Biologicals : journal of the International Association of Biological Standardization
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Pseudomonas aeruginosa infections are a serious challenge to therapy because of the complex pathogenesis and paucity of new effective antibiotics, thus renewing interest in antibody-based therapeutic strategies. Immunotherapy strategies typically target selected virulence factors that are expressed by the majority of clinical strains of P. aeruginosa, particularly because virulence factors mediate infection. Type a and b flagellins (flagellin a+b) of P. aeruginosa are acute virulence factors that play a major role in the establishment of infection. ⋯ A combination strategy using antibodies against "flagellin a+b" provided greater protection against cell invasion and enhanced opsono-phagocytosis and decreased motility of P. aeruginosa strains, compared to strategies using antibodies against a single flagellin. Antibodies against "flagellin a+b"-protected mice infected with P. aeruginosa strains significantly reduced bacterial dissemination from the site of infection to the liver and spleen. Passive immunization with antibodies against "flagellin a+b" led to an efficacious protection against P. aeruginosa infection in both acute pneumonia and burn models.
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This article addresses regulation of cell therapies in the European Union (EU), covering cell sourcing and applications for clinical trials and marketing authorisation applications. Regulatory oversight of cell sourcing and review of applications for clinical trials with cell therapies are handled at national level, that is, separately with each country making its own decisions. ⋯ However, at the marketing authorisation stage, the process is pan-national: the Committee for Human Medicinal Products (CHMP) is responsible for giving the final scientific opinion on all EU marketing authorisation applications for cell therapies: favourable scientific opinions are passed to the European Commission (EC) for further consultation and, if successful, grant of a marketing authorisation valid in all 28 EU countries. In its review of applications for marketing authorisations (MAAs) for cell therapies, the CHMP is obliged to consult the Committee for Advanced Therapies (CAT), who conduct detailed scientific assessments of these applications, with assessment by staff from national regulatory authorities and specialist advisors to the regulators.
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Three commonly used designs for vaccine safety assessment post licensure are cohort, case-control and self-controlled case series. These methods are often used with routine health databases and immunisation registries. This paper considers the issues that may arise when designing an epidemiological study, such as understanding the vaccine safety question, case definition and finding, limitations of data sources, uncontrolled confounding, and pitfalls that apply to the individual designs. The example of MMR and autism, where all three designs have been used, is presented to help consider these issues.
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Patient Blood Management (PBM) is a patient-focused multidisciplinary and comprehensive concept that is designed to ensure the optimal, appropriate and safe use of blood and blood products, resulting in better outcome and safety for the recipients. The World Health Organization, in May 2010, adopted a resolution in favour of PBM, on the availability, safety and quality of blood products and their safe and rational use. However, several factors may enhance or hamper this process including health care personnel, available techniques and technologies, devices, standards, guidelines and documentation, quality systems as well as coordination, monitoring and evaluation. The implications in developing countries may have other peculiarities.
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Experimental salmon thrombin/fibrinogen dressings have been shown to provide effective hemostasis in severe hemorrhage situations. The hypothesis for this study was that swine would still remain healthy without coagulopathy six months after exposure to salmon thrombin/fibrinogen dressings. Initial exposure was by insertion of the salmon dressing into the peritoneal cavity. ⋯ All of the animals (8 pigs) remained healthy during the six month period and the dermal wounds healed without incidence. Lymph nodes and spleen showed signs of normal immune response and Western blots showed development of antibodies against salmon fibrinogen, but none of the animals made antibodies that recognized any species of thrombin. Coagulation parameters (fibrinogen concentration, thrombin time, PT and aPTT) and hematological parameters remained normal over the course of the study when compared to initial values of the subject swine.