Organizational Requirements Research Articles

Open Innovation and Regulatory Challenges in New Modality Development: The Pivotal Role of Contract Development and Manufacturing Organisations in Advancing Antibody Drugs.

Ensuring regulatory-compliant manufacturing capability is an essential challenge for new treatment modalities, but its internalisation is not easy for pharmaceutical companies, especially start-ups. This study examines the functions and requirements of contracted development and manufacturing organisations (CDMOs) using the development process of antibody medicines as a case study. Utilizing PubMed, Cortellis and Patent Integration databases, this study delves into publication and contractual trends in monoclonal antibody drugs (mAbs) development, alongside an analysis of patent filings by CDMOs, offering a comprehensive overview of the evolving landscape in mAbs innovation. In the early stages of mAbs development, dedicated bio firms (DBFs) led R&D with superior drug discovery technology but lacked manufacturing capability, which was complemented by CDMOs. This collaboration was an opportunity for CDMOs to expand their capabilities beyond manufacturing technology into antibody drug candidate discovery and structural optimisation technology. From mid-development onwards, it established a technology platform based on these capabilities and developed and established partnerships with existing pharmaceutical companies, including mega pharma. The impact of institutions and regulations on the innovation process was assessed during this development process. These findings are expected to provide valuable insights into the innovation system for new modalities.

Factors influencing physical activity and sedentary behaviour in contact centres during the COVID-19 pandemic and their relevance for the future of hybrid working.

The COVID-19 pandemic changed the way many industries work, including contact centres, with some employees working from home and new on-site restrictions/measures in place representing even greater challenges for employers around staff engagement and wellbeing. This study aimed to understand the interplay of individual, social, environmental and organisational factors influencing physical activity and sedentary behaviour in UK contact centre employees, how the pandemic impacted these factors, and their relevance for the future of hybrid working. Individual interviews (n = 33) were conducted with participants (staff working full and part time, on site and from home) from four UK contact centres. A topic guide based on the ecological model was developed to understand current barriers and facilitators to physical activity and (reducing) sedentary behaviour during and outside of working hours. Thematic analysis was carried out using a codebook and a deductive coding approach to identify themes. Three key insights are provided. First, participants felt they were generally sitting more and moving less since the first UK-wide lockdown. Second, factors which negatively impacted on these behaviours were evident across all levels of the ecological model. These included individual and social barriers (e.g., lack of motivation and preferable physical activity options) as well as environmental and organisational barriers (e.g., poor home office setup, back-to-back virtual meetings). There were a mix of new and existing barriers (exacerbated by the pandemic) and several of these were linked to homeworking. Third, organisational support requirements (e.g., homeworking ergonomic support) and existing facilitators (such as the provision of informational support and flexible working arrangements) were identified. Solutions to reduce sedentary behaviours and increase physical activity in contact centres need to address barriers from the individual to the organisational level. Whilst the study was undertaken in the UK, the results are like to be applicable globally. Clinical trial registration: The trial for the wider project has been registered on the ISRCTN database: http://www.isrctn.com/ISRCTN11580369.

‘I would work with a client, but I have to fill out papers’: understanding professional roles and role conflicts experienced by Lithuanian probation officers

This article aims to explore the roles that Lithuanian probation officers associate with their profession, the differences between their ideal and actual roles, and the conflicts they encounter in their daily work with probation clients. The research was conducted using both quantitative and qualitative methods, including a survey of 129 individuals and interviews with 20 probation officers. Results from the survey showed that Lithuanian probation officers tend to associate their profession with control and balancing roles. Interviews revealed that probation officers associate their ideal roles with control or resocialisation functions but accept these contrasting roles as a professional necessity. The study also found that probation officers face a high workload related to paperwork, which suggests an actual role as a bureaucrat. Nevertheless, this role is not desired by the officers and is rejected. Additionally, the study revealed that probation officers experience internal conflicts related to the different expectations of their clients and the management of the probation service. This article argues that the organisation's attitude and requirements influence the gap between the ideal and actual roles of probation officers and orient their actual roles towards bureaucratic and control functions.

Integration of Inventory Data from Cohort and Registry Studies into an Existing Research Network: National Pandemic Cohort Network (NAPKON)

In the early phase of the COVID-19 pandemic, many local collections of clinical data on patients infected with SARS-CoV-2 were initiated in Germany. As part of the National Pandemic Cohort Network (NAPKON) of the University Medicine Network, the "Integration Core" was established to design the legal, technical and organisational requirements for the integration of inventory data into ongoing prospective data collections and to test the feasibility of the newly developed solutions using use cases (UCs). Detailed study documents of the data collections were obtained. After structured document analysis, a review board evaluated the integrability of the data in NAPKON according to defined criteria. Of 30 university hospitals contacted, 20 responded to the request. Patient information and consent showed a heterogeneous picture with regard to the pseudonymised transfer of data to third parties and re-contact. The majority of the data collections (n=13) met the criteria for integration into NAPKON; four studies would require adjustments to the regulatory documents. Three cohorts were not suitable for inclusion in NAPKON. The legal framework for retrospective data integration and consent-free data use via research clauses (§27 BDSG) was elaborated by a legal opinion by TMF - Technology, Methods and Infrastructure for Networked Medical Research, Berlin. Two UCs selected by the NAPKON steering committee (CORKUM, LMU Munich; Pa-COVID-19, Charité- Universitätsmedizin Berlin) were used to demonstrate the feasibility of data integration in NAPKON by the end of 2021. Quality assurance and performance-based reimbursement of the cases were carried out according to the specifications. Based on the results, recommendations can be formulated for various contexts in order to create technical-operational prerequisites such as interoperability, interfaces and data models for data integration and to fulfil regulatory requirements on ethics, data protection, medical confidentiality and data access when integrating existing cohort data. The possible integration of data into research networks and their secondary use should be taken into account as early as the planning phase of a study - particularly with regard to informed consent - in order to maximise the benefits of the data collected.

Enhance Key Stage Generation for Developing Kasumi Encryption Algorithm

Today, data security is a critical component of the efficient performance of every organization's diverse requirement, one of the important requirements is to provide a secure connection for data transmission in organization's networks. Cryptography algorithms are used to protect transmitted data from unauthorized access. Every day, a great deal of research is being done. The process of encrypting data is currently under development. Therefore, a substantial technological or research effort is still required. Cellular networks and secure communication. This proposal calls for the development of a new encryption system based on Using random keys in all the rounds. That’s mean we generated random keys as 128 bits for each round and save it in an array with size (8×8) because we have 8 rounds and each key divided into 8 sub keys as 16 bits for each to use in encryption and decryption. The developed random keys and traditional algorithm keys were tested with statistical tests of NIST, which made up a comparison and conclusion that the developed keys have a higher randomness specially in linear complexity, Frequency within block and random excursion tests, which leads to a better quality of encryption. Then we could test the cipher text with frequency within block test that was evaluated by (0.49590998713105255) and the approximate entropy test that was evaluated by (0.4922198616875501) for each cipher text which resulted from standard and modified Kasumi algorithm that’s means we can conclude that our modified Kasumi algorithm achieved more secure data in its resulted cipher text.

Elevating the competitiveness of general education schools: Perspectives from experts and educational leaders

Education is the cornerstone of development in all its forms. Therefore, the continuous improvement of education is a fundamental necessity pursued by societies to ensure progress and advancement. Schools are the fundamental pillars for the development and growth of society in all areas, and education is the path to progress and prosperity. This study aims to uncover the essential requirements and expected challenges to enhance the competitiveness of Omani public education schools from the perspectives of educational leaders and experts. A qualitative approach was employed in collecting and analyzing the data. The study sample consisted of 43 experts and educational leaders from the Ministry of Education and Omani universities, including 19 working in higher education and 24 in the public education sector. The data gathered through semi-structured interviews centered on two main themes: the requirements and the expected challenges. The study revealed a list of requirements to enhance competitiveness in the areas of administrative, cognitive, human, and organizational requirements. It also identified the prominent expected challenges.

What Are the Challenges Ahead for Training the Present and Next-Generation Microscopists in the Life Sciences (a.k.a. Structural Cell Biologists)?

Abstract Becoming a life scientist microscopist involves earning a bachelor’s degree in biology, biomedicine, or a related education program, specializing in microscopy-related areas. Advanced degrees (B.A. Hons., M.A. Res., or Ph.D.) enhance hands-on proficiencies and lay the foundation to become a microscopist or structural cell biologist. Staying updated on technological advancements, networking, and attending relevant microscopy conferences and workshops are central to the success of becoming an established, competent microscopist. Building an academic career in microscopy includes showcasing skills and proficiency in a research field. This involves teaching, scholarly dissemination, and achieving success in awards and grants, which are crucial for entry-level positions in academia. Continuous professional development in specific microscopy interests through workshops, self-education, online resources, or attaining additional certificates or diplomas is essential for academic career advancement, as the science of microscopy is not characterized by a status quo but is evolving at unprecedented speed. Tailoring education and understanding job requirements for academia, research organizations, or industry are critical decisions to align skills with career goals. In this themed contribution, we highlight key considerations for aspiring or junior microscopists to contemplate when building a successful research career in biological microscopy.

Agro-Pastoral Youth Participation in Livelihood Activities, Development Programs and Interventions in East and West Hararghe Zones of Oromia Regional State, Ethiopia

This study was conducted to identify the status and determinants of male and female youth participation in selected livelihood activities, development programs and interventions in agro-pastoral areas of Oromia regional state, Ethiopia. A cross-sectional research design and mixed methods research approach were employed. A multi-stage random sampling strategy was followed to select four agro-pastoral Woredas (A ‘Woreda’ is an administrative unit equivalent to a District), 12 Kebeles (A ‘Kebele’ is the smallest administrative unit in Ethiopia. A Woreda/District consists of several Kebeles) and 398 youth aged 15–29 years for a face-to-face interview. Data were analysed through descriptive and inferential statistics and an econometric model (Logistic regression) estimation. We found that whereas male youth had better access to land, participation in extension/advisory services and Farmers’ Training Centers (FTCs), agricultural training, and NGOs, female youth had better participation in non-/off-farm livelihood activities and Productive Safety Net Program (PSNP). Our findings indicated that lack of access to financial resources, limited access to land, poor extension and rural advisory services, limited skills development programs and mentorship were key factors affecting youth participation. Other factors include: targeting criteria, discrimination (e.g. on the basis of gender, social structure), cumbersome organizational procedures and requirements, limited availability and capacity of supporting organizations, poor infrastructural developments, mismatch between needs and services provided, conflict, and climate-induced shocks and uncertainties. To overcome these challenges, local and regional governments and their development partners operating in the area should implement a multi-stakeholder, participatory, co-design and development of programs, projects and interventions to enhance collaboration, youth engagement and benefit. Investments in capacity-building and alternative income-generating activities, entrepreneurship education and business skills training are also important.

A Clean You Can Trust: Using an Evidence-Based Bundle to Transform Point-of-Use Treatment for Reusable Medical Devices at a Military Treatment Facility

ABSTRACT Introduction Throughout surgical and invasive procedures, reusable instruments and flexible endoscopes become soiled with organic and inorganic materials. When these substances are permitted to dry, a matrix of microbial cells, called biofilm, forms on the surface of devices, irreversibly binding and subsequently impeding the disinfection and sterilization process. To prevent biofilm formation from occurring, devices must be continuously flushed and wiped with water throughout the procedure and at the end of the case. This process, known as point-of-use treatment (POUT), is the critical first step in the decontamination of medical devices. Poor compliance with POUT can increase patient morbidity and mortality and result in failing hospital accreditation. Materials and Methods An interdisciplinary team used the Plan-Do-Study-Act (PDSA) to develop and implement an audit assessing 29 evidence-based criteria for POUT treatment. Each PDSA cycle supported evidence-based opportunities addressing feedback, workflow analysis, policy development, competency assessment creation, training module development, and infection prevention grand rounds. Four audits were performed over ten months to achieve improved organizational POUT compliance. Results Implementing recurrent PDSA cycles that included audits with feedback led to an evidence-based bundle of policies, competencies, and training for 34 different clinical areas. These interventions resulted in a 26% compliance increase (66% to 92%). Program-specific improvements included flexible endoscopes (+4%) and reusable instruments (+20%). Conclusions Multimodal evidence-based initiatives to improve compliance with workflow processes is a translatable POUT evidence-based practice project for similar Defense Health Agengy facilities. Workflow processes can be vetted and distributed using interdisciplinary teams to ensure viability, sustainability, and conformity with organizational requirements, resulting in a more ready force.

Экспертиза результатов подрядных работ, произведённых для нужд системы МВД России: проблемы правовой регламентации

The article considers the existing gaps in the legal regulation of expert examination of the results of contractual work performed under the state contract. In this regard, the author substantiates and proposes a unified legal mechanism for the implementation of expert examination of the results of contractual work performed for the needs of the system of the Ministry of Internal Affairs of Russia. The basis of this mechanism should be a departmental normative legal act regulating the order of delivery and acceptance of contract works; procedure for examination and selection of external and internal experts, third-party expert organizations; cases of internal and external expert examination; establishing qualification requirements for internal experts, independent experts and expert organizations; standard forms of internal expert report and act of delivery and acceptance of the results of contract works.

The role of digital arbitration in the resolution of electronic commerce disputes between the necessity of application and the imperative of confrontation

The world has recently undergone a major shift in international information technology, software and communications, which has been regarded as a global revolution in many areas. and transformed traditional means of commercial transactions into electronic means of communication through the promotion, exchange and completion of transactions of goods using modern telecommunications and information exchange technology without the parties meeting in one place, Whether mutual commitments can be implemented electronically or require concrete physical implementation which created for us e-commerce that has become a reality of a real pension, It is also one of the economic pillars of the State and an important mechanism for raising productivity. This necessitates the provision of the appropriate legal environment and the search for means to ensure that they are controlled within a systematic and regulated legal framework, In particular, contracts involving international parties via the Internet require delving into private international law, the determination of the judicial area for the resolution of electronic commerce disputes and the determination of applicable law was a major burden on parties and States, which prompted their clients to seek alternative electronic mechanisms to replace traditional courts to settle disputes resulting from the use of electronic media in their commercial transactions, so-called ODR dispute resolution. s electronic teleconference, this has made recourse to electronic or digital arbitration as a virtual judge system a requirement of many international organizations and associations. The forms raised: how effective is digital or electronic arbitration in resolving e-commerce disputes? We therefore divide our research into two sections, dealing with section I: the conceptual framework for electronic commerce as well as digital electronic arbitration, and section II: the role of digital arbitration in the termination and resolution of e-commerce disputes.

Pharmaceutical Inspection Co-operation Scheme: An Overview.

To address the challenges posed by the globalization of regulatory agencies, it is essential to harmonize regulatory requirements, assess Good Manufacturing Practice (GMP) compliance, license production facilities, manage product recalls, and improve information exchange. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) provides a robust framework for tackling these global issues. Through the PIC/S GMP Forum, PIC/S facilitates informal interactions among non-member authorities, professionals, and various organizations with the Committee, fostering networking and collaboration. Furthermore, PIC/S has developed a comprehensive guide on GMP requirements for inspectorates and organizations, ensuring consistent standards across borders. The scheme collaborates with other organizations to enhance and complement collective efforts. With 56 countries involved in PIC/S, whether as members or through the Accession and Pre-Accession Process, the exchange of inspection reports among authorities verifies compliance with PIC/S standards, leading to fewer and more targeted inspections and reducing redundancy. This study's purpose is to establish uniform GMP standards by providing extensive training for inspectors and promoting collaboration and networking among regional and international bodies, regulatory authorities, and other relevant organizations. This approach seeks to build trust in inspections, optimize resource use, and foster a more efficient regulatory environment. Through these efforts, PIC/S continues to play a pivotal role in advancing global pharmaceutical regulatory practices.

Barriers and framework conditions for the market entry of second-life lithium-ion batteries from electric vehicles

Transition to circular economy for lithium-ion batteries used in electric vehicles requires integrating multiple stages of the value cycle. However, strategies aimed at extending the lifetime of batteries are not yet sufficiently considered within the European battery industry, particularly regarding repurposing. Using second-life lithium-ion batteries (SLBs) before subsequent recycling can offer several advantages, such as the development of sustainable business models, the reduction of emissions, and alignment with UN Sustainable Development Goals 7, 12, and 13. Using expert and problem-centred interviews along with an exploratory workshop, this study guides stakeholders in the battery sector by illustrating the necessary changes for a more holistic circular economy. Moreover, an extended political, economic, social, technological, environmental, legal, and additionally safety-related (PESSTEL) analysis approach is carried out, which has not yet been used in this context. In this process, barriers, as well as necessary institutional framework conditions and organisational requirements for a successful market entry of SLB applications are investigated. Among others, key barriers relate to the competition with first-life applications and safety concerns. SLBs require high manual labour costs for repurposing, along with expenses for expired warranties and re-certifications. Ownership structures in traditional business models often result in SLBs and their corresponding usage data staying under the control of the manufacturers. Market viability, however, requires a level playing field for both first-life and second-life operators as well as circular battery and data-sharing business models. Gathering data on the ageing performance and performing improved safety testing according to test protocols facilitates the reliable assessment of SLBs.

Factors Promoting a Sense of Home Among Older Adults in Residential Care Facilities in Italy.

Understanding the housing needs of older adults is crucial for policy makers, service providers, and professional carers. Evidence about the factors that contribute to older adults' "sense of home" and their practical and policies implications are lacking. Semi-structured interviews were conducted with 78 community-dwelling older adults to investigate which structural and organizational requirements and relational-affective environments could contribute to their experiencing a sense of home. Through inductive content analysis 119 subcategories were derived and grouped into eight main categories: being considered as a person; a safe, quiet, welcoming, and personalizable environment; meaningful relationships; optional and stimulating activities; active involvement in the organization within the facility; competent care personnel; preserving life memories; facility open and integrated with the community. Findings suggest that multiple factors might influence "feeling at home," and many strategies can be adopted to facilitate older adults' successful adaptation. It is important that healthcare organizations consider these factors from a person-centered care perspective, and that care staff are trained in this type of care to enhance staff decision-making and older adults' wellbeing.

Geospatial Point-of-Care Testing Strategies for COVID-19 Resilience in Resource-Poor Settings: Rural Cambodia Field Study.

Point-of-care testing (POCT) generates intrinsically fast, inherently spatial, and immediately actionable results. Lessons learned in rural Cambodia and California create a framework for planning and mobilizing POCT with telehealth interventions. Timely diagnosis can help communities assess the spread of highly infectious diseases, mitigate outbreaks, and manage risks. The aims of this study were to identify the need for POCT in Cambodian border provinces during peak COVID-19 outbreaks and to quantify geospatial gaps in access to diagnostics during community lockdowns. Data sources comprised focus groups, interactive learners, webinar participants, online contacts, academic experts, public health experts, and officials who determined diagnostic needs and priorities in rural Cambodia during peak COVID-19 outbreaks. We analyzed geographic distances and transit times to testing in border provinces and assessed a high-risk province, Banteay Meanchey, where people crossed borders daily leading to disease spread. We strategized access to rapid antigen testing and molecular diagnostics in the aforementioned province and applied mobile-testing experience among the impacted population. COVID-19 outbreaks were difficult to manage in rural and isolated areas where diagnostics were insufficient to meet needs. The median transit time from border provinces (n=17) to testing sites was 73 (range 1-494) minutes, and in the high-risk Banteay Meanchey Province (n=9 districts), this transit time was 90 (range 10-150) minutes. Within border provinces, maximum versus minimum distances and access times for testing differed significantly (P<.001). Pareto plots revealed geospatial gaps in access to testing for people who are not centrally located. At the time of epidemic peaks in Southeast Asia, mathematical analyses showed that only one available rapid antigen test met the World Health Organization requirement of sensitivity >80%. We observed that in rural Solano and Yolo counties, California, vending machines and public libraries dispensing free COVID-19 test kits 24-7 improved public access to diagnostics. Mobile-testing vans equipped with COVID-19 antigen, reverse transcription polymerase chain reaction, and multiplex influenza A/B testing proved useful for differential diagnosis, public awareness, travel certifications, and telehealth treatment. Rural diagnostic portals implemented in California demonstrated a feasible public health strategy for Cambodia. Automated dispensers and mobile POCT can respond to COVID-19 case surges and enhance preparedness. Point-of-need planning can enhance resilience and assure spatial justice. Public health assets should include higher-quality, lower-cost, readily accessible, and user-friendly POCT, such as self-testing for diagnosis, home molecular tests, distributed border detection for surveillance, and mobile diagnostics vans for quick telehealth treatment. High-risk settings will benefit from the synthesis of geospatially optimized POCT, automated 24-7 test access, and timely diagnosis of asymptomatic and symptomatic patients at points of need now, during new outbreaks, and in future pandemics.

Political burden of local government and land insider trading in major Chinese cities

ABSTRACT Chinese local governments transfer political burdens through land trading. One key example of this practice is the requirement for for-profit organizations to bid on land when undertaking public welfare projects. By analysing comprehensive data on public welfare project development in major Chinese cities, we conducted regression analyses and endogeneity tests to explore whether there is a causal relationship between the political burdens faced by for-profit organizations and their land trading priorities, with a focus on insider trading characteristics. Our findings reveal that, even in marketized transactions, the land designated for public welfare projects tends to have lower prices and bidding premiums, reflecting key insider trading traits. Price priority is more apparent among private developers, indicating higher compensation for political burdens, while premium priority is more evident among government-controlled enterprises due to increased paternalism.

Cost-Effective Scalability in Cloud Monitoring Systems: A Comparative Stud

This research article explores strategies for cost-effective scalability in cloud monitoring systems. As the complexity and scale of IT-based infrastructure are growing, an efficient monitoring system becomes vital for maintaining performance and optimizing resources while managing costs. The current study aims to shed light on various approaches to cost-effective scalability by considering factors such as data collection methods, storage optimization, and adaptive monitoring techniques. A comparison between cloud monitoring tools, Amazon Cloud Watch and Datadog, has been made to gain a better understanding of the monitoring tools. The research indicates that a multi-faceted approach is necessary for cost-effective scalability in cloud monitoring systems, and there must be a holistic approach in the selection of cloud monitoring tools, depending on the organization's requirements. In the later sections, strategies, like distributed data collection, hierarchical aggregation, adaptive sampling, and machine learning- based predictive scaling, can significantly improve monitoring system scalability while optimizing resource utilization.

Developing Organizational Requirements to Standardize Delivery and Improve Quality of Acute Leukemia Care in Ontario.

Acute leukemia is a rapidly progressive cancer of the blood and bone marrow that requires a high degree of complex, specialized, resource-intensive clinical and supportive care. The aging Canadian population has introduced an unprecedented demand on the health care system for a variety of illnesses, including acute leukemia. The purpose of this work was to develop organizational requirements for service providers delivering care for patients aged 18 years and older with acute leukemia within a single-payer health care system in Ontario. This initiative was intended to support streamlining high-quality health care across Ontario. We worked collaboratively with an expert panel to conduct a review of the literature to synthesize the organizational requirements for delivering acute leukemia care. A total of 229 requirements were developed. The requirements were categorized into themes including (1) facility requirements, including infrastructure, data management, safety, policies and procedures; (2) availability of clinical services and service complexity; (3) personnel, including roles, responsibilities, and ongoing education; (4) patient care; (5) quality management; (6) clinical research; and (7) laboratory services. These requirements will act as a framework for the provision of service, complexity of care, safety, accessibility, and quality care across all levels from the patient, organization, and system perspectives. This framework will help support person-centred care, emphasizing providing care close to home, while optimizing the use of specialized resources. Moving forward, Ontario Health (Cancer Care Ontario) will continue to work with acute leukemia service providers in the province to determine compliance and focus improvement efforts in priority areas.

Historical structuring and technological evolution of the national geodetic network of Chile - horizontal

The Military Geographic Institute (IGM) wasset up in accordance with the Decree Law N°1.664 of the 29th of August, 1922 and is currently the official technical and permanent service of the State, in all geographic matters, in compliance with the second point of Article N.° 2 of Law N.° 15284 of 1963. Among the most important of its tasks is the mission of providing a Reference Frame in accordance with the requirements of the international standards of each epoch, for the production of geo-referenced information. The National Geodesic Network (RGN in Spanish initials) has been thereference framefor all geodesic and cartographic activities and portrayals over time. It is made up of geodesic points set up at strategic locations across and along this territory, measured and calculated by this Institute; these have plane, geographic and altitude coordinate values. Currently, the horizontal component of the SIRGAS-Chile RGN consists of a set of Continuous Operation Reference Stations (CORS), providing daily GNSS data and official coordinates for the various uses of national development.Chile, due to its special geographic situation, arising from its location and its long, narrow, and elongated territory has had to adopt, over time, various geodesic reference systems in accordance with the requirements of international organisations that support and promote geodesy. Moreover, since 1922, these reference systems have evolved due to substantial progress in technology, defining a RGN that is modern and precise at this time.

A comprehensive review of the characterization, host interactions, and stabilization advancements on probiotics: Addressing the challenges in functional food diversification.

The demand for functional food is rising in tandem with the prevalence of chronic diseases. Probiotics play a crucial role in functional food development, yet their ability to confer health benefits to the host remains a topic of debate according to Food and Agriculture Organization/World Health Organization requirements. The application of culturomics, innovative isolation techniques, within the realm of probiotics is increasingly deemed essential for fully harnessing the latent potential of microbial reservoirs. Nevertheless, its application remains confined predominantly to human fecal sources. Following the integration of probiogenomics, significant advancements have been made in the safety assessment of probiotics. However, the adoption of novel probiotic microorganisms has yet to match the requisite pace. Progress in research concerning host-probiotic interactions by employing omics technologies, particularly in animal models, is notable. Nonetheless, the comprehensive elucidation of mechanisms of action and human trial studies are lagging behind. Additionally, the viability of probiotics, spanning from their production as functional foods to their transit to the human colon, has markedly improved through encapsulation techniques. Nevertheless, opportunities for exploration persist regarding alternative coating materials and diverse encapsulation methodologies. Furthermore, there is a discernible transition in the domain of probiotic-based functional foods, shifting away from a primarily dairy-centric focus toward inclusion in a broader array of food categories. This comprehensive review addresses critical issues ranging from isolation sources and novel techniques to the final functional food developments. while doing so, it explores probiogenomics applications for probiotic characterization, investigations into host-probiotic interactions, and strategies for probiotic stabilization under harsh environmental conditions.