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Objective The COVID-19 pandemic is a biosecurity threat, and many resource-rich countries are stockpiling and/or making plans to secure supplies of vaccine, therapeutics, and diagnostics for their citizens. We review the products that are being investigated for the prevention, diagnosis, and treatment of COVID-19; discuss the challenges that countries in sub-Saharan Africa may face with access to COVID-19 vaccine, therapeutics, and diagnostics due to the limited capacity to manufacture them in Africa; and make recommendations on actions to mitigate these challenges and ensure health security in sub-Saharan Africa during this unprecedented pandemic and future public-health crises. Main body Sub-Saharan Africa will not be self-reliant for COVID-19 vaccines when they are developed. It can, however, take advantage of existing initiatives aimed at supporting COVID-19 vaccine access to resource-limited settings such as partnership with AstraZeneca, the Coalition for Epidemic Preparedness and Innovation, the Global Alliance for Vaccine and Immunisation, the Serum Institute of India, and the World Health Organization’s COVID-19 Technology Access Pool. Accessing effective COVID-19 therapeutics will also be a major challenge for countries in sub-Saharan Africa, as production of therapeutics is frequently geared towards profitable Western markets and is ill-adapted to sub-Saharan Africa realities. The region can benefit from pooled procurement of COVID-19 therapy by the Africa Centres for Disease Control and Prevention in partnership with the African Union. If the use of convalescent plasma for the treatment of patients who are severely ill is found to be effective, access to the product will be minimally challenging since the region has a pool of recovered patients and human resources that can man supportive laboratories. The region also needs to drive the local development of rapid-test kits and other diagnostics for COVID-19. Conclusion Access to vaccines, therapeutics, and diagnostics for COVID-19 will be a challenge for sub-Saharan Africans. This challenge should be confronted by collaborating with vaccine developers; pooled procurement of COVID-19 therapeutics; and local development of testing and diagnostic materials. The COVID-19 pandemic should be a wake-up call for sub-Saharan Africa to build vaccines, therapeutics, and diagnostics manufacturing capacity as one of the resources needed to address public-health crises.

3D printing consisted of in-situ UV-curing module can build complex 3D structures, in which direct ink writing can handle versatile materials. However, UV-based direct ink writing (DIW) is facing a trade-off between required curing intensity and effectiveness range, and it cannot implement multiscale parallelization at ease. We overcome these difficulties by ink design and introducing near-infrared (NIR) laser assisted module, and this increases the scalability of direct ink writing to solidify the deposited filament with diameter up to 4 mm, which is much beyond any of existing UV-assisted DIW. The NIR effectiveness range can expand to tens of centimeters and deliver the embedded writing capability. We also demonstrate its parallel manufacturing capability for simultaneous curing of multi-color filaments and freestanding objects. The strategy owns further advantages to be integrated with other types of ink-based 3D printing technologies for extensive applications., Currently UV-based direct ink writing (DIW) is facing a trade-off between required curing intensity and effectiveness range. Here the authors overcome this problem by introducing near-infrared photopolymerization into DIW

This paper presents the idea of supporting product inspection planning process during the early stages of product life cycle for the experts working on product development. Aim of this research is to assist a collaborative product development process by using Smart Virtual Product Development (SVPD) system, which is based on Set of Experience Knowledge Structure (SOEKS) and Decisional DNA (DDNA). The proposed system is developed to support three key aspects of industrial product development i.e. design, manufacturing, and product inspection. Therefore, it comprises of three main modules; design knowledge management (DKM), manufacturing capability and process planning (MCAPP), and product inspection planning (PIP). It collects, stores, and uses experiential knowledge from formal decisional events in the form of set of experience (SOE). This research enlightens the working mechanism of the PIP module, and shows how experiential knowledge related to product inspection can be used during the early stages of product development process. This experiential knowledge is extracted and stored from similar products having some common features and functions. First, the basic description and principles of the approach are introduced, then the prototype version of the system is developed and tested for product inspection planning (PIP) module for the case study, which verifies the feasibility of the proposed approach. The presented system successfully supports smart manufacturing and can play a vital role in Industry 4.0.

A new type of pure carbon fiber (C f ) preform with complex shape was prepared by gel-casting. C f /SiC composite with high performance was rapidly prepared by reactive melt infiltration (RMI). The microstructure which determined the mechanical properties of the C f /SiC composites could be controlled by in-situ fiber coating preparation process. The fracture toughness of the C f /SiC composite with SiC and PyC coating, 8.3 ± 1.5 MPa m 1/2 , was far superior to pure SiC ceramic prepared by RMI. This method showed excellent manufacturing capability and remarkable potential in fabrication of C f /SiC composites with complex shape and high mechanical performance.

This paper aims to investigate the manufacturing strategies for the manufacturing systems in the context of 3D printing, referring to ecosystem-based manufacturing systems, rather than firm-based and network-based ones. A case study approach was adopted for this research, as the data was mainly collected via semi-structured interviews with staff members of companies in China. Besides the elements of strategic choices and manufacturing capabilities identified in the extant literature, this research verified three additional strategic choice elements (functional role, platform and solution) and identified two factors (platform openness and solution diversity) to classify an ecosystem-based manufacturing system. Meanwhile, four manufacturing capabilities of the ecosystem-based manufacturing system have been identified: collaborative manufacturing flexibility, rapid thriftiness ability, self-customisation and co-evolved design capability. This research results contribute to the area of manufacturing strategy via expanding its view from the firm and network levels to the ecosystem level. Meanwhile, the research results present operations managers with an understanding of the strategic choices and manufacturing capabilities of an ecosystem-based manufacturing system in the context of 3D printing.

Purpose: Manufacturing MSMEs are in need to identify new ideas and work on ideas to implement them into their process to create new or improved products. Innovation management is a prerequisite and has a direct effect on a firm’s performance. Innovation allows firms to secure a market position and create value by making new customers. This study attempts to find the relationship between innovative capabilities and the firm’s performance in manufacturing MSMEs and how the commercial capabilities of the firm moderate the relationship. Theoretical Framework: Several studies have been reviewed to identify the relationship between innovation, firm performance, and commercial capabilities. A necessitated gap in the literature was identified and the factors were established. Design/Methodology/approach: This study was done among the manufacturing MSMEs in India. A structured questionnaire was circulated to the top performing MSMEs in every state of India and the responses were collected through email. A total of 384 responses were collected at the end of the data collection period. The scale of the measure was adopted and it has measured reliability and validity scores to get to be used in this study. Findings: The results of the study showed that the innovative capability of manufacturing MSMEs has a significant positive relationship with the firm’s performance. The moderation analysis showed that the manufacturing capability and marketing capability significantly moderate the relationship between innovative capability and a firm’s performance. Research, Practical & Social Implications: This study provides the managers of the manufacturing MSMEs to rely on investment in innovation however they are moderately influenced by networking, R&D, and commercial capabilities of the business. Originality/Value: Contributes to the existing body of knowledge theoretically and empirically by including diverse demographic respondents the results obtained were unique and universally applicable.

Despite the vital role of vaccines in fighting viral pathogens, effective vaccines are still unavailable for many infectious diseases. The importance of vaccines cannot be overstated during the outbreak of a pandemic, such as the coronavirus disease 2019 (COVID-19) pandemic. The understanding of genomics, structural biology, and innate/adaptive immunity have expanded the toolkits available for current vaccine development. However, sudden outbreaks and the requirement of population-level immunization still pose great challenges in today's vaccine designs. Well-established vaccine development protocols from previous experiences are in place to guide the pipelines of vaccine development for emerging viral diseases. Nevertheless, vaccine development may follow different paradigms during a pandemic. For example, multiple vaccine candidates must be pushed into clinical trials simultaneously, and manufacturing capability must be scaled up in early stages. Factors from essential features of safety, efficacy, manufacturing, and distributions to administration approaches are taken into consideration based on advances in materials science and engineering technologies. In this review, we present recent advances in vaccine development by focusing on vaccine discovery, formulation, and delivery devices enabled by alternative administration approaches. We hope to shed light on developing better solutions for faster and better vaccine development strategies through the use of biomaterials, biomolecular engineering, nanotechnology, and microfabrication techniques.

Good manufacturing practice (GMP) is advocated and implemented as a standardized procedure for manufacturing dietary supplements. However, in Japan as a case, only half of the manufacturers in this field so far adopt it. To address this issue, the present study aims to explore the effect of key characteristics of a company on the adoption of and compliance with GMP for dietary supplements. The focus is on the effect of expertise in the pharmaceutical industry. The relationships between company characteristics and the adoption of GMP were analyzed for 90 manufacturers in the dietary supplement industry in Japan. A binomial logistic regression analysis showed that each of the following three factors had a positive and significant effect on the company&rsquo, s adoption of GMP: company size in terms of revenue (odds ratio = 1.04, p = 0.019), possession of a manufacturing license for pharmaceutical products (13.7, p = 0.003), and number of own product categories manufactured (3.93, p = 0.00009). These findings strongly suggest that the company&rsquo, s manufacturing capability of pharmaceutical products works as a key driver for the better adoption of a quality standard in the dietary supplement industry in Japan. Few considerations were made for conditions of the adoption and implementation of GMP. The present study empirically contributes by providing key clues for issues in the dietary supplement industry and by forming a theoretical base for policymakers and the regulatory authorities.

In the past few years, additive manufacturing with metal powders industry has gained rapid traction in the metal manufacturing sector, prominently in those regions where conventional manufacturing encounters limitations related to manufacturing capability and design methodology.

Cell and gene therapy products are rapidly being integrated into mainstream medicine. Developing global capability will facilitate broad access to these novel therapeutics. An initial step toward achieving this goal is to understand cell and gene therapy manufacturing capability in each region. We conducted an academic survey in 2018 to assess cell and gene therapy manufacturing capacity in Australia and New Zealand. We examined the following: the number and types of cell therapy manufacturing facilities; the number of projects, parallel processes and clinical trials; the types of products; and the manufacturing and quality staffing levels. It was found that Australia and New Zealand provide diverse facilities for cell therapy manufacturing, infrastructure and capability. Further investment and development will enable both countries to make important decisions to meet the growing need for cell and gene therapy and regenerative medicine in the region.

Calibration tests are of great importance to ensure rate-sensing accuracy of GyroWheel, an innovative attitude determination and control device. In the process of calibration tests, turntable errors are inevitable, which hinder the calibration accuracy and rate-sensing capability. Hence, error analysis for GyroWheel calibration tests is conducted, and the relationship between the calibration accuracy and the orientation error is established based on analytical derivation and numerical simulations. Subsequently, an error model of the turntable system is derived using rigid body kinematics, by which the relationship between the orientation error and turntable errors is described. According to sensitivity analysis and manufacturing capability, an error allocation method is proposed to determine the accuracy requirement of the test turntable, and the effectiveness of the proposed method is verified by repeated simulation tests. Based on the presented analysis and proposed method in this paper, the effects of various turntable errors on the calibration accuracy can be obtained quantitatively, and a theoretical basis for the determination of the turntable accuracy is provided, which are of great significance to guide the calibration tests and improve the calibration accuracy of GyroWheel.

The purpose of this paper is to investigate the development of manufacturing capabilities in Central and Eastern Europe. In particular, top management's competitive priorities, plants' manufacturing strategies, and plants' manufacturing performances are compared between old and new European Union member states. Internationally collected data are compared using various analyses of covariance. The findings are interpreted against the background of the sand cone model, which is extended by integrating sustainability twice—that is, in its proactive and reactive forms. The results indicate that old and new member states dwell on different steps of cumulative manufacturing capability development. It is hypothesized that this can be attributed to differing labor costs; the requirements imposed by supply chains; and the pressure from stakeholders, such as civil society organizations. Our study responds to various calls to refine the sand cone model through the use of contingency theory by considering the operating conditions of plants in the two country groups as environmental contingency factors.

Facing the challenge of rapid response to customer personalized demand and developing high quality competitive ordnance equipment, the paper proposes a capability-driven dynamic federal collaborative design methodology to support inter-enterprise development. The core is dynamic constructing collaborative development capability federation (CDCF) by combinatorial optimizing and intelligent disposing various inter-enterprise designing and manufacturing capability. The paper presents the business model and capability models of CDCF and focuses on the capability constraints-based constructing method and requirement-capability matching algorithm of CDCF. Applying service-oriented architecture (SOA)-based integrating method, the inter-enterprise federal collaborative development platform was constructed. Finally, a heavy military vehicle inter-enterprise collaborative design engineering application case validates the effectiveness and feasibility of the method.

The subject of this column is a quite remarkable German aircraft from World War II (WW2): the Horten Ho-229. This was a single-seat fighter/bomber aircraft with a steel and laminated plywood airframe, powered by two turbojet engines, and designed and built by the Horten brothers, Walter and Reimer. Its maximum speed was close to 1000 km/h. It looks for all the world like a modern-day stealth aircraft - but from 75 years ago. A prototype aircraft flew in test flights in February 1945 - just three months before the end of WW2 in Europe. The results were encouraging, but there was no time and no manufacturing capability to develop it to operational status. The prototype was recovered as the Allies overran Germany, and now-declassified documents in the British National Archives show that the airframe was carefully inspected and the performance assessed. It is not clear how much of this information may have been used in the design of the Northrop XB-35 (1946) and YB-49 (1947) "flying wing" aircraft. The prototype aircraft lay in storage for many years, but has now been taken to the Smithsonian Udvar-Hazy museum, close to Dulles airport, VA, USA, where it is being restored.

We are in an exciting period in history, as advances in our understanding of biology tell us how networks of DNA, RNA, proteins, and other molecules influence human health and disease. In order to detect all these molecules, measure their concentrations, and convert that into data that can be accessed digitally, we need the appropriate interface: a sensor. This talk will discuss the ways we are developing new optical sensor systems that can be used as diagnostic systems in the clinical lab, at the point of care, and (eventually) at home. Achieving these goals requires advances in chemistry, materials science, optics, and the fabrication technologies to make it all work “at scale”, in a format that can go beyond the laboratory and into the commercial sphere. Integrated photonics is a particularly attractive option for building broadly useful sensor platforms. Here, the light source, sensing mechanism, and detection system are all in the same plane. As such, these sensors are small and simple enough that they could be incorporated into a cell phone. For the past five years, we have worked in partnership with the American Institute for Manufacturing Integrated Photonics (AIM Photonics) to establish designs and manufacturing strategies for photonic chemical and biological sensors. AIM is a public-private partnership established to develop US manufacturing capability in photonics. This talk will detail progress in demonstrating AIM Photonics’ fabrication capabilities in chemical and biological sensing, with a particular focus on rapid assays for SARS-CoV-2, the virus causing COVID-19 disease.

This paper critically reviewed empirical studies of manufacturing capabilities to identify possible inconsistencies in the composition and use of multiple item capability measures. In addition, this paper examined the issue of item commonality which is the extent to which questionnaire items corresponding to a capability were used by the studies to measure the capability. This paper also explored the potential effects of inconsistencies in measure composition and use on survey validity and on item commonality. Twenty-seven papers met the review criteria delineated in the paper. Review results revealed a striking lack of consensus in measure sourcing, Likert scale framing and the use of validity checks in measure composition. Furthermore, only six survey items used in the studies can be thought of as high commonality items. Given these results

The pressurized water reactor CAP1400 is one of the sixteen National Science and Technology Major Projects. Developed from China's nuclear R&D system and manufacturing capability, as well as AP1000 technology introduction and assimilation, CAP1400 is an advanced large passive nuclear power plant with independent intellectual property rights. By discussing the top design principle, main performance objectives, general parameters, safety design, and important improvements in safety, economy, and other advanced features, this paper reveals the technology innovation and competitiveness of CAP1400 as an internationally promising Gen-III PWR model. Moreover, the R&D of CAP1400 has greatly promoted China's domestic nuclear power industry from the Gen-II to the Gen-III level.

This research investigates the determinants of the performance of small and medium sized manufacturers on business-to-business electronic marketplaces (B2B EMs). Based on the resource-based view, the framework proposed suggests that a manufacturing firm's performance on a B2B EM is determined by EM enabling capabilities, namely the online marketing capability, flexible manufacturing capability and content management capability. Further, the framework posits that these EM enabling capabilities are in turn determined by the firm's IT capability. Data from 358 online manufacturers participating in a B2B EM is collected and analyzed. The results confirm our hypotheses that the online marketing capability, flexible manufacturing capability and content management capability fully mediate the impact of the IT capability on the firm's online performance. Furthermore, the online marketing capability is found to be a stronger factor in influencing the manufacturer's online performance than the others. Performance of manufacturers operating on B2B electronic marketplaces is studied.The model explaining the performance includes IT capability and EM enabling capabilities of the manufacturers.The research model was tested using data from 358 online manufacturers.IT capability positively affect the performance of manufacturers through the mediation of EM enabling capabilities.

The presence of aggregates in biopharmaceutical products has long been considered a concern to product safety and product quality. Specifications for acceptable levels of aggregates for a novel therapeutic protein are typically set based on manufacturing capability and clinical qualification. While these parameters are still relevant for biosimilars, additional strategy must also be applied to ensure that the aggregate profile is acceptable in comparison to the originator product, both in terms of number and types of aggregates present. This article discusses regulatory strategy that may be employed in the development of analytical methods and specifications for a biosimilar product.

A privately owned semiconductor test equipment company was sold by its U.S. domestic owners (seller) to a purchaser having an overseas manufacturing location (buyer). The sale was to take place in several stages. The buyer asserted that when the agreement was made he was unaware that the seller’s flagship product was being rejected by customers for not meeting specifications. When this came to light, the buyer refused to continue with the second and subsequent stages of purchase. The seller then sued the buyer for not complyingwith the agreement, and the buyer counter-sued for fraudulent deception. The author was retained by the buyer’s attorney to review specification documents regarding the product, due diligence reports, and e-mail chains regarding product quality, field returns, and repairs.

Automotive industry is believed to be the pioneer in pushing the growth of manufacturing industry in Indonesia. By implementing manufacturing strategy, the industry will get its performance improved. Automotive component manufacturer is an important part of automotive industry. This research discusses the relationship between influential variables with performance in Indonesia automotive component manufacturer namely manufacturing capability and manufacturing strategy. A model is developed and data are collected from automotive component manufacturers around Jakarta area. Data is processed using Structural Equation Modeling (SEM). The result shows that manufacturing capability significantly influences manufacturing strategy while manufacturing strategy also significantly influences performance of Indonesia automotive component manufacturer.

Changeovers stand as a critical operation in the manufacturing companies, however in their current state with significant economic and environmental impacts they are more of a burden then a capability. Market pressures and sustainability requirements soon will push companies even harder to convert this burden into a manufacturing capability. Purpose of this paper to investigate the value definition of changeovers, type of impacts and possible improvement opportunities from an industrial perspective. Due to the lack of data availability on changeover impacts in the current literature, a case-study was conducted through interviews and onsite observations. Current findings indicate that, changeovers may be considered as value adding in some cases. Moreover, from an environmental perspective water consumption, wastewater treatment, energy use, chemical use and product loss were the type of impacts that were frequently brought up, whereas loss of production time was highlighted as the main economic impact. Additionally, companies believe that both design and operational changes can provide improvements for their current systems. Current findings represent the issues within the type of industries included in this early stage of the study and therefore may change in the later stages of the project. This paper highlights important aspects of changeover operations that are commonly neglected in industrial practice while improvements towards these aspects could provide substantial economic benefits while improving companies’ environmental performance.

A unit manufacturing process is a fundamental operation unit in the manufacturing process of a mechanical product. It requires extensive knowledge of various processes to select a suitable unit process in process planning and manufacturing services. In the face of a large number of unit processes, it is very necessary to research and develop the knowledge representation and information processing approach for unit processes. In this paper, the basic unit manufacturing process concepts and relationships between them are analyzed in detail. The semantic Web technology is introduced into the knowledge modeling for unit processes, and a new ontology-based knowledge representation model is presented. A formalization for taxonomic semantics and descriptions of manufacturing capability knowledge is presented. A rule base that consists of a set of rules using Semantic Web Rule Language (SWRL) is built, which is used to enable reasoning on taxonomic semantics and manufacturing knowledge of unit processes. A knowledge retrieval approach that integrates Web Ontology Language (OWL) ontologies and SWRL rules is proposed. Some knowledge retrieval examples employing Semantic Query-enhanced Web Rule Language (SQWRL) are given. A knowledge prototype system for unit processes is developed. This research is a new attempt to construct an open, scalable, and shared manufacturing process knowledge system.

This paper presents the experimental evaluation method analysis of 3-axis filament winding machine performance. Winding circular test is a sufficient method to evaluate machine performance on winding circular repeatability and winding angle quality. It was concluded that the portable 3-axis filament winding machine had a good winding circular repeatability result, which offered 0.83–1.13 ​mm winding circular distance with 1.75–3.13% standard deviation. It was provided a good winding angle quality, which relied on 0.35–0.62° difference value with 2.25–8.68% standard deviation. It is indicated that winding circular test and winding angle measurement methods could be used as the experimental assessment to evaluate winding machine or relevant equipment on winding performance and manufacturing capability.

This study is about how does collaboration activities of large company's Supplier Relationship(SR) effect on manufacturing capability and performance of a SMEs. In this research, there are many ways to analyze data. The methods used in the study are hypothesis testing and empirical testing based on SPSS 21.0 and AMOS21.0, factorial analysis for validity and reliability of questionnaire item, construct validity and variance extracted as a research model, and subcontract-tiers as a moderating variable. As a result, the effect of the collaboration activities of large business did not have the significant effect on supplier's manufacturing capability. It showed different result by subcontract-tiers In first-tier cooperative, collaboration activities of large business had significant effect on manufacturing capability, but it did not have the significant effect on performance. In second/third-tier cooperative, manufacturing capability and performance are significantly affected by manufacturing practices. In conclusion, this study will suggest the direction how to achieve an accompanied growth between large enterprises and SMEs.

To accelerate the decarburization in the Indian power sector, concentrating solar power (CSP) needs to play an important role. CSP technologies have found significant space in the Jawaharlal Nehru National Solar Mission (JNNSM) of the Indian government in which 20,000 MW grid connected solar power projects have been targeted by 2022 with 50% capacity for CSP. In this study a preliminary attempt has been made to assess the potential of CSP generation in the Northwestern (NW) regions of India; which seems a high potential area as it has the highest annual solar radiation in India, favorable meteorological conditions for CSP and large amount of waste land. The potential of CSP systems in NW India is estimated on the basis of a detailed solar radiation and land resource assessment. The energy yield exercise has been carried out for the representative locations using System Advisor Model for four commercially available CSP technologies namely Parabolic Trough Collector (PTC), Central receiver system (CRS), Linear Fresnel Reflector (LFR) and Parabolic Dish System (PDS). The financial viability of CSP systems at different locations in NW India is also analyzed in this study. On the basis of a detailed solar radiation and land resource assessment, the maximum theoretical potential of CSP in NW India is estimated over 2000 GW taking into accounts the viability of different CSP technologies and land suitability criteria. The technical potential is estimated over 1700 GW at an annual direct normal incidence (DNI) over 1800 kW h/m 2 and finally, the economic potential is estimated over 700 GW at an annual DNI over 2000 kW h/m 2 in NW India. It is expected that in near future locations with lower DNI values could also become financially feasible with the development of new technologies, advancement of materials, economy of scale, manufacturing capability along with the enhanced policy measures etc. With an annual DNI over 1600 kW h/m 2 it is possible to exploit over 2000 GW CSP in the NW India.

International audience; The French 600 MWe Advanced Sodium Technological Reactor for Industrial Demonstration (ASTRID) project reached in 2015 the end of its conceptual design phase. The core design studies are being conducted by the CEA with support from AREVA NP and EDF. Innovative design choices for the core have been made to comply with the GEN IV reactor objectives, marking a breakthrough with the former Phenix and SuperPhenix Sodium Fast Reactors.One of the biggest challenges of the last five years was to propose a consistent design for the reflectors and neutron shielding sub-assemblies surrounding the fuel core in order to fulfill ASTRID requirements of minimising the secondary sodium activity level. Heavy iterative studies on both core and sub-assemblies were necessary to propose and evaluate different solutions following a strict value analysis process considering neutron shielding performances, life duration, maturity levels, washing and manufacturing capability, and qualification needs. Evaluated options were reflectors sub-assemblies made of steel or MgO rods, and radial neutron shielding sub-assemblies made of B$_4$C or borated steel, with different configurations in the design and in the core layout.This paper presents the iterative engineering studies, conducted by CEA and performed by AREVA NP, concerning the radial shielding sub-assemblies for ASTRID core, from the selection of possible solutions to a final consistent conceptual design.