New plasma protein C and protein S concentrate: A synergy for therapeutic purposes.

BACKGROUND AND OBJECTIVES: Deficiencies of protein C (PC) or protein S (PS) are rare diseases, characterized by mutations in the PC or PS genes, which encode plasma serine proteases with anti-coagulant activity. Severe PC or PS deficiencies manifest in early life as neonatal purpura fulminans, a life-threatening heamorrhagic condition requiring immediate treatment. First-line treatment involves replacement therapy, followed by maintenance with anti-coagulants. Replacement therapy with specific protein concentrates is currently only limited to PC, and therefore, a PC + PS concentrate represents a useful addition to therapeutic options, particularly for severe PS deficiency. Further, the production of a PC + PS concentrate from unused plasma fractionation intermediates would impact favourably on manufacturing costs, and consequently therapy prices for patients and health systems. MATERIALS AND METHODS: Several chromatographic runs were performed on the same unused plasma fractionation intermediates using different supports to obtain a PC/PS concentrate. The best chromatographic mediums were chosen, in terms of specific activity and recovery. A full process of purification including virus inactivation/removal and lyophilization steps was set up. RESULTS: The final freeze-dried product had a mean PC concentration of 47.75 IU/mL with 11% of PS, and a mean specific activity of 202.5 IU/mg protein, corresponding to over 12,000-fold purification from plasma. CONCLUSION: The development of a novel concentrated PC/PS mixture obtained from a waste fraction of other commercial products could be used for its potential therapeutic role in the management of neonatal purpura fulminans pathology.

[Students, clinical nurse preceptors and academic tutors' perception and experience in relation to the implementation of a Dedicated Education Unit: a qualitative study using focus group.] / Percezione ed esperienza di studenti, assistenti di tirocinio e tutor universitari in relazione all'implementazione di una Dedicated Education Unit: una ricerca qualitativa con focus group.

OBJECTIVE: analyse students, clinical nurse preceptors and academic tutors' perception and experience further to the implementation of a Dedicated Education Unit (DEU) in a pulmonary medicine ward. METHOD: The study follows a qualitative descriptive method. Data have been collected through focus groups (FGs). We have organized four different FGs, a specific focus group for each stakeholder (students, nurses and tutors) and a closing one with everybody. Each FG followed a qualitative content analysis method. Students had to fill in the CLES+T questionnaire to confirm qualitative data. RESULTS: Participants: 6 tutors, 7 nurses and 10 students (i.e. 6 first-year, 2 second-year and 2 third-year students). The experience has been positive. We have found four different themes, both cross-sectional and specific, in relation to positive aspects. 1. Briefing and debriefing as discussion and learning opportunities (cross-sectional); 2. Peer education potentialities (cross-sectional); 3. Global and holistic care (students); 4. Academic tutors as ward resources (cross-sectional). In relation to critical aspects, instead, we have highlighted a macro-theme, which refers to "Organizational peculiarities" and is composed of three subthemes: 1. Workload (tutors and nurses); 2. Inhomogeneity in nurses and tutors' behaviour/attitude (cross-sectional); 3. Lack of a personal relationship between students and training assistants (students). All the ameliorative proposals are related to organizational peculiarities. CONCLUSION: This study reports the first Italian experimentation of the DEU training organization model. The experience has been very positive: it has not only promoted a moment's reflection but also provided the opportunity for both the Clinical and the Academic setting to discuss and collaborate to reach the common goal, i.e. best student learning.

Different behavior of erythrovirus B19 and torquetenovirus in response to a single step of albumin purification.

BACKGROUND: The safety of human serum albumin (HSA) is of special interest with respect to virus transmission because of the wide use of this blood product as a therapeutic agent and also, added to other products, as an excipient or a stabilizer. Conflicting data are reported concerning HSA contamination by small, naked viruses such as the erythrovirus B19 (B19V) and the anellovirus torquetenovirus (TTV). This study has been performed to assess the effect of the HSA purification procedures on the viral contamination. STUDY DESIGN AND METHODS: Known concentrations of B19V and TTV virus were spiked in raw Fraction V, the starting material from fractionated human plasma for HSA purification, which was subsequently submitted to the depth filtration procedure. After spiking, B19V and TTV genome copies were determined by real-time quantitative polymerase chain reaction assays in the mixture at the end of Fraction V dissolution, to determine the virus concentration achieved, in the HSA solution after the filtration step, in the filtered postwashing fluid, and in the supernatant of resuspended Celite. RESULTS: B19V was completely adsorbed by the Celite used as a filter aid in the depth filtration process and was thus undetectable in the resulting HSA-containing fraction. In contrast, in 2 out of 3 experiments, TTV was detected in all samples. CONCLUSION: The different behavior of the two viruses might be a reflection of their different surface charge.