A sustainable approach towards extraction of diosgenin from fenugreek seeds using polystyrene/divinyl benzene resin.

Diosgenin, a bioactive molecule; is one of the deeply explored saponin with a wide spectrum of benefits against various ailments. The extraction and yield enhancement of diosgenin from a wide range of naturally occurring medicinal products has always been a challenging task for its commercial usage. The current research work envisages the use of a novel resin to maximize the yield of diosgenin. The extracted diosgenin was characterized using modern techniques. The current method qualifies for the extraction of diosgenin at a large scale making it a commercially viable technique.

Global regulatory policies for animal biotechnology: overview, opportunities and challenges.

Genome editing (GnEd) has the potential to provide many benefits to animal agriculture, offering a means for achieving rapid growth, disease resistance, and novel phenotypes. The technology has the potential to be useful for rapidly incorporating traits into existing selectively bred animals without the need for crossbreeding and backcrossing. Yet only four products from animals created via biotechnology, all growth-enhanced fishes, have reached commercialization and only on a limited scale. The past failure of genetically engineered (or GM) products to reach conventional producers can largely be attributed to the high cost of meeting GMO regulatory requirements. We review the history of GMO regulations internationally, noting the influence of Codex Alimentarius on the development of many existing regulatory frameworks. We highlight new regulatory approaches for GnEd organisms, first developed by Argentina, and the adoption of similar approaches by other countries. Such new regulatory approaches allow GnEd organisms that could have been developed by conventional means to be regulated under the same rules as conventional organisms and in the future is likely to enhance the opportunity for biotech animals to enter production. Treating certain GnEd products as conventional has had a large impact on the variety of biotechnological innovations successfully navigating regulatory processes. We suggest that for the full potential of GnEd technologies to be realized, enabling public policies are needed to facilitate use of GnEd as a breeding tool to incorporate new traits within existing animal breeding programs, rather than only a tool to create distinct new products.

Implementation and Preliminary Evaluation of an Entrepreneurship, Biomedical Innovation, and Design Pathway in a School of Medicine Curriculum.

Background: New educational curricula are emerging to train physicians to practice healthcare in the 21st century. The University of Massachusetts Chan Medical School T.H. Chan School of Medicine (UMass Chan) implemented an MD curriculum redesign in the fall of 2022 that included seven educational pathways, including Entrepreneurship, Biomedical Innovation and Design. This pathway is modeled after the I-Corps curriculum with added material regarding engineering design. This manuscript describes this pathway curriculum and provides preliminary evaluation data and learning outcomes. Methods: First-year (Class of 2027) and second-year (Class of 2026) pathway students were invited to participate in online surveys evaluating course material and their knowledge of course content. Course evaluations and self-assessments were performed on a 4 or 5 point Likert scale. The material assessment comprised of multiple-choice questions; some had four options while others had five. Simple means were calculated for each question of the self-assessment, and as an aggregate. A two-sample t-test was performed using those means to assess statistical significance. A distribution of correct and incorrect answers was generated between the pre and post survey results, and a chi-squared analysis was used to determine whether the two correct/incorrect distributions were significantly different. Results: Initial results show that the program was well received, with 15/20 (75%) of first year students rating the experience as good or excellent and 8/10 (80%) of second year students rating the experience as good or excellent. Three lectures were provided during the Fall 2023 semester to 11 second-year students. Results of self-assessment of student comfort and understanding of engineering content significantly improved after delivery of these lectures. Objective student knowledge also significantly improved. Conclusions: This new pathway curriculum at UMass Chan is designed to introduce students to the principles of innovation, entrepreneurship, and technology commercialization. An element of this pathway focused on basic engineering principles provided students with baseline understandings of biomedical design, human factors, and risk/hazard analysis. Despite small sample sizes, the results show improvements in student comfort with the material and knowledge. Novel curricula have the potential to transform medical education and prepare future physicians to practice healthcare in the 21st Century.

The Liquid Metal Age: A Transition From Hg to Ga.

This review offers an illuminating journey through the historical evolution and modern-day applications of liquid metals, presenting a comprehensive view of their significance in diverse fields. Tracing the trajectory from mercury applications to contemporary innovations, the paper explores their pivotal role in industry and research. The analysis spans electrical switches, mechanical applications, electrodes, chemical synthesis, energy storage, thermal transport, electronics, and biomedicine. Each section examines the intricacies of liquid metal integration, elucidating their contributions to technological advancements and societal progress. Moreover, the review critically appraises the challenges and prospects inherent in liquid metal applications, addressing issues of recycling, corrosion management, device stability, economic feasibility, translational hurdles, and market dynamics. By delving into these complexities, the paper advances scholarly understanding and offers actionable insights for researchers, engineers, and policymakers. It aims to catalyze innovation, foster interdisciplinary collaboration, and promote liquid metal-enabled solutions for societal needs. Through its comprehensive analysis and forward-looking perspective, this review serves as a guide for navigating the landscape of liquid metal applications, bridging historical legacies with contemporary challenges, and highlighting the transformative potential of liquid metals in shaping future technologies.

Ação Direta de Inconstitucionalidade nº 5.779: a preponderância da efetividade do direito à saúde sobre a hierarquia das normas jurídicas / Direct Action of Unconstitutionality No. 5.779: the preponderance of the effectiveness of the right to health over the hierarchy of legal norms / Acción Directa de Inconstitucionalidad nº 5.779: la preponderancia de la efectividad del derecho a la salud sobre la jerarquía de las normas jurídicas

Objetivo: refletir se a hierarquia das normas jurídicas deve ser usada como método de solução infalível mesmo quando um conflito aparente entre normas jurídicas que envolva o direito à saúde e, sobretudo, a sua efetividade, puder ser melhor resolvido mediante decisão técnica do órgão regulador competente. Metodologia: estudo descritivo de abordagem qualitativa e análise documental. Foram analisadas as Resolução de Diretoria Colegiada nº 52/2011, Lei nº 13.454/2017 e Ação Direta de Inconstitucionalidade nº 5.779-DF. Buscou-se doutrina jurídica especializada sobre os temas central e periféricos. Para análise dos dados utilizou-se a técnica da revisão crítico-narrativa. Resultados: no Brasil, a adoção das agências reguladoras como agente normativo e regulador de atividades econômicas viabilizou a tomada de decisões pautadas menos em critérios políticos que em critérios técnicos. O legislador, ancorado em critérios políticos, segundo o entendimento do Judiciário, não pode ultrapassar os critérios técnicos. Conclusão: do julgamento da Ação Direta de Inconstitucionalidade nº 5.779 se extrai que o conceito hodierno e a natureza jurídica do direito à saúde impõem novos paradigmas jurídicos que validam o papel das agências reguladoras (tomada de decisões técnicas em prol da máxima efetividade do direito à saúde), ainda que em detrimento de decisões do legislador, legitimadas politicamente. O paradigma formal não pode obstar a materialização do direito.

Objective: To reflect on whether the hierarchy of legal norms should be used as an infallible method of solution even when an apparent conflict between legal norms involving health law can be better resolved through a technical decision by the competent regulatory agency. Methodology: data was collected. In particular, Resolução de Diretoria Colegiada nº 52/2011, Law nº 13.454/2017 and Ação Direta de Inconstitucionalidade nº 5.779-DF. Specialized legal doctrine was sought on the central and peripheral themes. The data collected was analyzed using the critical-narrative review technique. Results: In Brazil, the adoption of regulatory agencies as normative agents and regulators of economic activities has made it possible to make decisions based less on political criteria than on technical criteria. The legislator, anchored in political criteria, according to the judiciary, cannot go beyond technical criteria. Conclusion: the judgment in Ação Direta de Inconstitucionalidade nº 5.779 shows that today's concept and the legal nature of the right to health impose new legal paradigms that validate the role of regulatory agencies (making technical decisions in favor of maximum effectiveness of the right to health), even to the detriment of politically legitimized decisions by the legislature. The formal paradigm cannot prevent the materialization of the right.

Objetivo: reflexionar si la jerarquía de las normas jurídicas debe utilizarse como método infalible de solución, incluso cuando un conflicto aparente entre normas jurídicas que impliquen al Derecho sanitario pueda resolverse mejor mediante una decisión técnica del órgano regulador competente. Metodología: se recopilaron datos. En particular, RDC nº 52/2011, Ley nº 13.454/2017 y ADI nº 5.779-DF. Se buscó doctrina jurídica especializada sobre los temas centrales y periféricos. Los datos recogidos se analizaron mediante la técnica de revisión crítico-narrativa. Resultados: En Brasil, la adopción de las agencias reguladoras como agentes normativos y reguladores de las actividades económicas ha permitido tomar decisiones basadas menos en criterios políticos que en criterios técnicos. El legislador, anclado en criterios políticos, según el poder judicial, no puede ir más allá de los criterios técnicos. Conclusión: la sentencia en el asunto ADI 5.779 demuestra que el concepto actual y la naturaleza jurídica del derecho a la salud imponen nuevos paradigmas jurídicos que validan el papel de las agencias reguladoras (que adoptan decisiones técnicas en favor de la máxima efectividad del derecho a la salud), incluso en detrimento de las decisiones políticamente legitimadas del poder legislativo. El paradigma formal no puede impedir la materialización del derecho.

Barriers to commercial deployment of biorefineries: A multi-faceted review of obstacles across the innovation chain.

Realizing integrated biorefineries producing multiple fuels, chemicals and materials from sustainable biomass feedstocks holds promise for transitioning industries onto low-carbon trajectories. However, widespread commercial implementation remains elusive despite two decades of technological advancements. This review synthesizes current literature to provide a comprehensive analysis of key multi-dimensional barriers inhibiting the scale-up of biorefineries. The review discusses the technical challenges around biomass conversion processes. Economic viability concerns such as high capital costs and lack of market competitiveness are also assessed. The review also evaluates the regulatory and policy complexities that poses risks and uncertainties in the scaling up of biorefineries. Socio-political acceptance hurdles including community engagement and public perception are also reviewed. The interconnected nature of these challenges is emphasized and strategies are recommended to enable full potential realization, covering areas such as enhanced stakeholder collaboration, advanced process intensification, supportive policy frameworks, innovative financing models and strategic marketing initiatives. International pilots and cross-sectoral knowledge exchange are highlighted as priority enablers. In conclusion, this review synthesizes insights from extensive demonstration efforts to identify priorities and pathways for accelerating the global commercial transition towards sustainable biorefinery implementation. It aims to inform strategic decision-making and collaborative actions amongst stakeholders in research, industry and policy domains.

Genome-Editing Products Line up for the Market: Will Europe Harvest the Benefits from Science and Innovation?

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) technologies have revolutionized genome editing, significantly advancing the improvement of cultivated crop species. This review provides an overview of genome-edited crops that have either reached the market or received the necessary approvals but are not yet available to consumers. We analyze various genome-editing studies to understand the distribution of different genome-editing systems, the types of site-directed nucleases employed, and the geographical spread of these studies, with a specific focus on global and European contexts. Additionally, we examine the target crops involved. The review also outlines the multiple steps required for the legal acceptance of genome-edited crops within European jurisdictions. We conclude with suggestions for the future prospects of genome-editing research in Europe, aiming to streamline the approval process and enhance the development and adoption of genome-edited crops.

American Society of Retina Specialists Artificial Intelligence Task Force Report.

Since the Artificial Intelligence Committee of the American Society of Retina Specialists developed the initial task force report in 2020, the artificial intelligence (AI) field has seen further adoption of US Food and Drug Administration-approved AI platforms and significant development of AI for various retinal conditions. With expansion of this technology comes further areas of challenges, including the data sources used in AI, the democracy of AI, commercialization, bias, and the need for provider education on the technology of AI. The overall focus of this committee report is to explore these recent issues as they relate to the continued development of AI and its integration into ophthalmology and retinal practice.

Challenges and opportunities in commercializing whole-cell bioreporters in environmental application.

Since the initial introduction of whole-cell bioreporters (WCBs) nearly 30 years ago, their high sensitivity, selectivity, and suitability for on-site detection have rendered them highly promising for environmental monitoring, medical diagnosis, food safety, biomanufacturing, and other fields. Especially in the environmental field, the technology provides a fast and efficient way to assess the bioavailability of pollutants in the environment. Despite these advantages, the technology has not been commercialized. This lack of commercialization is confusing, given the broad application prospects of WCBs. Over the years, numerous research papers have focused primarily on enhancing the sensitivity and selectivity of WCBs, with little attention paid to their wider commercial applications. So far, there is no a critical review has been published yet on this topic. Therefore, in this article we critically reviewed the research progress of WCBs over the past three decades, assessing the performance and limitations of current systems to understand the barriers to commercial deployment. By identifying these obstacles, this article provided researchers and industry stakeholders with deeper insights into the challenges hindering market entry and inspire further research toward overcoming these barriers, thereby facilitating the commercialization of WCBs as a promising technology for environmental monitoring.

Commercialization of the Xalkori Pediatric Multiparticulate Product Using Quality-by-Design Principles.

A pediatric dosage form for crizotinib (Xalkori) was commercialized using quality-by-design principles in a material-sparing fashion. The dosage form consists of spherical multiparticulates (microspheres or pellets) that are coated and encapsulated in capsules for opening. The crizotinib (Xalkori)-coated pellet product is approved in the US for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) and unresectable, recurrent, or refractory inflammatory myofibroblastic tumor (IMT) that is ALK-positive. The product is also approved in the US for adult patients with non-small cell lung cancer (NSCLC) who are unable to swallow intact capsules. The lipid multiparticulate is composed of a lipid matrix, a dissolution enhancer, and an active pharmaceutical ingredient (API). The API, which remains crystalline, is embedded within the microsphere at a 60% drug loading in the uncoated lipid multiparticulate to enable dose flexibility. The melt spray congealing technique using a rotary atomizer is used to manufacture the lipid multiparticulate. Following melt spray congealing, a barrier coating is applied via fluid bed coating. Due to their particle size and content uniformity, this dosage form provides the dosing flexibility and swallowability needed for the pediatric population. The required pediatric dose is achieved by opening the capsules and combining doses of different encapsulated dose strengths, followed by administration of the multiparticulates directly to the mouth. The encapsulation process was optimized through equipment modifications and by using a design of experiments approach to understand the operating space. A limited number of development batches produced using commercial-scale equipment were leveraged to design, understand, and verify the manufacturing process space. The quality by design and material-sparing approach taken to design the melt spray congeal and encapsulation manufacturing processes resulted in a pediatric product with exceptional content uniformity (a 95% confidence and 99% probability of passing USP <905> content uniformity testing for future batches).

Fusing Science with Industry: Perovskite Photovoltaics Moving Rapidly into Industrialization.

The organic-inorganic lead halide per materials have emerged as highly promising contenders in the field of photovoltaic technology, offering exceptional efficiency and cost-effectiveness. The commercialization of perovskite photovoltaics hinges on successfully transitioning from lab-scale perovskite solar cells to large-scale perovskite solar modules (PSMs). However, the efficiency of PSMs significantly diminishes with increasing device area, impeding commercial viability. Central to achieving high-efficiency PSMs is fabricating uniform functional films and optimizing interfaces to minimize energy loss. This review sheds light on the path toward large-scale PSMs, emphasizing the pivotal role of integrating cutting-edge scientific research with industrial technology. By exploring scalable deposition techniques and optimization strategies, the advancements and challenges in fabricating large-area perovskite films are revealed. Subsequently, the architecture and contact materials of PSMs are delved while addressing pertinent interface issues. Crucially, efficiency loss during scale-up and stability risks encountered by PSMs is analyzed. Furthermore, the advancements in industrial efforts toward perovskite commercialization are highlighted, emphasizing the perspective of PSMs in revolutionizing renewable energy. By highlighting the scientific and technical challenges in developing PSMs, the importance of combining science and industry to drive their industrialization and pave the way for future advancements is stressed.

Integrated Benefits to Agriculture with Trichoderma and Other Endophytic or Root-Associated Microbes.

The use of endophytic microbes is increasing in commercial agriculture. This review will begin with a strain selection. Most strains will not function well, so only a few provide adequate performance. It will also describe the endophyte-plant relationship and the fungi and bacteria involved. Their abilities to alleviate biotic (diseases and pests) and abiotic stresses (drought, salt, and flooding) to remediate pollution and increase photosynthetic capabilities will be described. Their mechanisms of action will be elucidated. These frequently result in increased plant yields. Finally, methods and practices for formulation and commercial use will be described.

Key challenges in the advancement and industrialization of biobased and biodegradable plastics: a value chain overarching perspective.

At the International Symposium on Biodegradable Polymers (ISBP2022) in Sion, Switzerland, experts from academia and industry underscored the remarkable progress in biobased and biodegradable polymers (BBPs) since their initial commercialization around 50 years ago. Despite significant advancements, the technology readiness level (TRL), market adoption, and industrialization of BBPs is not yet competitive to conventional plastics. In this perspective, we summarize the challenges and requirements for advancing the development and industrialization of BBPs, drawing insights from international experts coming from academia and industry, who had participated in the survey and podium discussion during the ISBP2022. In fact, BBPs grapple with persistent and emerging challenges throughout the value chain. These challenges can be grouped into four areas and involve i) the pursuit of sustainable feedstocks together with efficient production and downstream processes as well as recycling technologies and infrastructure; ii) meeting or revisiting product requirements by industry, markets, and consumers; iii) navigating a non-level playing field in their sustainability assessment (LCA) compared to conventional plastics; and iv) struggling with underdeveloped and partially biased policy and financial frameworks as well as lacking clear definitions, terminologies and communication.

Highly Efficient Multicolor-Emitting Tetraphenylethylene-Based Organic Salts with Commercialization Prospects.

Since the discovery of aggregation-induced emission from tetraphenylethylene derivatives, various methods have been explored to prepare highly efficient multicolored luminescent materials. Herein, we report a simple and efficient strategy for constructing luminescent organic salts of the tetracationic luminogen, tetrapyridinium-tetraphenylethylene (T4Py-TPE4+), combined with seven di- and tetra-anionic aromatic sulfonate ligands. When aqueous solutions of the cationic luminogen and the anionic ligands were mixed, they rapidly aggregated into organic salts within seconds to minutes, giving yields of up to >90%. This was accompanied by an increase in the emission efficiency from ∼58% to almost 100%, and the ability to tune the emission color between 511 and 586 nm. These improvements were mainly attributed to the strong electrostatic attractions between the cation and anions, which resulted in the formation of a rigid hydrophobic network of the T4Py-TPE4+ luminogen with various π-conjugation lengths. Because these compounds are commercially available, this method opens the possibility of fabricating novel light-emitting materials for device fabrication and research.

Addressing the consequences of the corporatization of reproductive medicine.

In Australia and the UK, commercialization and corporatization of assisted reproductive technologies have created a marketplace of clinics, products, and services. While this has arguably increased choice for patients, 'choice', shaped by commercial imperatives may not mean better-quality care. At present, regulation of clinics (including clinic-corporations) and clinicians focuses on the doctor-patient dyad and the clinic-consumer dyad. Scant attention has been paid to the conflicts between the clinic-corporation's duty to its shareholders and investors, the medical profession's duty to the corporations within which they practice, and the obligations of both clinicians and corporations to patients and to health systems. Frameworks of regulation based in corporate governance and business ethics, such as stakeholder models and 'corporate social responsibility', have well-recognized limits and may not translate well into healthcare settings. This means that existing governance frameworks may not meet the needs of patients or health systems. We argue for the development of novel regulatory approaches that more explicitly characterize the obligations that both corporations and clinicians in corporate environments have to patients and to society, and that promote fulfilment of these obligations. We consider mechanisms for application in the multi-jurisdictional setting of Australia, and the single jurisdictional settings of the UK.

Toward the scale-up production of polymeric nanotherapeutics for cancer clinical trials.

Nanotherapeutics have gained significant attention for the treatment of numerous cancers, primarily because they can accumulate in and/or selectively target tumors leading to improved pharmacodynamics of encapsulated drugs. The flexibility to engineer the nanotherapeutic characteristics including size, morphology, drug release profiles, and surface properties make nanotherapeutics a unique platform for cancer drug formulation. Polymeric nanotherapeutics including micelles and dendrimers represent a large number of formulation strategies developed over the last decade. However, compared to liposomes and lipid-based nanotherapeutics, polymeric nanotherapeutics have had limited clinical translation from the laboratory. One of the key limitations of polymeric nanotherapeutics formulations for clinical translation has been the reproducibility in preparing consistent and homogeneous large-scale batches. In this review, we describe polymeric nanotherapeutics and discuss the most common laboratory and scale-up formulation methods, specifically those proposed for clinical cancer therapies. We also provide an overview of the major challenges and opportunities for scaling polymeric nanotherapeutics to clinical-grade formulations. Finally, we will review the regulatory requirements and challenges in advancing nanotherapeutics to the clinic.

Conceptualizing the Commercialization of Human Milk: A Concept Analysis.

BACKGROUND: Donor human milk is recommended when infants are unable to be fed their mother's own milk or require supplementation. For-profit companies use technologies to create human milk products for infants in the neonatal intensive care setting without consistent guidelines and regulatory frameworks in place. This commercialization of human milk is inadequately conceptualized and ill-defined. RESEARCH AIMS: The aim of this study is to conceptualize and define the commercialization of human milk and discuss the need for policy guidelines and regulations. METHOD: Using a concept analysis framework, we reviewed the literature on the commercialization of human milk, analyzed the antecedents and potential consequences of the industry, and developed a conceptual definition. The literature review resulted in 13 relevant articles. RESULTS: There has been a surge in the development and availability of human milk products for vulnerable infants developed by for-profit companies. Commercialized human milk can be defined as the packaging and sale of human milk and human milk components for financial gain. Factors contributing to the commercialization of human milk include an increased demand for human milk, and consequences include potential undermining of breastfeeding. The lack of guidelines and regulations raises concerns of equity, ethics, and safety. CONCLUSION: The industry is rapidly growing, resulting in an urgent need for consistent guidelines and regulatory frameworks. If left unaddressed, there could be potential risks for donor milk banking, the future of breastfeeding, and infant and maternal health.

Recent progress in electro-Fenton technology for the remediation of pharmaceutical compounds in aqueous environments.

The global focus on wastewater treatment has intensified in the contemporary era due to its significant environmental and human health impacts. Pharmaceutical compounds (PCs) have become an emerging concern among various pollutants, as they resist conventional treatment methods and pose a severe environmental threat. Advanced oxidation processes (AOPs) emerge as a potent and environmentally benign approach for treating recalcitrant pharmaceuticals. To address the shortcomings of traditional treatment methods, a technology known as the electro-Fenton (EF) method has been developed more recently as an electrochemical advanced oxidation process (EAOP) that connects electrochemistry to the chemical Fenton process. It has shown effective in treating a variety of pharmaceutically active compounds and actual wastewaters. By producing H2O2 in situ through a two-electron reduction of dissolved O2 on an appropriate cathode, the EF process maximizes the benefits of electrochemistry. Herein, we have critically reviewed the application of the EF process, encompassing diverse reactor types and configurations, the underlying mechanisms involved in the degradation of pharmaceuticals and other emerging contaminants (ECs), and the impact of electrode materials on the process. The review also addresses the factors influencing the efficiency of the EF process, such as (i) pH, (ii) current density, (iii) H2O2 concentration, (iv) and others, while providing insight into the scalability potential of EF technology and its commercialization on a global scale. The review delves into future perspectives and implications concerning the ongoing challenges encountered in the operation of the electro-Fenton process for the treatment of PCs and other ECs.