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Abstract A holistic approach was taken to characterise lyophilisers at both laboratory and commercial scale to design a focused validation strategy for commercialising parenteral drug products. Vial heat transfer coefficients (Kv) and equipment mass transfer boundaries were generated for a Lyostar II and three commercial scale IMA Lyomax lyophilisers. K v studies were performed using gravimetric methodologies. K v calculated for the Lyostar II was equivalent to the commercial equipment at 133 µBar however trended higher below 133 µBar and lower above 133 µBar potentially impacting primary drying product temperature during scale-up depending on the chamber pressure recipe set point. Kv profiles were consistent within and across the commercial equipment. Edge effect was most prominent at commercial scale with minimal shielding of the edge vials in contrast to the presence of a metal ring around the vial pack in the Lyostar II. Equipment capability studies for mass transfer showed commercial scale equipment could achieve lower chamber pressure and greater sublimation rates when compared to the Lyostar II. Furthermore, differences were also measured between large-scale lyophilisers based on condenser orientation (horizontal vs vertical). The results demonstrate greater equipment capability of the two-storey vertical configuration with respect to choked flow regime. Worst-case locations within a commercial lyophiliser were identified providing rationale for reduced sampling for product shelf-mapping locations. This work provides guidance on execution of commercial scale characterisation studies and application of the data to enhance scale-up, technical transfer and focused process validation strategies.

A holistic approach was taken to characterise lyophilisers at both laboratory and commercial scale to design a focused validation strategy for commercialising parenteral drug products. Vial heat transfer coefficients (Kv) and equipment mass transfer boundaries were generated for a Lyostar II and three commercial scale IMA Lyomax lyophilisers. Kv studies were performed using gravimetric methodologies. Kv calculated for the Lyostar II was equivalent to the commercial equipment at 133 µBar however trended higher below 133 µBar and lower above 133 µBar potentially impacting primary drying product temperature during scale-up depending on the chamber pressure recipe set point. Kv profiles were consistent within and across the commercial equipment. Edge effect was most prominent at commercial scale with minimal shielding of the edge vials in contrast to the presence of a metal ring around the vial pack in the Lyostar II. Equipment capability studies for mass transfer showed commercial scale equipment could achieve lower chamber pressure and greater sublimation rates when compared to the Lyostar II. Furthermore, differences were also measured between large-scale lyophilisers based on condenser orientation (horizontal vs vertical). The results demonstrate greater equipment capability of the two-storey vertical configuration with respect to choked flow regime. Worst-case locations within a commercial lyophiliser were identified providing rationale for reduced sampling for product shelf-mapping locations. This work provides guidance on execution of commercial scale characterisation studies and application of the data to enhance scale-up, technical transfer and focused process validation strategies. [ABSTRACT FROM AUTHOR]

Livestock producers' operational perspectives and characteristics are known to be associated with silvopasture adoption, but findings in the literature are mixed and contradictory. To study whether characteristics or perspectives more closely relate to silvopasture interest, 307 livestock producers enrolled in cost-share programs in Virginia, United States of America were surveyed. One hundred and thirty-nine producers responded (rate = 45%). Interest in silvopasture was measured using a Likert-type ordinal scale. Respondents reported the following operational characteristics: size in hectares, type and number of livestock, and primary or secondary occupation. Twelve Likert-type ordinal scales were used to measure the following operational perspectives: financial emphasis, cultural importance, and attitudes pertaining to operational diversification using trees. Multivariate cluster methods were used to group respondents into two classification sets, one based on operational characteristics and the other operational perspectives. Tests for significant differences in silvopasture interest between classifications in each set were conducted using non-parametric Kruskal–Wallis rank sums (α = 0.05). Silvopasture interest differed significantly among classifications based on operational perspectives, but not operational characteristics. Cross-tabulations of the two sets and Cramer's V test indicated that the two classification sets are unrelated. Findings suggest silvopasture interest cuts across operation type and is more closely tied to producers' perspectives, particularly views related to diversification. Technical transfer programs and stakeholder engagement should focus on matching perspectives to practice regardless of operational scale and scope. [ABSTRACT FROM AUTHOR]

Solid organ transplantation is the treatment of choice for patients with end-stage organ dysfunction. Despite improvements in short-term outcome, long-term outcome is suboptimal due to the increased morbidity and mortality associated with the toxicity of immunosuppressive regimens and chronic rejection (1–5). As such, the attention of the transplant community has focused on the development of novel therapeutic strategies to achieve allograft tolerance, a state whereby the immune system of the recipient can be re-educated to accept the allograft, averting the need for long-term immunosuppression. Indeed, reports of “operational” tolerance, whereby the recipient is off all immunosuppressive drugs and maintaining good graft function, is well documented in the literature for both liver and kidney transplantations (6–8). However, this phenomenon is rare and in the setting of liver transplantation has been shown to occur late after transplantation, with the majority of patients maintained on life-long immunosupression to prevent allograft rejection (9). As such, significant research has focused on immune regulation in the context of organ transplantation with regulatory T cells (Tregs) identified as cells holding considerable promise in this endeavor. This review will provide a brief introduction to human Tregs, their phenotypic and functional characterization and focuses on our experience to date at the clinical translation of Treg immunotherapy in the setting of solid organ transplantation.

Defensive architecture in Southeast Asian port cities during the eighteenth century is a topic never addressed from a transnational perspective. This paper aims to analyze it as a phenomenon of scientific transfer, considering fortifications as a remarkable example of "open air science." First, it shows the complex situation among antagonistic powers in the Malay and South China seas. From here, it aims to identify the connections between Dutch and Spanish proposals in the area. One model focused on protecting sea routes, while the other was more concerned about maintaining territorial integrity. Later, it considers how local kingdoms from China or Siam to the southern sultanates addressed the problem. Here, a variety of answers have been found, ranging from a complete rejection of European solutions to qualified adaptations and wholesale adoption of them. From all these examples, it is possible to evaluate the nature of technical transfer in a transnational perspective. [ABSTRACT FROM AUTHOR]

The degradation of biodiversity caused by anthropic habitat destruction is a global issue. The recovery of natural habitats from invasive alien weeds in order to conserve endemic ecosystems is especially important on small oceanic islands. Planting of endemic trees may be an effective measure, but a complete restoration process within the island is essential to avoid accidental introduction of invasive aliens. To test planting techniques, we planted two endemic tree species whose regeneration was hindered by alien species on degraded lands on Chichi-jima (Ogasawara Islands) and monitored vegetation changes. During an 11-year period, about half of the Elaeocarpus photiniifolius seedlings survived in gap areas, but all Morus boninensis failed. The E. photiniifolius trees reached a height of 4.7 ± 2.4 m. The restored canopy created a dark environment that greatly reduced the volume of the predominant invasive weeds. These results suggest that E. photiniifolius is suitable for restoration of forests on degraded land and for the suppression of weeds on the island. Low species diversity in the restored forests, however, was a remaining issue to be addressed. Herein we discuss potential improvement measures to facilitate the recovery of species diversity, including other native tree candidates. [ABSTRACT FROM AUTHOR]

Abstract: Despite being at the heart of the question of the emergence of the European Upper Palaeolithic, the Aurignacian osseous industry is essentially known by the production of split-based points, ornaments and portable art whereas bone tools, usually dedicated to domestic tasks and with variable technical complexity, have been largely ignored. However, when the high number of unworked tools is included – i.e. bone fragments recovered from food processing and used directly as tools with no previous shaping phase – bone tools represent a significant proportion of the Early Aurignacian industry. Among these unworked tools, is a newly-discovered type: “unworked intermediate tools.” This article presents a detailed description based on taphonomic, typological and technological characters. It shows that these tools are diaphyseal fragments which are used directly as a wedge, very likely for woodworking and perhaps for antler processing. The processes behind the appearance of osseous technology at the beginning of the Upper Palaeolithic in Europe are then discussed in light of this discovery and, more generally, the revised composition of the Early Aurignacian toolkit. The high proportion of unworked bone tools, a type more commonly associated with the Middle Palaeolithic, suggests a more gradual technological shift between Middle and Upper Palaeolithic than has previously been considered. As part of this hypothesis, the emergence of working osseous material could be due to a gradual transfer of techniques previously applied to wood, as others have proposed. [Copyright &y& Elsevier]

At the end of the ninetenth century, Buenos Aires was an attractive pole for European migrants. In those years, the city appears as a perpetual worksite which gathered many architects, engineers and builders born on the other side of the Atlantic. If Buenos Aires is often called “Southern Paris”—because of the haussmannization process engaged by the mayor Torcuato de Alvear in the 1880s—the architectural forms of the city highlight the role of cultural and technical transfers in the buildings’ design. A close attention to the building process helps us understand how much the local reception of European canons gave way to improvisation and appropriation, underlining the constant tension between a supposed “model” of urbanization and his Argentine interpretation. Paying attention to the evolution of Buenos Aires houses, it can be shown that the introduction of every new stylistic or technical element is a compromise between the “European modernity” and the vernacular building art. Moreover, understanding the connection between the Argentine building market and the European professionals, such as the architects and engineers, seems decisive. Paying particular attention to Franco-Argentine relations in this sector leads one to realize the importance of the networks between diplomatic, financial and architectural circles. If the Argentine building market can appear as a commercial opportunity for French contractors, we have to mention the “inverse transfers” which allow foreign engineers and architects to benefit of their Argentine experience in their posterior projects and realisations. Thus, the building sector of Buenos Aires not only was a fruitful testing ground for European architectural theories, but also is a case par excellence to enrich our understanding of the debates and interchanges of French and Argentine professionals.