Microneedle characterisation: the need for universal acceptance criteria and GMP specifications when moving towards commercialisation

With interest in microneedles as a novel drug transdermal delivery system increasing rapidly since the late 1990s (Margetts and Sawyer Contin Educ Anaesthesia Crit Care Pain. 7(5):171-76, 2007), a diverse range of microneedle systems have been fabricated with varying designs and dimensions. However, there are still very few commercially available microneedle products. One major issue regarding microneedle manufacture on an industrial scale is the lack of specific quality standards for this novel dosage form in the context of Good Manufacturing Practice (GMP). A range of mechanical characterisation tests and microneedle insertion analysis techniques are used by researchers working on microneedle systems to assess the safety and performance profiles of their various designs. The lack of standardised tests and equipment used to demonstrate microneedle mechanical properties and insertion capability makes it difficult to directly compare the in use performance of candidate systems. This review highlights the mechanical tests and insertion analytical techniques used by various groups to characterise microneedles. This in turn exposes the urgent need for consistency across the range of microneedle systems in order to promote innovation and the successful commercialisation of microneedle products.

Seaborne trade and the commercialisation of fifteenth- and sixteenth-century Gaelic Ulster

This study considers the frequently stated claim that the economy of Gaelic- speaking lordships in Ulster during the fifteenth and sixteenth centuries was predominately pastoral anduncommercialised, by drawing on a variety of sources not usually combined. It proposes that the increased European demand for fish and the growth of the fish industry across northern Europe played a crucial role in stimulating trade between the coastal areas of Ulster on the one hand, and Britain and continental Europe on the other. This led to the establishment of permanent markets and towns, which joined at least two new inland towns in the southern parts of the province, bringing about a commercial presence in most of the Ulster lordships before 1600. Gaelic Lords consolidated this development by building castles and friaries at these fixed trading places.

Understanding Quadruple Helix Relationships of University Technology Commercialisation: A Micro Level Approach

Given recent demands for more co-creational university technology commercialisation
processes involving industry and end users, this paper adopts a micro level approach to explore
the challenges faced by universities when managing quadruple helix stakeholders within the
technology commercialisation processes. To explore this research question, a qualitative
research methodology which relies upon comparative case analysis was adopted to explore the
technology commercialisation process in two universities within a UK region. The findings
revealed that university type impacts Quadruple Helix stakeholder salience and engagement
and consequently university technology commercialisation activities and process. This is
important as recent European regional policy fails to account for contextual influences when
promoting Quadruple Helix stakeholder relationships in co-creational university technology
commercialisation.

Investment and Capitalization of Firms in the USA

In the USA today, the precipitous rise of new financial mechanisms for capitalisation of firms as well as the merger and acquisition of others, especially risk equity capital through venture capitalist and investment banking, has sparked growth and helped to bring the economy out of the 1990s recession into a robust continuous growth pattern well positioned for the next century. The scenario is not new. For the venture capitalists of ''Silicon Valley'' in California, the experience is not new. They have seen the new industries arise before, like a phoenix from ashes of ruin, despair and even failure. Venture capital poured into high tech start-up companies has been an enormous source of financial support for the entrepreneurs who head new and growing companies. The mid-1990s marked the most dramatic increase yet recorded. Indicators, such as the NASDAQ document, outlined the solid and continuous growth in high tech industries. The paper discusses investment in US corporations within the context of governance and management of the company. Discussion about the various forms of finance are related to the organisation and management of the US corporation. Critical to any firm today are its ability to find innovative, new products or services. A growing literature on resource-base framework for analysis will be discussed as part of the firm's development of research for commercialisation. The results of a recent survey further shed light on the relationship between corporate financial management and allocated resources for research and development as the ''engine'' for new product development and therefore corporate market share and growth. The conclusion is that more financial mechanisms will be created and changed within US corporate systems to adjust, grow, and expand companies in the global economic arena, as the inevitable economic pattern leads to mergers, consolidations, and increasing cooperation and alliances among firms.

An exploratory study of Principal Investigator roles in UK University Proof-of-Concept processes: an Absorptive capacity perspective

The increasing emphasis on academic entrepreneurship, technology transfer and research commercialisation within UK universities is predicated on basic research being developed by academics into commercial entities such as university spin-off companies or licensing arrangements. However, this process is fraught with challenges and risks, given the degree of uncertainty regarding future returns. In an attempt to minimise such risks, the Proof-of-Concept (PoC) process has been developed within University Science Park Incubators (USIs) to test the technological, business and market potential of embryonic technology. The key or the pivotal stakeholder within the PoC is the Principal Investigator (PI), who is usually the lead academic responsible for the embryonic technology. Within the current literature, there appears to be a lack of research pertaining to the role of the PI in the PoC process. Moreover, Absorptive Capacity (ACAP) has emerged within the literature as a theoretical framework or lens for exploring the development and application of new knowledge and technology, where the USI is the organisation considered in the current study. Therefore, the aim of this paper is to explore the role and influence of the PI in the PoC process within a USI setting using an ACAP perspective. The research involved a multiple case analysis of PoC applications within a UK university USI. The results demonstrate the role of the PI in developing practices and routines within the PoC process. These practices and processes were initially tacit and informal in nature but became more explicit and formal over time so that knowledge was retained within the USI after the PIs had completed the PoC process. © 2010 The Authors. R&D Management © 2010 Blackwell Publishing Ltd.

Structural Capital of University Spin-Out Firms: The Moderating Role of University Incubators

University incubators (UI) are generally believed to be important in the successful commercialisation of university spin-outs (USO) with over half of all UK Universities having established an on-campus UI. In this chapter we examine the value of UIs in the spin-out process, focusing on the structural networks of USOs located in a UI as compared to USOs in a University with no access to a UI. Our primary research question is therefore: to what extent does the structural network of USOs with access to an on-campus UI differ from USOs without? The research therefore con-tributes to a growing critique of the effectiveness of UIs in commercialis-ing academic research and the recognition of positive direct and indirect externalities from participation in networks. Through network mapping of all USOs from two research intensive universities, we profile and ana-lyse the formal and informal network ties of USOs to various partners in-ternal and external to the host university. Through interviews we also consider how these networks enhance the resources and capabilities of USOs. Our findings highlight significant differences, with USOs located in a UI having more informal but fewer formal ties, both to other USOs as well as within the host University. In contrast, location in an incuba-tor was not found to affect the extent and nature of ties with external or-ganisations. Reasons for these differences are examined through inter-views with the USOs and point to various factors including the proactive brokering role of incubator and university staff, university bureaucracy, the hidden networks of executive board members across USOs, university equity investment policy and complementary technologies.

Fasciola hepatica vaccine: We may not be there yet but we're on the right road

Major advances have been made in identifying potential vaccine molecules for the control of fasciolosis in livestock but we have yet to reach the level of efficacy required for commercialisation. The pathogenesis of fasciolosis is associated with liver damage that is inflicted by migrating and feeding immature flukes as well as host inflammatory immune responses to parasite-secreted molecules and tissue damage alarm signals. Immune suppression/modulation by the parasites prevents the development of protective immune responses as evidenced by the lack of immunity observed in naturally and experimentally infected animals. In our opinion, future efforts need to focus on understanding how parasites invade and penetrate the tissues of their hosts and how they potentiate and control the ensuing immune responses, particularly in the first days of infection. Emerging 'omics' data employed in an unbiased approach are helping us understand liver fluke biology and, in parallel with new immunological data, to identify molecules that are essential to parasite development and accessible to vaccine-induced immune responses.

Computational scheduling methods for integrating plug-in electric vehicles with power systems: a review

Traditional internal combustion engine vehicles are a major contributor to global greenhouse gas emissions and other air pollutants, such as particulate matter and nitrogen oxides. If the tail pipe point emissions could be managed centrally without reducing the commercial and personal user functionalities, then one of the most attractive solutions for achieving a significant reduction of emissions in the transport sector would be the mass deployment of electric vehicles. Though electric vehicle sales are still hindered by battery performance, cost and a few other technological bottlenecks, focused commercialisation and support from government policies are encouraging large scale electric vehicle adoptions. The mass proliferation of plug-in electric vehicles is likely to bring a significant additional electric load onto the grid creating a highly complex operational problem for power system operators. Electric vehicle batteries also have the ability to act as energy storage points on the distribution system. This double charge and storage impact of many uncontrollable small kW loads, as consumers will want maximum flexibility, on a distribution system which was originally not designed for such operations has the potential to be detrimental to grid balancing. Intelligent scheduling methods if established correctly could smoothly integrate electric vehicles onto the grid. Intelligent scheduling methods will help to avoid cycling of large combustion plants, using expensive fossil fuel peaking plant, match renewable generation to electric vehicle charging and not overload the distribution system causing a reduction in power quality. In this paper, a state-of-the-art review of scheduling methods to integrate plug-in electric vehicles are reviewed, examined and categorised based on their computational techniques. Thus, in addition to various existing approaches covering analytical scheduling, conventional optimisation methods (e.g. linear, non-linear mixed integer programming and dynamic programming), and game theory, meta-heuristic algorithms including genetic algorithm and particle swarm optimisation, are all comprehensively surveyed, offering a systematic reference for grid scheduling considering intelligent electric vehicle integration.

Activity and coke formation of nickel and nickel carbide in dry reforming: A deactivation scheme from density functional theory

Dry reforming is a promising reaction to utilise the greenhouse gases CO2 and CH4. Nickel-based catalysts are the most popular catalysts for the reaction, and the coke formation on the catalysts is the main obstacle to the commercialisation of dry reforming. In this study, the whole reaction network of dry reformation on both flat and stepped nickel catalysts (Ni(111) and Ni(211)) as well as nickel carbide (flat: Ni3C(001); stepped: Ni3C(111)) is investigated using density functional theory calculations. The overall reaction energy profiles in the free energy landscape are obtained, and kinetic analyses are utilised to evaluate the activity of the four surfaces. By careful examination of our results, we find the following regarding the activity: (i) flat surfaces are more active than stepped surfaces for the dry reforming and (ii) metallic nickel catalysts are more active than those of nickel carbide, and therefore, the phase transformation from nickel to nickel carbide will reduce the activity. With respect to the coke formation, the following is found: (i) the coke formation probability can be measured by the rate ratio of CH oxidation pathway to C oxidation pathway (r(CH)/r(C)) and the barrier of CO dissociation, (ii) on Ni(111), the coke is unlikely to form, and (iii) the coke formations on the stepped surfaces of both nickel and nickel carbide can readily occur. A deactivation scheme, using which experimental results can be rationalised, is proposed. 

Reductive photocatalysis and smart inks

Semiconductor-sensitised photocatalysis is a well-established and growing area of research, innovation and commercialisation; the latter being mostly limited to the use of TiO2 as the semiconductor. Most of the work on semiconductor photocatalytic systems uses oxygen as the electron acceptor and explores a wide range of electron donors; such systems can be considered to be examples of oxidative photocatalysis, OP. OP underpins most current examples of commercial self-cleaning materials, such as: glass, tiles, concrete, paint and fabrics. OP, and its myriad of applications, have been reviewed extensively over the years both in this journal and elsewhere. However, the ability of TiO2, and other semiconductor sensitisers, to promote reductive photocatalysis, RP, especially of dyes, is significant and, although less well-known, is of growing importance. In such systems, the source of the electrons is some easily oxidised species, such as glycerol. One recent, significant example of a RP process is with respect to photocatalyst activity indicator inks. paiis, which provide a measure of the activity of a photocatalytic film under test via the rate of change of colour of the dye in the ink coating due to irreversible RP. In contrast, by incorporating the semiconductor sensitiser in the ink, rather than outside it, it is possible to create an effective UV dosimeter, based on RP, which can be used as a sun-burn warning indicator. In the above examples the dye is reduced irreversibly, but when the photocatalyst in an ink is used to reversibly photoreduce a dye, a novel, colourimetric oxygen-sensitive indicator ink can be created, which has commercial potential in the food packaging industry. Finally, if no dye is present in the ink, and the semiconductor photocatalyst-loaded ink film coats an easily reduced substrate, such as a metal oxide film, then it can be used to reduce the latter and so, for example, clean up tarnished steel. The above are examples of smart inks, i.e. inks that are active and provide either dynamic information (such as UV dose or O2 level) or a useful function (such as tarnish removal), and all work via a RP process and are reviewed here

Microneedle applications in improving skin appearance

Microneedles (MNs) are micron-sized, minimally invasive devices that breach the outermost layer of the skin, the stratum corneum (SC), creating transient, aqueous pores in the skin and facilitating the transport of therapeutic molecules into the epidermis. Following many years of extensive research in the area of MN-mediated trans- and intra-dermal drug delivery, MNs are now being exploited in the cosmeceutical industry as a means of disrupting skin cell architecture, inducing elastin and collagen expression and deposition. They are also being used as vehicles to deliver cosmeceutic molecules across the skin, in addition to their use in combinatorial treatments with topical agents or light sources. This review explores the chronology of microneedling methodologies, which has led to the emergence of MN devices, now extensively used in cosmeceutical applications. Recent developments in therapeutic molecule and peptide delivery to the skin via MN platforms are addressed and some commercially available MN devices are described. Important safety and regulatory considerations relating to MN usage are addressed, as are studies relating to public perception of MN, as these will undoubtedly influence the acceptance of MN products as they progress towards commercialisation.