The sociocultural dimension of the Software Process Improvement manifesto: pilot validation by experts

The SPI Manifesto is based on three basic values: people, business focus, and organizational change underpinning the philosophy of Software Process Improvement (SPI). In turn, these values bring up to date certain SPI principles serving as a foundation for action in software development. The authors of this paper carried out a pilot expert validation of the Sociocultural dimension of the STEEPLED (Sociocultural, Technical, Economic, Environmental, Political, Legal, Ethical and Demographic) analysis of the SPI Manifesto. Further, the authors report on the rationale and results of the pilot validation of both the survey instrument and the qualitative responses generated by the field experts, targeting to enlighten and reinforce the importance of the Sociocultural dimension of the SPI Manifesto in research and development. The related literature review findings and the pilot research study strengthen this target. The pilot study with experts in particular provided stronger indications that the Sociocultural dimension is considered of high importance by between 62% and 88% of the respondents, who were IT and Computing professionals and software practitioners from academia and industry

Towards a multidimensional self-assessment for software process improvement: a pilot tool

The SPI Manifesto provides a framework for guiding software development organisations in their improvement efforts. Based on the Values of People, Business and Change, which are supported and informed by one or more of the ten principles, the designer and developer can avoid pitfalls, minimise risks and make their business successful. It has been established, in theory and practice, that improving the process results in improvement of the products and services emanating from that process. Following a number of earlier multidimensional analyses of the SPI Manifesto, carried out by the authors, a series of tabular representations identifying the nature, importance and strength of relationships between the Manifesto’s Values and Principles in terms of eight dimensions encapsulated in the acronym STEEPLED (Sociocultural, Technical, Economic, Environmental, Political, Legal, Ethical and Demographic) were developed. In this paper, we present a conceptualisation of a pilot automated tool (based on the STEEPLED Analysis), which could, potentially, be implemented/realised and used for self-assessment by software developing organisations. Starting with a self-assessment, current issues and requirements could be identified and revealed. The self-assessment using the pilot automated tool would, additionally, reveal areas requiring improvement, and would serve as a guide for the participating organisation to put focus on prioritising candidate process areas that require improvement. Also, the field testing of the pilot tool could enable the design and improvement of the tool itself, which, in turn, will be used in future for expert external/independent process assessment

Melanin-concentrating hormone and its receptor are expressed and functional in human skin

In this study, we have demonstrated the presence of melanin-concentrating hormone (MCH) and melanin-concentrating hormone receptor (MCHR1) transcripts in human skin. Sequence analysis confirmed that the transcripts of both genes were identical to those previously found in human brain. In culture, endothelial cells showed pro-MCH expression whereas no signal was found in keratinocytes, melanocytes, and fibroblasts. MCHR1 expression was restricted to melanocytes and melanoma cells. Stimulation of cultured human melanocytes with MCH reduced the α-MSH-induced increase in cAMP production. Furthermore, the melanogenic actions of α-MSH were inhibited by MCH. We propose that the MCH/MCHR1 signalling system is present in human skin and may have a role with the melanocortins in regulating the melanocyte

A multidimensional review and extension of the SPI Manifesto using STEEPLED analysis: an expert validation

Over a decade has passed since the inception of the SPI Manifesto. The fact that the signatories of the manifesto emanate from both the academic and the industrial communities enables a robust exchange of ideas and experiences. Continuous enrichment and refinement have been evidenced in publications, industrial projects, and consultancy across both communities. The main publication fora of this cross-disciplinary collaboration have been the EuroAsiaSPI conferences, which have stimulated the healthy evolution of innovative ideas and disciplinary action(s). There is a current debate aiming to review and update the SPI Manifesto after ten years of theory and practice whilst major trends and practices gained ground. This study aims to validate the multidimensional STEEPLED (Sociocultural, Technical, Economic, Environmental, Political, Legal, Ethical, and Demographic) analysis of the SPI Manifesto, and to contribute to-wards a formal review and upgrade of the SPI Manifesto. The study targets the strengthening of the dimensions which are absent, mentioned, or implied, but are not explicitly specified in the SPI Manifesto. The experts are academics and practitioners or both, all with a strong track record in the SPI movement. The authors are also academics and/or practitioners and include some of the original developers/signatories of the SPI Manifesto. This paper concludes with concrete suggestions for the update, extension, and re-launch of the SPI Manifesto and proposals for the formulation of strategies for guiding SPI

Hybrid Mass Spectrometry Methods Reveal Lot-to-Lot Differences and Delineate the Effects of Glycosylation on the Structure of Herceptin®

To consider the measurable variations in biopharmaceuticals we use mass spectrometry and systematically evaluate three lots of Herceptin®, two mAb standards and an intact Fc-hinge fragment. Each mAb is examined in three states; glycan intact, truncated (following endoS2 treatment) and fully deglycosylated. Despite equivalence at the protein level, each lot of Herceptin® gives a distinctive signature in three different mass spectrometry analyses. Ion mobility mass spectrometry (IM-MS) shows that in the API, the attached N-glycans reduce the conformational spread of each mAb by 10.5 – 25 %. Hydrogen/deuterium exchange mass spectrometry (HDX-MS) data supports this, with lower global deuterium uptake in solution when comparing intact to the fully deglycosylated protein. HDX-MS and activated IM-MS map the influence of glycans on the mAb and reveal allosteric effects which extend far beyond the Fc domains into the Fab region. Taken together these findings, and the supplied interactive data sets could be used to provide acceptance criteria with application for MS based characterisation of biosimilars and novel therapeutic mAbs. </p

Hybrid Mass Spectrometry Methods Reveal Lot-to-Lot Differences and Delineate the Effects of Glycosylation on the Structure of Herceptin®

<p>To consider the measurable variations in biopharmaceuticals we use mass spectrometry and systematically evaluate three lots of Herceptin®, two mAb standards and an intact Fc-hinge fragment. Each mAb is examined in three states; glycan intact, truncated (following endoS2 treatment) and fully deglycosylated. Despite equivalence at the protein level, each lot of Herceptin® gives a distinctive signature in three different mass spectrometry analyses. Ion mobility mass spectrometry (IM-MS) shows that in the API, the attached N-glycans reduce the conformational spread of each mAb by 10.5 – 25 %. Hydrogen/deuterium exchange mass spectrometry (HDX-MS) data supports this, with lower global deuterium uptake in solution when comparing intact to the fully deglycosylated protein. HDX-MS and activated IM-MS map the influence of glycans on the mAb and reveal allosteric effects which extend far beyond the Fc domains into the Fab region. Taken together these findings, and the supplied interactive data sets could be used to provide acceptance criteria with application for MS based characterisation of biosimilars and novel therapeutic mAbs. </p

Prostaglandin production by melanocytic cells and the effect of a-melanocyte stimulating hormone

NoProstaglandins are potent mediators of the inflam-matory response and are also involved in cancer development. In this study, we show that human melanocytes and FM55 melanoma cells express cyclooxygenase-1 and -2 (COX-1 and-2) and thus have the capability to produce prostaglandins. TheFM55 cells produced predominantly PGE2and PGF2a, whereas the HaCaT keratinocyte cell line produced mainly PGE2. The anti-inflammatory peptide, a-melanocyte stimulating hormone(a-MSH), reduced prostaglandin production in FM55 and HaCaT cells and reversed the effect of the pro-inflammatory cytokine TNF-a in the former. These results indicate that melanocytes produce prostaglandins and that a-MSH, by inhibiting this response, may play an important role in regulating inflammatory responses in the skin