Manufacturing challenges in the new millenium:the Asia-Pacific response

Editorial

The translation of cell-based therapies:clinical landscape and manufacturing challenges

Cell-based therapies have the potential to make a large contribution toward currently unmet patient need and thus effective manufacture of these products is essential. Many challenges must be overcome before this can become a reality and a better definition of the manufacturing requirements for cell-based products must be obtained. The aim of this study is to inform industry and academia of current cell-based therapy clinical development and to identify gaps in their manufacturing requirements. A total of 1342 active cell-based therapy clinical trials have been identified and characterized based on cell type, target indication and trial phase. Multiple technologies have been assessed for the manufacture of these cell types in order to facilitate product translation and future process development.

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.

DFMA-ohjeistuksen laatiminen tuulivoimateollisuuden mekaniikkasuunnittelijoille

Osien hyvä valmistettavuus on aina asettanut haasteita suunnittelulle. Yritysten verkostoituminen lisää haasteellisuutta, kun tuotteiden suunnittelu tehdään erillään kokoonpanosta ja osavalmistus tapahtuu alihankintana. Tällöin on ensiarvoisen tärkeää, että suunnittelulla on tarvittavat perustiedot eri valmistusmenetelmistä, jotta suunniteltujen osien valmistus ja kokoonpano luonnistuu ongelmitta. Työn alun kirjallisuusosiossa käsitellään suunnittelun teoriaa, joka toimii perustana hyvälle osasuunnittelulle. Teorian lisäksi työssä käsitellään eri työmenetelmiä koskevat rajoitukset ja mahdollisuudet. Oikein suunniteltu osa on työstömenetelmien kannalta hyvin valmistettavissa, työ voidaan tehdä taloudellisilla työmenetelmillä ja kokoonpanossa osat sopivat yhteen ilman sovitustyötä. Käytännön osuudessa on käsitelty The Switch Drive Systems Oy:n tuotteiden valmistettavuuden kehityskohteita, joilla tuotteiden valmistettavuutta voidaan parantaa. Kehityskohteiden perusteella on laadittu valmistusmenetelmäkohtainen suunnittelun ohjeistus, jonka avulla kehitetään The Switchin suunnittelua vastaamaan paremmin laitetoimittajien tarpeisiin. Näiden ohjeistuksien avulla voidaan kehittää suunnittelutyötä siten, että osien valmistettavuus sekä laatu paranevat ja kokoonpano nopeutuu.

Development of a microbicide-releasing diaphragm as an HIV prevention strategy

Contraceptive diaphragms offer a discreet method of pregnancy protection that women can use when needed with no side effects. Incorporating antiretroviral HIV microbicides into such devices may also provide protection against HIV infection. The paper gives a brief outline of the work being conducted by PATH, CONRAD and QUB on the development of a microbicide-releasing SILCS diaphragm. The design, engineering and manufacturing challenges that have been encountered will be discussed, as well as the potential impact such a device could have in the developing world.

Advances in single-shot, dry drilling of composite/metal stacks

Carbon fibre reinforced polymers (CFRP) are increasingly being used in the aerospace, automotive and defence industry due to their high specific stiffness and good corrosion resistance. In a modern aircraft, 50-60% of its structure is made up of CFRP material while the remainder is mostly a combination of metallic alloys (typically aluminium or titanium alloys). Mechanical fastening (bolting or riveting) of CFRP and metallic components has thus created a pressing requirement of drilling several thousand holes per aircraft. Drilling of stacks in a single-shot not only saves time, but also ensures proper alignment when fasteners are inserted, achieving tighter geometric tolerances. However, this requirement poses formidable manufacturing challenges due to the fundamental differences in the material properties of CFRP and metals e.g. a drill bit entering into the stack encounters brittle and abrasive CFRP material as well as the plastic behaviour of the metallic alloy, making the drilling process highly non-linear.

Over the past few years substantial efforts have been made in this direction and majority of the research has tried to establish links between how the process parameters (feed, depth of cut, cutting speed), tooling (geometry, material and coating) and the wear of the cutting tool affect the hole quality. Similarly, multitudes of investigations have been conducted to determine the effects of non-traditional drilling methods (orbital, helical and vibration assisted drilling), cutting zone temperatures and efficiency of chip extraction on the hole quality and rate of tool wear during single shot drilling of CFRP/alloy stacks.

In a timely effort, this paper aims at reviewing the manufacturing challenges and barriers faced when drilling CFRP/alloy stacks and to summarise various factors influencing the drilling process while detailing the advances made in this fertile research area of single-shot drilling of stack materials. A survey of the key challenges associated with avoiding workpiece damage and the effect these challenges have on tool design and process optimisation is presented. An in depth critique of suitable hole making methods and their aptness for commercialisation follows. The paper concludes by summarising the future work required to achieve repeatable, high quality single shot drilled holes in CFRP/alloy stacks.

Facing the climate change challenges in the mining and mineral industry as providers of a sustainable manufacturing process

A sustainable manufacturing process must rely on an also sustainable raw materials and energy supply. This paper is intended to show the results of the studies developed on sustainable business models for the minerals industry as a fundamental previous part of a sustainable manufacturing process. As it has happened in other economic activities, the mining and minerals industry has come under tremendous pressure to improve its social, developmental, and environmental performance. Mining, refining, and the use and disposal of minerals have in some instances led to significant local environmental and social damage. Nowadays, like in other parts of the corporate world, companies are more routinely expected to perform to ever higher standards of behavior, going well beyond achieving the best rate of return for shareholders. They are also increasingly being asked to be more transparent and subject to third-party audit or review, especially in environmental aspects. In terms of environment, there are three inter-related areas where innovation and new business models can make the biggest difference: carbon, water and biodiversity. The focus in these three areas is for two reasons. First, the industrial and energetic minerals industry has significant footprints in each of these areas. Second, these three areas are where the potential environmental impacts go beyond local stakeholders and communities, and can even have global impacts, like in the case of carbon. So prioritizing efforts in these areas will ultimately be a strategic differentiator as the industry businesses continues to grow. Over the next forty years, world?s population is predicted to rise from 6.300 million to 9.500 million people. This will mean a huge demand of natural resources. Indeed, consumption rates are such that current demand for raw materials will probably soon exceed the planet?s capacity. As awareness of the actual situation grows, the public is demanding goods and services that are even more environmentally sustainable. This means that massive efforts are required to reduce the amount of materials we use, including freshwater, minerals and oil, biodiversity, and marine resources. It?s clear that business as usual is no longer possible. Today, companies face not only the economic fallout of the financial crisis; they face the substantial challenge of transitioning to a low-carbon economy that is constrained by dwindling natural resources easily accessible. Innovative business models offer pioneering companies an early start toward the future. They can signal to consumers how to make sustainable choices and provide reward for both the consumer and the shareholder. Climate change and carbon remain major risk discontinuities that we need to better understand and deal with. In the absence of a global carbon solution, the principal objective of any individual country should be to reduce its global carbon emissions by encouraging conservation. The mineral industry internal response is to continue to focus on reducing the energy intensity of our existing operations through energy efficiency and the progressive introduction of new technology. Planning of the new projects must ensure that their energy footprint is minimal from the start. These actions will increase the long term resilience of the business to uncertain energy and carbon markets. This focus, combined with a strong demand for skills in this strategic area for the future requires an appropriate change in initial and continuing training of engineers and technicians and their awareness of the issue of eco-design. It will also need the development of measurement tools for consistent comparisons between companies and the assessments integration of the carbon footprint of mining equipments and services in a comprehensive impact study on the sustainable development of the Economy.

The servitization of manufacturing:a review of literature and reflection on future challenges

Purpose – The purpose of this paper is to report the state-of-the-art of servitization by presenting a clinical review of literature currently available on the topic. The paper aims to define the servitization concept, report on its origin, features and drivers and give examples of its adoption along with future research challenges. Design/methodology/approach – In determining the scope of this study, the focus is on articles that are central and relevant to servitization within a wider manufacturing context. The methodology consists of identifying relevant publication databases, searching these using a wide range of key words and phrases associated with servitization, and then fully reviewing each article in turn. The key findings and their implications for research are all described. Findings – Servitization is the innovation of an organisation's capabilities and processes to shift from selling products to selling integrated products and services that deliver value in use. There are a diverse range of servitization examples in the literature. These tend to emphasize the potential to maintain revenue streams and improve profitability. Practical implications – Servitization does not represent a panacea for manufactures. However, it is a concept of significant potential value, providing routes for companies to move up the value chain and exploit higher value business activities. There is little work to date that can be used to help practitioners. Originality/value – This paper provides a useful review of servitization and a platform on which to base more in-depth research into the broader topic of service-led competitive strategy by drawing on the work from other related research communities.

Future challenges for manufacturing

Purpose - This Editorial Viewpoint explores what changes are taking place in manufacturing technology management with the aim of identifying future challenges that should be represented in the scope of JMTM. Design/methodology/ approach - The viewpoints use an analysis of relevant articles in JMTM, published since 2007, which have focused on future challenges for manufacturing. It also draws on two recent reports. Findings - While the analysis confirms the inclusion of some subjects already in the journal scope, there are elsewhere gaps that merit it being expanded. Research limitations/implications - Evidence for the findings is only from a limited number of articles identified in this journal together supplemented by other secondary sources. Practical implications - There are implications for practice concerning the future of manufacturing from the analysis and the sources used, especially the reports. Originality/value - Although it has limitations, the article is based on original bibliographic research. Copyright © 2014 Emerald Group Publishing Limited. All rights reserved.

Manufacturing process challenges when machining superalloys

The implementation of advanced manufacturing systems with high process capability is an essential requirement for the high value manufacturing industries. To ensure high process capability, industry needs to deal with the requirement for tight tolerances and the unavoidable variations in materials, and manufacturing and inspection processes. In the case of machining superalloys, such variations result in the need to change the machine parameters for producing different batches of materials from different suppliers. This is required in order to get the process under control and reduce waste and defects, leading to better competitiveness. This papers discuss the variability in materials and the corresponding process requirements when machining superalloys, and highlights the impact of metrology in achieving manufacturing process improvement.

Industrial challenges in grinding

This keynote paper aims at analyzing relevant industrial demands for grinding research. The chosen focus is to understand what are the main research challenges in the extensive industrial use of the process. Since the automotive applications are the most important driving forces for grinding development, the paper starts with an analysis on the main trends in more efficient engines and the changes in their components that will affect the grinding performance. A view from 23 machine tool builders is also presented based on a survey made in interviews and during the EMO and IMTS machine tool shows. Case studies received by the STC G members were used to show how research centers and industries are collaborating. A view from the authors and the final conclusions show hot topics for future grinding research. (C) 2009 CIRP.