Efforts towards adaptability enhancement:how manufacturing and service industries can learn from each other

This paper discusses the recent emerging efforts for adaptability enhancement of Japanese industries to cope with a volatile demand environment. It is based on an analysis of data obtained from respondent companies. The analysis is focused on both manufacturing and manufacturing- related service industries such as construction/maintenance, software supply, manufacturing consultation and logistics industries to highlight their current situation, the sense of crisis in Japanese companies and possible future directions in relation to the two industry sectors. The principal conclusion is that for most companies consideration of a revision or modification to its cost structure is an essential requirement for survival in the global competitive environment.

Servitization of manufacture:exploring the deployment and skills of people critical to the delivery of advanced services

Purpose - This "research note" sets out to fuel the debate around the practices and technologies within operations that are critical to success with servitization. It presents a study of four companies which are delivering advanced services and reports on the organisation and skill-sets of people within these. Design/methodology/approach - This has been case-based research at four manufacturers leading in their delivery of services. Findings - It describes the desirable behaviour of people in the front-line of service delivery, identifies the supporting skill-sets, how these people are organised, and explains why all these factors are so important. Originality/value - This paper contributes to the understanding of the servitization process and, in particular, the implications to broader operations of the firm. © 2013 Emerald Group Publishing Limited. All rights reserved.

Challenges and emerging solutions in the development of compressed orally disintegrating tablets

Areas covered: The review discusses the main challenges of ODT manufacturing process and the emerging solutions featured at early drug development stages. The research specifically describes the methods reported for taste masking/assessment and solubilisation of unpalatable and poorly soluble drugs, respectively. Furthermore, this review highlights the techniques used for developing modified-release ODTs, an emerging area in the field. In addition, it also discusses the poor flowability and segregation problems of directly compressed powders. Moreover, the review describes the tests reported in the literature for ODT disintegration time assessment since a universal technique is still non-existent. Expert opinion: The approaches used to overcome the manufacturing challenges often have a bearing on the price of the end product. However, despite the technical and regulatory challenges, ODTs can offer many advantages over the conventional dosage forms if accompanied by suitable adjuvant technologies and in vitro analytical tools. © 2014 Informa UK, Ltd. Introduction: Orally disintegrating tablets (ODTs) provide several advantages over conventional tablets such as suitability for patients with swallowing difficulties and faster onset of action. The manufacture of ODTs by compression/tableting offers a practical and cost-effective strategy over the freeze drying (lyophilisation) method. Nonetheless, the FDA recommends a disintegration time of 30 s and a maximum weight of 500 mg for a tablet to be labelled as an ODT. These requirements, alongside other desirable product properties, have created a number of challenges for the formulator to overcome while developing compressed ODTs.

Systematic financial resources allocation processes:a model for critical resources mobilization and deployment for nigerian universities

Purpose – The purpose of this research is to study the perceived impact of some factors on the resources allocation processes of the Nigerian universities and to suggest a framework that will help practitioners and academics to understand and improve such processes. Design/methodology/approach – The study adopted the interpretive qualitative approach aimed at an ‘in-depth’ understanding of the resource allocation experiences of key university personnel and their perceived impact of the contextual factors affecting such processes. The analysis of individual narratives from each university established the conditions and factors impacting the resources allocation processes within each institution. Findings – The resources allocation process issues in the Nigerian universities may be categorised into people (core and peripheral units’ challenge, and politics and power); process (resources allocation processes); and resources (critical financial shortage and resources dependence response). The study also provides insight that resourcing efficiency in Nigerian universities appears strongly constrained by the rivalry among the resource managers. The efficient resources allocation process (ERAP) model is proposed to resolve the identified resourcing deficiencies. Research limitations/implications – The research is not focused to provide generalizable observations but ‘in-depth’ perceived factors and their impact on the resources allocation processes in Nigerian universities. The study is limited to the internal resources allocation issues within the universities and excludes the external funding factors. The resource managers’ responses to the identified factors may affect their internal resourcing efficiency. Further research using more empirical samples is required to obtain more widespread results and the implications for all universities. Originality/value – This study contributes a fresh literature framework to resources allocation processes focusing at ‘people’, ‘process’ and ‘resources’. Also a middle range theory triangulation is developed in relation to better understanding of resourcing process management. The study will be of interest to university managers and policy makers.

Expansion, harvest and cryopreservation of human mesenchymal stem cells in a serum-free microcarrier process

Human mesenchymal stem cell (hMSC) therapies are currently progressing through clinical development, driving the need for consistent, and cost effective manufacturing processes to meet the lot-sizes required for commercial production. The use of animal-derived serum is common in hMSC culture but has many drawbacks such as limited supply, lot-to-lot variability, increased regulatory burden, possibility of pathogen transmission, and reduced scope for process optimization. These constraints may impact the development of a consistent large-scale process and therefore must be addressed. The aim of this work was therefore to run a pilot study in the systematic development of serum-free hMSC manufacturing process. Human bone-marrow derived hMSCs were expanded on fibronectin-coated, non-porous plastic microcarriers in 100mL stirred spinner flasks at a density of 3×10⁵cells.mL^-1 in serum-free medium. The hMSCs were successfully harvested by our recently-developed technique using animal-free enzymatic cell detachment accompanied by agitation followed by filtration to separate the hMSCs from microcarriers, with a post-harvest viability of 99.63±0.03%. The hMSCs were found to be in accordance with the ISCT characterization criteria and maintained hMSC outgrowth and colony-forming potential. The hMSCs were held in suspension post-harvest to simulate a typical pooling time for a scaled expansion process and cryopreserved in a serum-free vehicle solution using a controlled-rate freezing process. Post-thaw viability was 75.8±1.4% with a similar 3h attachment efficiency also observed, indicating successful hMSC recovery, and attachment. This approach therefore demonstrates that once an hMSC line and appropriate medium have been selected for production, multiple unit operations can be integrated to generate an animal component-free hMSC production process from expansion through to cryopreservation.

Enhancing the performance of intelligent control systems in the face of higher levels of complexity and uncertainty

Modern advances in technology have led to more complex manufacturing processes whose success centres on the ability to control these processes with a very high level of accuracy. Plant complexity inevitably leads to poor models that exhibit a high degree of parametric or functional uncertainty. The situation becomes even more complex if the plant to be controlled is characterised by a multivalued function or even if it exhibits a number of modes of behaviour during its operation. Since an intelligent controller is expected to operate and guarantee the best performance where complexity and uncertainty coexist and interact, control engineers and theorists have recently developed new control techniques under the framework of intelligent control to enhance the performance of the controller for more complex and uncertain plants. These techniques are based on incorporating model uncertainty. The newly developed control algorithms for incorporating model uncertainty are proven to give more accurate control results under uncertain conditions. In this paper, we survey some approaches that appear to be promising for enhancing the performance of intelligent control systems in the face of higher levels of complexity and uncertainty.

Characterization of human mesenchymal stem cells from multiple donors and the implications for large scale bioprocess development

Cell-based therapies have the potential to contribute to global healthcare, whereby the use of living cells and tissues can be used as medicinal therapies. Despite this potential, many challenges remain before the full value of this emerging field can be realized. The characterization of input material for cell-based therapy bioprocesses from multiple donors is necessary to identify and understand the potential implications of input variation on process development. In this work, we have characterized bone marrow derived human mesenchymal stem cells (BM-hMSCs) from multiple donors and discussed the implications of the measurable input variation on the development of autologous and allogeneic cell-based therapy manufacturing processes. The range of cumulative population doublings across the five BM-hMSC lines over 30 days of culture was 5.93, with an 18.2% range in colony forming efficiency at the end of the culture process and a 55.1% difference in the production of interleukin-6 between these cell lines. It has been demonstrated that this variation results in a range in the process time between these donor hMSC lines for a hypothetical product of over 13 days, creating potential batch timing issues when manufacturing products from multiple patients. All BM-hMSC donor lines demonstrated conformity to the ISCT criteria but showed a difference in cell morphology. Metabolite analysis showed that hMSCs from the different donors have a range in glucose consumption of 26.98 pmol cell−1 day−1, Lactate production of 29.45 pmol cell−1 day−1 and ammonium production of 1.35 pmol cell−1 day−1, demonstrating the extent of donor variability throughout the expansion process. Measuring informative product attributes during process development will facilitate progress towards consistent manufacturing processes, a critical step in the translation cell-based therapies.

The challenges of representing human behaviour in simulation models:some case examples from supply chain, evacuation modelling and rail disruption

As more of the economy moves from traditional manufacturing to the service sector, the nature of work is becoming less tangible and thus, the representation of human behaviour in models is becoming more important. Representing human behaviour and decision making in models is challenging, both in terms of capturing the essence of the processes, and also the way that those behaviours and decisions are or can be represented in the models themselves. In order to advance understanding in this area, a useful first step is to evaluate and start to classify the various types of behaviour and decision making that are required to be modelled. This talk will attempt to set out and provide an initial classification of the different types of behaviour and decision making that a modeller might want to represent in a model. Then, it will be useful to start to assess the main methods of simulation in terms of their capability in representing these various aspects. The three main simulation methods, System Dynamics, Agent Based Modelling and Discrete Event Simulation all achieve this to varying degrees. There is some evidence that all three methods can, within limits, represent the key aspects of the system being modelled. The three simulation approaches are then assessed for their suitability in modelling these various aspects. Illustration of behavioural modelling will be provided from cases in supply chain management, evacuation modelling and rail disruption.

Enhanced process verification through re-engineering the manufacturing procedure

In today’s modern manufacturing industry there is an increasing need to improve internal processes to meet diverse client needs. Process re-engineering is an important activity that is well understood by industry but its rate of application within small to medium size enterprises (SME) is less developed. Business pressures shift the focus of SMEs toward winning new projects and contracts rather than developing long-term, sustainable manufacturing processes. Variations in manufacturing processes are inevitable, but the amount of non-conformity often exceeds the acceptable levels. This paper is focused on the re-engineering of the manufacturing and verification procedure for discrete parts production with the aim of enhancing process control and product verification. The ideologies of the ‘Push’ and ‘Pull’ approaches to manufacturing are useful in the context of process re-engineering for data improvement. Currently information is pulled from the market and prominent customers, and manufacturing companies always try to make the right product, by following customer procedures that attempt to verify against specifications. This approach can result in significant quality control challenges. The aim of this paper is to highlight the importance of process re-engineering in product verification in SMEs. Leadership, culture, ownership and process management are among the main attributes required for the successful deployment of process re-engineering. This paper presents the findings from a case study showcasing the application of a modified re-engingeering method for the manufacturing and verification process. The findings from the case study indicate there are several advantages to implementing the re-engineering method outlined in this paper.

Implementation of a machine tool performance measurement and diagnostic system and its impact on parts verification

Five axis machine tools are increasing and becoming more popular as customers demand more complex machined parts. In high value manufacturing, the importance of machine tools in producing high accuracy products is essential. High accuracy manufacturing requires producing parts in a repeatable manner and precision in compliance to the defined design specifications. The performance of the machine tools is often affected by geometrical errors due to a variety of causes including incorrect tool offsets, errors in the centres of rotation and thermal growth. As a consequence, it can be difficult to produce highly accurate parts consistently. It is, therefore, essential to ensure that machine tools are verified in terms of their geometric and positioning accuracy. When machine tools are verified in terms of their accuracy, the resulting numerical values of positional accuracy and process capability can be used to define design for verification rules and algorithms so that machined parts can be easily produced without scrap and little or no after process measurement. In this paper the benefits of machine tool verification are listed and a case study is used to demonstrate the implementation of robust machine tool performance measurement and diagnostics using a ballbar system.

Serum-free process development:improving the yield and consistency of human mesenchymal stromal cell production

Background aims: The cost-effective production of human mesenchymal stromal cells (hMSCs) for off-the-shelf and patient specific therapies will require an increasing focus on improving product yield and driving manufacturing consistency. Methods: Bone marrow-derived hMSCs (BM-hMSCs) from two donors were expanded for 36 days in monolayer with medium supplemented with either fetal bovine serum (FBS) or PRIME-XV serum-free medium (SFM). Cells were assessed throughout culture for proliferation, mean cell diameter, colony-forming potential, osteogenic potential, gene expression and metabolites. Results: Expansion of BM-hMSCs in PRIME-XV SFM resulted in a significantly higher growth rate (P < 0.001) and increased consistency between donors compared with FBS-based culture. FBS-based culture showed an inter-batch production range of 0.9 and 5 days per dose compared with 0.5 and 0.6 days in SFM for each BM-hMSC donor line. The consistency between donors was also improved by the use of PRIME-XV SFM, with a production range of 0.9 days compared with 19.4 days in FBS-based culture. Mean cell diameter has also been demonstrated as a process metric for BM-hMSC growth rate and senescence through a correlation (R² = 0.8705) across all conditions. PRIME-XV SFM has also shown increased consistency in BM-hMSC characteristics such as per cell metabolite utilization, in vitro colony-forming potential and osteogenic potential despite the higher number of population doublings. Conclusions: We have increased the yield and consistency of BM-hMSC expansion between donors, demonstrating a level of control over the product, which has the potential to increase the cost-effectiveness and reduce the risk in these manufacturing processes.

Web designers, social e-value creation and e-business planning:understanding resistance from conflicting demands

This chapter investigates the conflicting demands faced by web designers in the development of social e-atmospherics that aim to encourage e-value creation, thus strengthening and prolonging market planning strategies. While recent studies have shown that significant shifts are occurring concerning the importance of users’ generated content by way of social e-communication tools (e.g. blogs), these trends are also creating expectations that social and cultural cues ought to become a greater part of e-atmospherics and e-business strategies. Yet, there is growing evidence that organizations are resisting such efforts, fearing that they will lose control of their e-marketing strategy. This chapter contributes to the theory and literature on online cross-cultural understanding and the impact website designers (meso-level) can have on improving the sustainability of e-business planning, departing from recent studies that focus mainly on firms’ e-business plans (macro-level) or final consumers (micro-level). A second contribution is made with respect to online behavior regarding the advancement of technologies that facilitate the development and shaping of new social e-atmospherics that affect users’ behavior and long term e-business strategies through the avoidance of traditional, formal decision making processes and marketing strategy mechanisms implemented by firms. These issues have been highlighted in the literature on the co-production and co-creation of value, which few organizations have thus far integrated in their strategic and pragmatic e-business plans. Drawing upon fifteen online interviews with web designers in the USA, as key non-institutional actors at the meso-level who are developing what future websites will be like, this chapter analyzes ways in which identifying points of resistance and conflicting demands can lead to engagement with the debate over the online co-creation of value and more sustainable future e-business planning. A number of points of resistance to the inclusion of more e-social atmospherics are identified, and the implications for web designers’ roles and web design planning are discussed along with the limitations of the study and potential future research for e-business studies.

Systematic microcarrier screening and agitated culture conditions improves human mesenchymal stem cell yield in bioreactors

Production of human mesenchymal stem cells for allogeneic cell therapies requires scalable, cost-effective manufacturing processes. Microcarriers enable the culture of anchorage-dependent cells in stirred-tank bioreactors. However, no robust, transferable methodology for microcarrier selection exists, with studies providing little or no reason explaining why a microcarrier was employed. We systematically evaluated 13 microcarriers for human bone marrow-derived MSC (hBM-MSCs) expansion from three donors to establish a reproducible and transferable methodology for microcarrier selection. Monolayer studies demonstrated input cell line variability with respect to growth kinetics and metabolite flux. HBM-MSC1 underwent more cumulative population doublings over three passages in comparison to hBM-MSC2 and hBM-MSC3. In 100 mL spinner flasks, agitated conditions were significantly better than static conditions, irrespective of donor, and relative microcarrier performance was identical where the same microcarriers outperformed others with respect to growth kinetics and metabolite flux. Relative growth kinetics between donor cells on the microcarriers were the same as the monolayer study. Plastic microcarriers were selected as the optimal microcarrier for hBM-MSC expansion. HBM-MSCs were successfully harvested and characterised, demonstrating hBM-MSC immunophenotype and differentiation capacity. This approach provides a systematic method for microcarrier selection, and the findings identify potentially significant bioprocessing implications for microcarrier-based allogeneic cell therapy manufacture. Large-scale production of human bone-marrow derived mesenchymal stem cells (hBM-MSCs) requires expansion on microcarriers in agitated systems. This study demonstrates the importance of microcarrier selection and presents a systematic methodology for selection of an optimal microcarrier. The study also highlights the impact of an agitated culture environment in comparison to a static system, resulting in a significantly higher hBM-MSC yield under agitated conditions.

Development of a technological innovation capability assessment model:a case study of manufacturing SMEs in Sialkot, Pakistan

Small and Medium Enterprises (SMEs) play an important part in the economy of any country. Initially, a flat management hierarchy, quick response to market changes and cost competitiveness were seen as the competitive characteristics of an SME. Recently, in developed economies, technological capabilities (TCs) management- managing existing and developing or assimilating new technological capabilities for continuous process and product innovations, has become important for both large organisations and SMEs to achieve sustained competitiveness. Therefore, various technological innovation capability (TIC) models have been developed at firm level to assess firms‘ innovation capability level. These models output help policy makers and firm managers to devise policies for deepening a firm‘s technical knowledge generation, acquisition and exploitation capabilities for sustained technological competitive edge. However, in developing countries TCs management is more of TCs upgrading: acquisitions of TCs from abroad, and then assimilating, innovating and exploiting them. Most of the TIC models for developing countries delineate the level of TIC required as firms move from the acquisition to innovative level. However, these models do not provide tools for assessing the existing level of TIC of a firm and various factors affecting TIC, to help practical interventions for TCs upgrading of firms for improved or new processes and products. Recently, the Government of Pakistan (GOP) has realised the importance of TCs upgrading in SMEs-especially export-oriented, for their sustained competitiveness. The GOP has launched various initiatives with local and foreign assistance to identify ways and means of upgrading local SMEs capabilities. This research targets this gap and developed a TICs assessment model for identifying the existing level of TIC of manufacturing SMEs existing in clusters in Sialkot, Pakistan. SME executives in three different export-oriented clusters at Sialkot were interviewed to analyse technological capabilities development initiatives (CDIs) taken by them to develop and upgrade their firms‘ TCs. Data analysed at CDI, firm, cluster and cross-cluster level first helped classify interviewed firms as leader, follower and reactor, with leader firms claiming to introduce mostly new CDIs to their cluster. Second, the data analysis displayed that mostly interviewed leader firms exhibited ‗learning by interacting‘ and ‗learning by training‘ capabilities for expertise acquisition from customers and international consultants. However, these leader firms did not show much evidence of learning by using, reverse engineering and R&D capabilities, which according to the extant literature are necessary for upgrading existing TIC level and thus TCs of firm for better value-added processes and products. The research results are supported by extant literature on Sialkot clusters. Thus, in sum, a TIC assessment model was developed in this research which qualitatively identified interviewed firms‘ TIC levels, the factors affecting them, and is validated by existing literature on interviewed Sialkot clusters. Further, the research gives policy level recommendations for TIC and thus TCs upgrading at firm and cluster level for targeting better value-added markets.

Innovativeness of Indian firms - catalysts and deterrents

Innovation is the driving force that is crucial for firms to sustain their competitive advantage and for economies and industries in general to surge forward. In comparison to developing economies, developed economies have always maintained greater focus on national innovation systems while the firms from these economies have been investing considerable effort on promoting organisational innovation. As firms became increasingly global, consumers across the world, especially from the emerging economies, are getting a taste of more sophisticated products and services. There was also an infusion of knowledge pertaining to cutting-edge technologies, innovation, processes and management systems into this part of the world. However, studies on organisational innovation have largely been confined to firms from developed economies in order to understand the effects of its determinants (Anderson et al., 2004; Choi and Williams, 2014; Li et al., 2013). Given the differences in the socio-cultural milieu between the developed and emerging economies, more nuanced understanding of the factors affecting and the processes associated with innovation in emerging markets is required.