA-reduced platelets are also reviewed. With the ongoing technical and scientific development of such diverse products, those properties that may be necessary for such agents to have hemostatic efficacy will become apparent. However, safety and efficacy must be demonstrable in preclinical studies and clinical trials, before novel platelet concentrates, platelet substitutes and alternatives to platelets can be used in patients with thrombocytopenia. [source]