Lack Of International Standards Research Articles

International standards for monoclonal antibodies for assessing the biological activity of medicines: A status update

Scientific relevance. The clinical effects and the expiration of patents for original (reference) biotechnological medicines based on monoclonal antibodies (mAbs) stimulated the development of biosimilar mAbs. The quality profile of a biosimilar mAb should correspond to the quality of the reference medicinal product. When demonstrating biosimilarity and determining the activity of medicines as part of batch quality control, analysts should study the biological properties of mAbs using suitable reference standards. The lack of international standards (ISs) makes mAb manufacturers use in-house reference standards. There is a risk of obtaining non-uniform quality and efficacy data because of the use of in-house reference standards, the heterogeneity and structural complexity of mAbs, and the relationship between the biological activity and efficacy of mAbs.Aim. This study aimed to analyse the relevance of and need for ISs for the biological activity of biotherapeutic mAbs and to define the role of reference medicinal products and ISs in assessing biosimilarity and testing medicines throughout their lifecycle.Discussion. This review covers the issues arising from the lack of ISs for assessing the biological activity of mAbs and the role and significance of reference products and ISs for biosimilars. The authors describe the specifics of studying the biological properties of mAbs and summarise the data on the need to develop and use ISs for the standardisation of biological tests. This review presents the results of studies on the first ISs established by the World Health Organisation to assess the biological activity of mAbs; these results suggest the need to standardise mAbs using ISs to ensure the quality, safety, and efficacy of mAb therapy.Conclusions. The use of ISs for mAbs plays a key role in harmonising biological activity assessments. Publicly available ISs serve as primary standards for the calibration of secondary reference materials. Moreover, ISs are required for the harmonisation of activity evaluation (in IU) between laboratories and for the consistency of the activity of various medicinal products from different manufacturers that share the same INN. The use of ISs by mAb manufacturers will contribute to ensuring the quality of mAbs and clinical monitoring of the effectiveness of their use.

What are the challenges for implementing an "organic label" to camel milk?

Increasing demand for camel's milk worldwide occurred in the context of the development of the organic sector in agriculture. The implementation of an organic label for camel milk has never been established. However, the creation of such a label faces to important challenges that are investigated in the present paper. Indeed, although camel milk conveys the image of a "natural product" issued from remote places, the risk of being produced in contaminated areas (mining activities, oil extraction) cannot be neglected for grazing animals. Moreover, the management of veterinary drugs for prevention or curative treatment can lead to the presence of residues in milk, especially in camel species with different pharmacokinetics, although similar instructions than for cow milk are used. Moreover, the lack of international standards regarding both composition and hygienic rules, the risks of adulteration, and the necessity to use specific indicators or analytical procedures adapted to the behavior of camel milk, have to be taken in account in the establishment of the specifications for the camel milk producers through the world.

On the importance of multi-material acceptance testing for CT-based CMSs

As the use of multi-material objects in industry continues to rise, the need for geometrical quality control by means of computed tomography-based coordinate measurement systems (CT-based CMSs) for entire geometries is rising as well. But the lack of international standards and the limited knowledge available on the influence of multi-materials on dimensional CT measurements greatly impairs the reliability of this technology. Therefore this paper, after summarising the multi-material effects on dimensional CT measurements, will evaluate the performance of a metrology CT system for multi-material measurements. The objectives here are to gather evidence for and to better understand the multi-material influence on CT measurements. The investigation consisted of carrying out test measurements similar to standardised acceptance test measurements using a set of dedicated multi-material reference standards. The evaluation of the measurement results relied on statistical analyses and estimation of the test value uncertainty. This evaluation has validated that effects not present in mono-material measurements indeed exist in multi-material measurements, thus highlighting the importance of considering multi-material effects on dimensional CT measurements.

An author level metrics of scholarly impact journals; cited through Google Scholar Source

As academic journals have become more digital, scientific writers now have more chances to increase the visibility of their research and its citations globally. The metrics is the gold standard. It is used to decide the ranking and benchmark of the journals which will be determined using bibliometrics and different algorithms. Numerous predatory journals are lack of international standards and low quality. Authors will be unable to submit their research papers or reports to the journals for publication with a high impact factor in this circumstance. The main objective of this study is to focus on identifying the global citations by investigating the author level metrics of the top hundred scholarly publications. Data were gathered from Google Scholar source between January 2021 and September 2022 for the study, which was quantitative in nature. Hypothesis was tested by simulation growth model and statistically approximates the h5 citation and Journal impact factor. Asper the results, top hundred first ranking was seen in Nature Reviews and Molecular Cell Biology (h5 155, IF 113.90 h5 median 340) followed by nature reviews immunology (h5 152, IF 108.60 h5 median 292), The highest ranking discipline that was substantially correlated with citation was health and medical sciences (r = 0.91, R2 % = 0.97) followed by physics and mathematics (r = 0.89, R2 % = 0.94).Finally, this study implies that open access journals should have display metrics information for the researchers which can be act as formidable tool for the publishers, scientists and researchers enabling them to make informed decisions at the appropriate moment and disseminate scientific knowledge globally.

무역원활화를 위한 전자무역서비스 개선방안

As the world trade environment and business environment change, the importance of trade facilitation is being emphasized. In this regard, Korea has also been striving to facilitate trade through the establishment of e-trade services. However, the e-trade service for trade facilitation still does not fully perform its functions due to overlapping roles, inadequacy of laws and systems, and lack of international standards. Therefore, the improvement plan of e-trade service for trade facilitation is considered as follows. First, it is necessary to establish a prompt and efficient operating system by unifying the entities that promote trade facilitation. Second, an international single-window system must be established through the advancement of UNI-PASS. Third, it is necessary to establish an integrated support service by reconfiguring the role of uTradeHub. Through this, it is necessary to enhance the service utilization of trading companies for trade facilitation.

A Critical Review of Renewable Hydrogen Production Methods: Factors Affecting Their Scale-Up and Its Role in Future Energy Generation.

An increase in human activities and population growth have significantly increased the world’s energy demands. The major source of energy for the world today is from fossil fuels, which are polluting and degrading the environment due to the emission of greenhouse gases. Hydrogen is an identified efficient energy carrier and can be obtained through renewable and non-renewable sources. An overview of renewable sources of hydrogen production which focuses on water splitting (electrolysis, thermolysis, and photolysis) and biomass (biological and thermochemical) mechanisms is presented in this study. The limitations associated with these mechanisms are discussed. The study also looks at some critical factors that hinders the scaling up of the hydrogen economy globally. Key among these factors are issues relating to the absence of a value chain for clean hydrogen, storage and transportation of hydrogen, high cost of production, lack of international standards, and risks in investment. The study ends with some future research recommendations for researchers to help enhance the technical efficiencies of some production mechanisms, and policy direction to governments to reduce investment risks in the sector to scale the hydrogen economy up.

Business of rural tourist households in the function of rural tourism development in Serbia

The main goal of the paper is, based on research and analysis of the material base and tourist turnover of rural tourist households (RTHs), in the period from 2014 to 2019, to point out to the dynamics of development and the current level of development and utilization of the tourist offer of this sector in Serbia. Quantitative data on accommodation facilities in rural areas of the Republic of Serbia in six years period (2014-2019) are analyzed. In addition to research, various scientific methods were used: the inductive-deductive method, the method of analysis and synthesis and the method of observation. Based on the analysis of quantitative and qualitative aspects of supply it was concluded that a lack of international standards and quality guarantees was noticed, as well as problems related to adaptation, registration and categorization of the RTHs, which confirmed the basic research hypothesis.

Social Organizational Life Cycle Assessment (SO-LCA) and Organization 4.0: An easy-to-implement method

Organizations often face difficulties when measuring their social performance. The lack of international standards, the qualitative/quantitative nature of data, and the unavailability of primary sources all hinder social impact assessments, especially in manufacturing settings. To fill these gaps, the method proposes a simple application protocol of Social Organizational Life Cycle Assessment (SO-LCA), customized for an Italian ceramic tile manufacturer. The method leverages Industry 4.0 digital technologies to collect real-time primary and site-specific social data, making the social assessment dynamic. The managerial approach adopted for the selection of social metrics and weighting of indicators and indexes, can support the transition of the manufacturing organization into Organization 4.0. The method also provides a contribution to the operational validation of the UNEP guidelines by extending their area of application. Finally, the proposed method gives substance to social responsibility through social accounting, helping the organization to measure the correct social impact starting from the detailed data, namely the decisions made in the business and in production.•Social Organizational Life Cycle Assessment (SO-LCA) application protocol validated in Industry 4.0 environment.•Social metrics directly linked to production and business processes for the dynamic assessment of social performance.•Easy replicability of the method in other organizational contexts.

Innovative technologies in food production processes

The article presents the development of the agro-industrial complex taking into account innovations in the field of digitalization of technological processes of the food industry. The tasks of digitalization, the evolution of the industry are described, digital technologies introduced into the processes of the food industry, the introduction of smart production, Big Data technologies, machine vision, additive technologies are listed. Examples of the introduction of digital technologies in different countries are shown. The factors limiting the introduction of digital technologies, lack of personnel, unstable economy, psychological and organizational factors, and lack of international standards in the field of digital transformation are shown. Production statistics are widely used to identify bottlenecks in production, search for hidden reserves and determine the reasons for reducing the efficiency of equipment. Blockchain technologies are beginning to be used in the production of food. Distributed registry systems help to increase the transparency of all stages. Successful implementation requires the interest of all participants in the production chain (from the farmer to the consumer). Digital transformation in Russia began to pay serious attention relatively recently, most of the projects are under implementation. Various innovations introduced in the food production and the food industry are reflected.

Sustainable Shift from Centralized to Participatory Higher Education in Post-Soviet Countries: A Systematic Literature Review

Since the fall of the Soviet Union, higher education (HE) in post-Soviet reality continues to face complex challenges, including hierarchical structures, antiquated teaching methods, and lack of international standards. In the meantime, in the US and in Europe, HE has recently focused on participatory curriculum development (PCD) and programs that seek to directly connect student learning to “real-world” problems, accelerating positive change in curricula and through their contributions to regional communities. Accepted into the Bologna Process—the standardization of European HE—Armenian HE institutions struggle to satisfy requirements and related sustainable development goals with centralized standards, inhibiting them from being internationally competitive and regional sustainability change agents. In this article, we examine post-Soviet HE development since 1991 and challenges, with a particular focus on Armenia; what participatory curriculum building may offer; and how it contributes to HE and regional sustainability transitions. A systematic literature review was applied, using specific combinations of important terms restricting the search with criteria such as language, year of publication, and descriptive or critical in nature. The results illustrate the status quo of post-Soviet HE, synthesize current barriers of HE as potential change agents, and highlight PCD as a way to overcome these barriers.

Regulatory Cooperation in Securities Market Regulation: Perspectives from Australia

The global financial crisis highlighted the interconnectedness of international financial markets and the risk of contagion it posed. The crisis also emphasized the importance of supranational regulation and regulatory cooperation to address that risk. Yet, although capital flows are global, securities regulation is not. As a 2019 report by IOSCO notes, the regulatory challenges revealed during the global financial crisis have by no means dissipated over the last decade. Lack of international standards, or differences in the way jurisdictions implement such standards, can often result in regulatory-driven market fragmentation. This article considers a range of cooperative techniques designed to achieve international regulatory harmonization and effective cross-border financial market supervision. It discusses three major techniques: (i) transgovernmental networks of financial regulators; (ii) complex multilateral arrangements; and (iii) mutual recognition agreements, and considers the benefits and downsides of each of these regulatory mechanisms. The article focuses particularly on developments in Australia. It examines, for example, a high profile cross-border supervisory experiment, the US-Australian Mutual Recognition Agreement, which the SEC and Australia’s business conduct regulator, ASIC, signed in 2008. This was the first agreement of its kind for the SEC. The article also considers some key regulatory developments in Australia and Asia since the time of the US-Australian Mutual Recognition Agreement.

Regulatory Cooperation in Securities Market Regulation: Perspectives from Australia

The global financial crisis highlighted the interconnectedness of international financial markets and the risk of contagion it posed. The crisis also emphasized the importance of supranational regulation and regulatory cooperation to address that risk. Yet, although capital flows are global, securities regulation is not. As a 2019 report by IOSCO notes, the regulatory challenges revealed during the global financial crisis have by no means dissipated over the last decade. Lack of international standards, or differences in the way jurisdictions implement such standards, can often result in regulatory-driven market fragmentation. This article considers a range of cooperative techniques designed to achieve international regulatory harmonization and effective financial market supervision. It includes discussion of a high profile cross-border supervisory experiment, the 2008 US-Australian Mutual Recognition Agreement, which was the first agreement of its kind for the SEC. The article also examines some key regulatory developments in Australia and Asia since the time of the US-Australian Mutual Recognition Agreement.

The Ethical Necessities and Principles in Telerehabilitation

With the increase in technological developments, the use of technological applications in health services has increased. Telerehabilitation is one of the technological applications used in rehabilitation services. The application of telerehabilitation practices within the framework of ethical principles is of great importance for the protection of patient privacy. The lack of international standards on the ethics of telerehabilitation and the lack of applicable legal provisions is one of the major obstacles to the effective use and widespread use of these practices. In order to prevent the use of these practices that provide cost, time and ease of use to produce negative results, ethical principles should be clearly defined and handled with the laws. In this review, ethical principles that should be taken into consideration in telerehabilitation applications are discussed and how possible violations of rules can have consequences.

A practical guide to the preparation and use of metal ion-buffered systems for physiological research.

Recent recognition that mobile pools of Zn2+ and Cu2+ are involved in the regulation of neuronal, endocrine and other cells has stimulated the development of tools to visualize and quantify the level of free trace metal ions. Most of the methods used to measure or control loosely bound metals require reference media that contain exactly defined free concentrations of the target ions. Despite the central importance of proper metal ion buffering, there is still a lack of international standards and beginners in the field may have difficulties finding a coherent description of how to prepare trace metal ion buffers, especially when experiments are to be performed in multimetal systems. To close this gap, we provide a guide for the design, preparation and use of metal ion-buffered systems that facilitate immediate application under physiologically relevant ionic conditions. Thermodynamic and kinetic concepts of chemical speciation as well as general protocols and specific examples are outlined for the accurate preparation of single- and dual-metal ion buffers. In addition, experiments have been performed with FluoZin-3 to illustrate that metal ion-buffered systems are required for reliable preparation of nanomolar Zn2+ solutions and that dual-metal ion buffers can be used to calibrate suitable fluorescent Zn2+ sensors in the presence of millimolar Ca2+ concentrations. Together, the information provided should sensitize readers to the many potential pitfalls and uncertainties that exist when working with physiologically relevant concentrations of trace metal ions and enable them to formulate their own metal ion buffers for most invitro applications.

Experience of data collection in support of the assessment of global progress in the Sendai Framework for Disaster Risk Reduction 2015–2030 – A Swedish pilot study

Most countries collect loss and damage data after disasters for learning purposes and in support of future preventive work. The lack of international standards and sharing principles implies heterogeneous data sets, thus presenting a challenge to the development of indicators intended to assess progress within the UN agreement Sendai Framework for Disaster Risk Reduction 2015–2030 (SFDRR). In this study, data on mortality, affected people and direct economic losses are extracted from two national databases in Sweden for the years 1996–2015. Pre-SFDRR terminology, definitions and different inclusion criteria are used to exemplify and identify challenges when global “proxy” data inquiry clashes with sub-national demands for data quality. Different test methods on how to estimate affected people are used and in comparison with the term ‘directly affected people’, as proposed in the SFDRR indicator establishment process, it is concluded that methods for more disaggregated data are needed. In a Swedish context, the SFDRR call for a reference period 2005–2015 is found to be a time too short for providing a fair picture of disaster risks within Sweden's borders. The nationally developed strategy in Sweden, as in many other countries, to learn in-depth after each new disaster and use the experience to remedy weaknesses in safety systems, generates solid data supporting the development of SFDRR indicators, but the national benefits and the relevance of statistics from disasters re-occurring on longer time scales are limited.

ПРОБЛЕМЫ “ЗЕЛЕНОГО” ФИНАНСИРОВАНИЯ В СТРАНАХ G20

Financial support for transition to sustainable social and economic development is one of the major challenges for most of G20 countries. To complete this task, key stakeholders have to overcome multiple barriers. According to international experts, several challenges are recognized as top priorities. Without addressing them G20 countries might not succeed in bridging the increasing financial gap between the needs of green economy and currently available investment opportunities. Such challenges are analyzed in the article. Among them are: 1) absence of common definition of green finance and lack of international standards; 2) insufficient correlation of targets of sustainable growth with priorities of national investment policy; 3) absence of regulatory and legal framework directly related to green finance; 4) ecological externalities; 5) maturity mismatch; 6) poor green project selection and management; 7) information asymmetry at the capital markets; 8) lack of analytical tools and expertise in identification and assessment of green projects’ risks. The authors explain how each of the considered challenges hampers realization of green financing potential and analyze the best practice in addressing them. It is stated that solution of the abovementioned problems requires strong support from the governments of the G20 countries. At present, these countries implement such measures, as: introduction of appropriate regulatory and legal framework, stimulation of development market mechanisms and instruments of green financing (green bonds, credits, indices, etc.), formation of conditions aimed at elimination of asymmetry of information, fostering private-public partnership. Development of new international standards aligned with the requirements of sustainable growth and green financing is also under way in G20 countries. It is also noted that several challenges (namely, environmental externalities and green projects’ risk evaluation) require additional efforts from G20 countries, both at the national and global levels. Acknowledgements. The article has been supported by the Ministry of Finance of the Russian Federation within a research project “Practical support for green financing (based on the G20 countries’ best practice)”.

Is a Global Solution Possible to the Technology/Privacy Conundrum

In crafting new paradigms to balance the often competing demands of technological advancement and privacy, it is critical to treat the issue from an international perspective. Differences in politics, culture and even views regarding the benefits of certain technological advances argue against the creation of a truly universal paradigm. Using the differing treatment of individual privacy and service provider liability as analytical paradigms, this article contends that the lack of international standards at this time might not be so problematic as appears at first glance. Regulation before a particular technology is understood can result in over- or under- protection of privacy rights. Moreover, the present lack of international standards allows for greater experimentation in crafting acceptable boundaries in privacy protection, including, critically, focusing on greater consumer awareness of the intersections between technology and privacy. The international implications of the intersections between technology and privacy will only continue to grow. Part of the solution is to begin to create an international dialogue with a goal to establishing a middle ground and to include multinational organizations as part of the dialogue.

Importance of interchangeability for urban guided transport equipment

The European Union wishes to develop strategies to increase the number of urban transport passengers over the coming years. Urban transport is the key transport mode for the decrease of congestion, pollution, energy consumption and limitation of land use by transport in cities. Urban areas are the drivers of the European economy. This implication of European authorities rests on the means mobilised in European research projects. These research projects aim at conceiving the common model of the future safe and interchangeable guided transport systems in Europe and highlights the problems related to the harmonisation of the steps of safety certification of such systems. Therefore, the concept of interchangeability ((UGTMS), (MODURBAN)), is important and, it means that system components can be produced from any suppliers and replaced without any substantial change in functionality or performance. It also allows the system to adapt to technology evolutions without significant modifications to its architecture. The main barriers for reaching these objectives are the complexity of the existing systems, the diversity of national legislation and the lack of international standards. The common model of this framework is needed to open the competitive market for urban transport.

What Is A Well?

Guest editorial Over the past decade, well technology has advanced exponentially. Horizontal wells, multiple completions, and wells that cycle between steam injection and heavy oil production have superseded the traditional vertical well with one completion zone. Advances in the way the oil and gas sector describes and identifies well data elements have not matched the growth in well technology, however. Even the way the sector defines basic well concepts, such as wellbores, completions, and depths, can vary between companies and regulatory jurisdictions. Several factors have contributed to that inconsistency. The foundation for regulations and well technology dates back more than a century: many terminologies arose when the petroleum sector was in its infancy. Drilling technology has changed dramatically in the past 10 years, yet the regulatory descriptions have remained relatively static. Part of the reason is the lack of international standards; for many years, guidance was offered by the American Petroleum Institute in the US, but lapsed in the 1980s. The myriad of modern drilling techniques also add to the confusion. Start with a simple producing well, which is wellbore WB1 (Fig. 1). Later, when the operator deepens the well (WB2) and completes new formations (WB2-C1 and WB2-C2), there is some disagreement about whether the deepened segment is part of the same wellbore, or a new wellbore. Of those who think it is a new wellbore, some measure the new wellbore from the surface to the new bottom hole, and some think the new wellbore is only the newly drilled portion. Many modern wells have far more complex production histories. In Fig. 2, the operator has drilled a pilot well, WB1, with two lateral segments, WB2 and WB3, which are then completed in separate reservoirs. Knowing which production exists in which wellbores becomes far more important; an engineering decision made on incorrect or incomplete information has the potential to create significant repercussions. In Search of a Solution The Professional Petroleum Data Management Association (PPDM), based in Calgary, has been working to resolve the issue. PPDM was formed in 1989 and incorporated in 1991. It is a not-for-profit organization that provides data management expertise for the petroleum exploration and production industry. The membership is made up of more than 150 petroleum companies, government agencies, software application providers, data vendors, and service companies. The petroleum industry generates a large amount of data, including exploration seismic, well drilling, and oil and gas production information. PPDM originally set out to develop an open data model that would allow the industry to reduce costs and allow companies to become more productive, efficient, and competitive. Over the past two decades, industry professionals working as volunteers with PPDM have created a comprehensive data model that benefits a wide array of functions within an oil company, such as well information, surface and mineral rights management, well activities and operations, equipment and facilities management, seismic information, and production and reserves data.

Letter to the Editor

The explosive increase since the beginning of the 1990s in the number of publications reporting PCR-based methods for detection or molecular typing of foodborne pathogens has attracted the attention of end-user laboratories. However, the well-recognized difficulties in reproducing published tests because of variation in performance of PCR thermal cyclers (Schoder et al. 2003), in efficiency of different DNA polymerases, and in the presence of PCR inhibitors in the sample matrix, have hampered implementation in end-user laboratories. This particularly applies to laboratories with quality-assurance programmes. It is necessary to have PCR-based methods available as internationally recognized standards (Hoorfar and Cook 2002). Currently, lack of international standards often forces end-user laboratories to spend substantial resources on adaptation of the published tests. Although many commercial PCR kits are available, it is important that end-users and reference laboratories have access to open-formula, noncommercial and nonproprietary PCRs in which the information on target gene and reagents are fully available. The prerequisite for a PCR, published in the scientific literature, to be adopted as a standard is that it has to be nonproprietary, and to have been validated through multicentre collaborative trial according to the international criteria (Anon. 2001, 2002a; Hoorfar and Cook 2002). Multicentre trial validation of noncommercial PCRs for detection of zoonotic pathogens has been performed by a European validation and standardization project (FOOD-PCR: http://www.pcr.dk) involving 35 laboratories from 21 countries (Hoorfar 1999; Malorny et al. 2003). A major drawback of most published PCRs, surprisingly even to date, is that they do not contain an internal amplification control (IAC). An IAC is a nontarget DNA sequence present in the same sample reaction tube, which is co-amplified simultaneously with the target sequence. In a PCR without an IAC, a negative response (no band or signal) can mean that there was no target sequence present in the reaction. But, it could also mean that the reaction was inhibited, as a result of malfunction of thermal cycler, incorrect PCR mixture, poor polymerase activity and, not least, the presence of inhibitory substances in the sample matrix. Conversely, in a PCR with an IAC, a control signal will always be produced when there is no target sequence present. When neither IAC signal nor target signal is produced, the PCR reaction fails. Thus, when using a PCR-based method in routine analysis, an IAC, if the concentration adjusted correctly, will indicate false-negative results. It is the false-negative results that turn a risk into a threat for the population, whereas a false-positive result merely leads to a clarification of the presumptive results by re-testing the sample. The European Standardization Committee (CEN), in collaboration with International Standard Organization (ISO) has proposed a general guideline for PCR testing that requires the presence of IAC in the reaction mixture (Anon. 2002b). Therefore, only IAC-containing PCRs may undergo multicentre collaborative trials, which is a prerequisite for standardization. Scientific journals must provide the source of new PCR-based methods suitable for standardization. Therefore, we propose that henceforward the editorial boards of applied microbiology journals require inclusion of an IAC in diagnostic PCR reported in submitted manuscripts. This could be performed by providing a specific section devoted to PCR in their Instruction to Authors.