Techno-functional properties of dry-fractionated plant-based proteins and application in food product development: a review.

Dry-fractionated protein concentrates are gaining attention because they are produced using a versatile and sustainable technology, which can be applied to a wide range of plant material. To facilitate their utilization in new product development, it is crucial to obtain a comprehensive overview of their techno-functional properties. The present review aims to examine the techno-functional properties of dry-fractionated protein concentrates and describe their primary applications in food products, considering the published works in the last decade. The techno-functional properties of proteins, including water absorption capacity, emulsifying and foaming properties, gelling ability or protein solubility, are relevant factors to consider during food formulation. However, these properties are significantly influenced by the extraction technology, the type of protein and its characteristics. Overall, dry-fractionated proteins are characterized by high protein solubility, high foaming ability and foam stability, and high gelling ability. Such properties have been exploited in the development of food, such as bakery products and pasta, with the aim of increasing the protein content and enhancing the nutritional value. Additionally, innovative foods with distinctive textural and nutritional characteristics, such as meat and dairy analogues, have been developed by using dry-fractionated proteins. The results indicate that the study of these ingredients still needs to be improved, including their application with a broader range of plant materials. Nevertheless, this review could represent an initial step to obtaining an overview of the techno-functional properties of dry-fractionated proteins, facilitating their use in foods. © 2023 The Authors. Journal of The Science of Food and Agriculture published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

Consumption of edible insects and insect-based foods: A systematic review of sensory properties and evoked emotional response.

Low consumer acceptance of edible insects and insect-based products is one of the main barriers to the successful implementation of entomophagy in Western countries. This rejection is mainly caused by consumers' negative emotional responses, psychological/personality traits, and attitudes toward food choices. However, as the role of intrinsic product characteristics on such food choices has not been adequately studied, a systematic review was conducted following the PRISMA method, to analyze studies that have assessed hedonic evaluations, sensory profiling, or emotional responses to edible insects or insect-based products. The majority of studies performed with whole insects and insect flour highlight that insect-based products are more negatively evaluated than control products. Although the sensory properties of insects are affected by species and processing conditions, they are generally negative across sensory dimensions. In particular, insects and insect-based products are generally associated with odor and flavor/taste attributes that are related to old/spoiled food. These negative attributes can be linked to the fat fraction of edible insects, with insect oils being very negatively evaluated by consumers. On the other hand, defatted fractions and deodorized oils are not associated with these negative attributes, further supporting the hypothesis that the fat fraction is responsible for the negative odor and flavor/taste attributes. However, there is still a lack of studies assessing the sensory profile of edible insects and insect-based products, as well as consumers' emotional responses to their consumption. Future studies should focus on the effects of different processing conditions, products incorporating insect fractions (namely protein concentrates/isolates and defatted fractions), and evaluation by target consumer groups.

Current State and Opportunities with Long-acting Injectables: Industry Perspectives from the Innovation and Quality Consortium "Long-Acting Injectables" Working Group.

Long-acting injectable (LAI) formulations can provide several advantages over the more traditional oral formulation as drug product opportunities. LAI formulations can achieve sustained drug release for extended periods of time, which results in less frequent dosing requirements leading to higher patient adherence and more optimal therapeutic outcomes. This review article will provide an industry perspective on the development and associated challenges of long-acting injectable formulations. The LAIs described herein include polymer-based formulations, oil-based formulations, and crystalline drug suspensions. The review discusses manufacturing processes, including quality controls, considerations of the Active Pharmaceutical Ingredient (API), biopharmaceutical properties and clinical requirements pertaining to LAI technology selection, and characterization of LAIs through in vitro, in vivo and in silico approaches. Lastly, the article includes a discussion around the current lack of suitable compendial and biorelevant in vitro models for the evaluation of LAIs and its subsequent impact on LAI product development and approval.

Frameworks for Health Technology Assessment at an Early Stage of Product Development: A Review and Roadmap to Guide Applications.

OBJECTIVES: Early health technology assessment (eHTA) can be used to evaluate and optimize a medical product's value proposition and to inform go/no-go decisions by using health economic modeling, literature scanning, and stakeholder preference studies at an early stage of development. eHTA frameworks offer high-level guidance on conducting this complex, iterative, and multidisciplinary process. The objective of this study was to review and summarize existing eHTA frameworks, understood as systematic approaches to guide early evidence generation and decision making. METHODS: Using a rapid review methodology, we identified all relevant studies published in English, French, and Spanish from PubMed/MEDLINE and Embase until February 2022. We only included frameworks relevant to the preclinical and early clinical (phase I) stages of medical product development. RESULTS: From 737 reviewed abstracts, 53 publications describing 46 frameworks were selected for inclusion and classified into categories based on their scope: (1) criteria frameworks, which provide an overview of eHTA; (2) process frameworks, which offer stepwise guidance for conducting eHTA, including preferred methods; and (3) methods frameworks, which provide detailed descriptions of specific eHTA methods. Most of the frameworks did not specify their target users or the specific stage of technology development. CONCLUSIONS: Despite some variability and gaps found across existing frameworks, the structure provided by this review helps inform eHTA applications. Remaining challenges are the frameworks' limited accessibility to users without a background in health economics, poor distinctions being made among early lifecycle stages and technology types, and the inconsistent terminology used to describe eHTA in different contexts.

Mushroom ß-glucans: application and innovation for food industry and immunotherapy.

Among the most important sources of ß-glucans are edible and medicinal mushrooms. These molecules are components of the cellular wall of basidiomycete fungi (mushrooms) and can be extracted even from the basidiocarp as the mycelium and its cultivation extracts or biomasses. Mushroom ß-glucans are recognized by their potential effects as immunostimulants and immunosuppressants. They are highlighted as anticholesterolemic, anti-inflammatory, adjuvant in diabetes mellitus, mycotherapy for cancer treatment, as well as adjuvants for COVID-19 vaccines. Due to their relevance, several techniques of ß-glucans extraction, purification, and analysis have already been described. Despite the previous knowledge of ß-glucans' benefits for human nutrition and health, the main information about this topic refers to the molecular identification, properties, and benefits, as well as their synthesis and action on cells. Studies on biotechnology industry applications (product development) and the registered products of ß-glucans from mushrooms are still limited and more common for feed and healthcare. In this context, this paper reviews the biotechnological production of food products containing ß-glucans from basidiomycete fungi, focusing on food enrichment, and presents a new perspective on fungi ß-glucans' use as potential immunotherapy agents. KEY POINTS: • Mushrooms' ß-glucans for product development in the biotechnology industry • Biotechnological production of food products containing mushrooms' ß-glucans • Basidiomycete fungi ß-glucans are used as potential immunotherapy agents.

Evaluating the benefit of early patient and public involvement for product development and testing with small companies.

INTRODUCTION: There is a growing understanding of the benefits of patient and public involvement (PPI), and its evaluation, in research. An online version of the CUBE PPI evaluation framework has been developed. We sought to use the CUBE to evaluate the value of early PPI with two small healthcare companies during product development. METHODS: Contributors were recruited online and had lived experience of either type 1 diabetes or obesity. Two 1-h sessions were run with a company developing a smartphone application to manage diabetes (DEE-EM): one with young people (YP; n = 5) and one with parents (n = 7). Two 1-h sessions were run with a company developing a weight-loss product, both with adults (n = 7 in each session). Sessions were facilitated by an independent University researcher and attended by company representatives, who presented their product. One facilitator led the evaluation of the session by giving a demonstration of the CUBE and asking simple questions in the YP session. RESULTS: A high proportion of contributors completed the CUBE (80.5% DEE-EM; 93% Oxford Medical Products). Responses were positive to all four CUBE dimensions (in italics). Contributors felt there were diverse ways to contribute to the sessions, and that they had a strong voice to add to the discussion. Balance was achieved regarding whose concerns (public or company) led the agenda, and contributors felt that both companies would make changes based on the discussion. The supportive attitude of both companies resulted in most contributors feeling comfortable participating in PPI sessions with the industry, while recognising the profit-making aspect of their work. CONCLUSIONS: PPI with small healthcare companies is both feasible and worthwhile. The CUBE framework facilitated the evaluation of the interaction between experts in different knowledge spaces. We provide recommendations for future projects, including considerations of who should participate and the level of implicit endorsement of the product that participation implies. PATIENT OR PUBLIC CONTRIBUTION: People with lived experience of type 1 diabetes or obesity were invited to contribute to one of four PPI sessions, which they then evaluated. One contributor agreed to contribute to the analysis of the evaluation data and interpretation and preparation of the manuscript.

Potency Assays: The 'Bugaboo' of Stem Cell Therapy.

Substantially manipulated cell-based products for human use are considered medicines and therefore regulatory authorities require extensive characterisation in terms of identity, purity and potency. The latter critical quality attribute is probably the most challenging to identify and measure, requiring provision that potency assays should reflect the intended mechanism of action and demonstrate the drugs' biological effect. However, in most cases, the mechanisms involved are not fully understood, making the definition and validation of suitable potency tests difficult, a 'bugaboo' quest to be feared. Although it is evident that much work is still needed in the scientific arena, the present chapter focuses on strategies currently used by developers of cell- and gene-based therapies to demonstrate potency of innovative medicines, the regulatory framework and need for standardisation seeking to demystify critical factors to consider when designing a potency assay.

Medical Devices with Embedded Sensor Systems: Design and Development Methodology for Start-Ups.

Embedded systems have become a key technology for the evolution of medical devices. However, the regulatory requirements that must be met make designing and developing these devices challenging. As a result, many start-ups attempting to develop medical devices fail. Therefore, this article presents a methodology to design and develop embedded medical devices while minimising the economic investment during the technical risk stages and encouraging customer feedback. The proposed methodology is based on the execution of three stages: Development Feasibility, Incremental and Iterative Prototyping, and Medical Product Consolidation. All this is completed in compliance with the applicable regulations. The methodology mentioned above is validated through practical use cases in which the development of a wearable device for monitoring vital signs is the most relevant. The presented use cases sustain the proposed methodology, for the devices were successfully CE marked. Moreover, ISO 13485 certification is obtained by following the proposed procedures.

Key Contributions by the Swiss Tropical and Public Health Institute Towards New and Better Drugs for Tropical Diseases.

Thanks to its expertise in clinical research, epidemiology, infectious diseases, microbiology, parasitology, public health, translational research and tropical medicine, coupled with deeply rooted partnerships with institutions in low- and middle-income countries (LMICs), the Swiss Tropical and Public Health Institute (Swiss TPH) has been a key contributor in many drug research and development consortia involving academia, pharma and product development partnerships. Our know-how of the maintenance of parasites and their life-cycles in the laboratory, plus our strong ties to research centres and disease control programme managers in LMICs with access to field sites and laboratories, have enabled systems for drug efficacy testing in vitro and in vivo, clinical research, and modelling to support the experimental approaches. Thus, Swiss TPH has made fundamental contributions towards the development of new drugs - and the better use of old drugs - for neglected tropical diseases and infectious diseases of poverty, such as Buruli ulcer, Chagas disease, food-borne trematodiasis (e.g. clonorchiasis, fascioliasis and opisthorchiasis), human African trypanosomiasis, leishmaniasis, malaria, schistosomiasis, soil-transmitted helminthiasis and tuberculosis. In this article, we show case the success stories of molecules to which Swiss TPH has made a substantial contribution regarding their use as anti-infective compounds with the ultimate aim to improve people's health and well-being.

Editorial : Swiss TPH: 30 Years of R&D Towards New Drugs for Tropical Diseases.

The year 2023 marks the 80th anniversary of the Swiss Tropical and Public Health Institute (Swiss TPH). Associated with the University of Basel, Swiss TPH combines research, education and services, working across a value chain from innovation and validation to application to improve people's health and well-being. Around 700 staff and students work in Swiss TPH's new headquarters in an emerging life-science cluster in Allschwil, Switzerland, focusing on infectious and non-communicable diseases, environment, society and health as well as health systems and interventions. In this special issue of Chimia, we highlight 30 years of research and development (R&D) at Swiss TPH, deeply grounded in partnership, towards new drugs for tropical diseases.

Basel: A Hotspot for Drug Discovery and Development Against Poverty-Related Diseases.

In discussion with Lukas Meier from the Swiss Tropical and Public Health Institute (Swiss TPH), Lutz Hegemann, Head of Novartis Global Health and Sustainability and Marcel Tanner, President of the Swiss Academies of Arts and Sciences, give their opinions on the changes that occurred in drug discovery and development for poverty-related diseases over the past 30 years. They emphasise the power of public-private partnerships and provide their points of views on what needs to be done in the future to ensure that the poorest of the poor also have access to important therapies.

Repurposing Know-how for Drug Development: Case Studies from the Swiss Tropical and Public Health Institute.

In pursuing novel therapeutic solutions, drug discovery and development rely on efficiently utilising existing knowledge and resources. Repurposing know-how, a strategy that capitalises on previously acquired information and expertise, has emerged as a powerful approach to accelerate drug discovery and development processes, often at a fraction of the costs of de novo developments. For 80 years, collaborating within a network of partnerships, the Swiss Tropical and Public Health Institute (Swiss TPH) has been working along a value chain from innovation to validation and application to combat poverty-related diseases. This article presents an overview of selected know-how repurposing initiatives conducted at Swiss TPH with a particular emphasis on the exploration of drug development pathways in the context of neglected tropical diseases and other infectious diseases of poverty, such as schistosomiasis, malaria and human African trypanosomiasis.

Isolation, characterization, and utilization of wheat bran protein fraction for food application.

Wheat bran (WB), a low-cost industrial by-product, is a vital source of high-quality proteins, minerals, vitamins, and several bioactive compounds. The present study encompasses the identification of appropriate bran streams of a commercial roller flour mill (CRFM) essentially based on hector liter weight, (HLW), optimization of WB protein isolation process, amino acid characterization, rendering more emphasis on simple water-soluble albumins, having higher commercial viability, and its application in food formulation. Total WB protein was 16.18% protein, the sum of the extracted proteins viz. albumin (2.43%), a prolamin (2.47%), glutelin (5.25%), globulin (1.92%), and insoluble proteins (4.09%) was 12.08%. Following albumin extraction, residual WB was subjected to ultra-sonication which further increased albumin protein yield from 2.43 to 3.07%. The extracted WB albumin isolate (WBAI) was utilized to develop high protein bread having significantly high volume and protein content, compared to control bread. The structural and sensorial attributes of the developed bread were superior compared to control bread. Thus, WBAI has a tremendous scope as a natural, affordable potential inexpensive food improver/fortificant to address protein-energy malnutrition (PEM). The process has the great advantage of being eco-friendly, besides, residual bran can still be used as cattle feed, enhancing profitability and viability.

Review of protein intake and suitability of foods for protein-fortification in older adults in the UK.

Protein is a vital dietary component for combating negative health outcomes associated with malnutrition in older adults, including sarcopenia, functional decline and reduced quality of life. Yet, recommended daily protein intake is consistently unmet, as evidenced in the literature and reaffirmed in this review. Poor appetite is recognized as a major determinant of protein-energy undernutrition and thus fortification of regular food or drinks provides a flexible and relevant approach for older adults with reduced appetite. To increase the likelihood of fortified products being successfully incorporated into the diets of older adults, they must be adaptable to older adults eating patterns, cater for their preferences and take the specific age-related problems that complicate food intake into account. This paper aims to highlight older adults' current sources of protein, shopping habits, typical eating patterns and commonly consumed foods, and hence consider appropriate carriers for protein enrichment. Data were reanalyzed from a combination of freely available UK datasets, including the National Dietary and Nutrition Survey and the Food and You Survey, alongside data purchased from market research consultancy, Kantar. These insights draw attention to the potential suitability of foods for fortification purposes, with the ultimate objective to promote eating pleasure and prevent malnutrition.

Food and Drug Administration perspective: Advancing product development for non-healing chronic wounds.

The US Food and Drug Administration (FDA) understands that innovative product development is essential to addressing the unmet medical need of non-healing chronic wounds. Barriers to product development for non-healing chronic wounds may involve but are not limited to a dearth of biological models, challenges in drug delivery, challenges in clinical trial execution, and limited commercial viability. This perspective article discusses FDA's renewed focus on non-healing chronic wounds and outlines efforts to address identified barriers to product development for non-healing chronic wounds. In collaboration with key wound healing stakeholders including academia, professional associations, patient groups, reimbursement organizations and industry, FDA intends to help advance product development for non-healing chronic wounds for the ultimate betterment of patients.

Diagnostic waste: whose responsibility?

Waste management is notably absent from current discussions about efforts to improve access to diagnostics in low-and middle-income Countries (LMICs). Yet an increase in testing will inevitably lead to an increase in diagnostic waste, especially since many of the diagnostic tests designed for use in LMICs are single-use point-of-care tests. Diagnostic waste poses a threat to both human and environmental health. In this commentary we draw on our experience of diagnostic waste management in Sierra Leone and review current evidence on: the volume and impact of diagnostic waste in LMICs, existing health-care waste management capacity in LMICs, established national and international policies for improving health-care waste management, and opportunities for strengthening policy in this area. We argue that questions of safe disposal for diagnostics should not be an afterthought, only posed once questions of access have already been addressed. Moreover, responsibility for safe disposal of diagnostic waste should not fall solely on national health systems by default. Instead, consideration of the end-life of diagnostic products must be fully integrated into the diagnostic access agenda and greater pressure should be placed on manufacturers to take responsibility for the full life-cycle of their products.

Extensive growth and growth boundary model for non-proteolytic Clostridium botulinum - Evaluation and validation with MAP and smoked foods.

The growth inhibiting effect of lactic acid bacteria (LAB) on non-proteolytic Clostridium botulinum was studied. LAB had no significant effect on growth of C. botulinum and their effect was not included in the model to be evaluated. An available cardinal parameter growth and growth boundary model for non-proteolytic C. botulinum (Koukou et al., 2021; https://doi.org/10.1016/j.ijfoodmicro.2021.109162) was evaluated using a total of 822 time-to-toxin (TTT) formation data extracted from the scientific literature for seafood, poultry, vegetables and meat products. These data included smoked products and food stored in air, vacuum or modified atmosphere packaging (MAP) with added CO2. The available extensive model predicted TTT formation without bias (Bf-TTT value = 0.99) and with a reasonable accuracy (Af-TTT value = 1.76). The model was successfully validated for seafood and poultry products. This study substantially increased the range of applicability of the available growth and growth boundary model for non-proteolytic C. botulinum. The performed evaluation showed this model can be used to predict environmental conditions to prevent growth in seafood and poultry products including smoked fish and MAP foods. It is expected that this validated model will contribute to product development and innovation including new sodium reduced foods.

Clostridium sporogenes as surrogate for proteolytic C. botulinum - Development and validation of extensive growth and growth-boundary model.

An extensive cardinal parameter growth and growth boundary model for C. sporogenes, as a surrogate for proteolytic C. botulinum, was developed to include the inhibitory effect of 11 environmental factors. 626 maximum specific growth rates (µmax) in broth were generated to determine cardinal parameter values for the growth inhibiting effect of temperature, pH, NaCl/water activity (aw), organic acids (acetic, benzoic, citric, lactic, sorbic) and phosphate melting salts (ortho-, di- and tri-phosphates). µmax-values for C. sporogenes growing in well-characterized processed cheeses were used for product calibration (n = 10) and for product evaluation of the developed broth-model (n = 29). 112 growth/no-growth responses and including 104 µmax-values from the scientific literature for 58 different isolates of proteolytic and toxigenic C. botulinum (Group I) were used for further model evaluation. The developed model had less bias and a higher percentage of correct predictions than available models and was acceptable for processed cheese and good for meat products. The new and extensive model can predict combinations of environmental factors that prevent growth of C. sporogenes and of proteolytic C. botulinum. These predictions are expected to facilitate development or re-formulation of processed cheese and meat products where growth is prevented.

Total Design in the Design and Development Process of a Remotely Operated Vehicle (ROV) with Particular Consideration of Sensorization.

This paper provides a methodological proposal for the design and development process of a remotely operated vehicle (ROV). The design core and product design specifications (PDS) of Pugh's Total Design model are considered, with a focus on the early stages of the product design and development process. A modularization of the functional groups of an ROV is proposed, focusing attention on the sensor system. The main concepts regarding ROVs are presented, Pugh's Total Design model is explained, justifying the application interest in technological projects, a methodological proposal adapted to ROV projects is provided, based on Pugh's Total Design model, with special interest in the early stages of the new product development process (NPD), the suitability of applying our own model of industrial design engineering in an ROV system is analyzed, and the contribution of this study is evaluated, proposing future work and lines of research.

Embedded Sensor Systems in Medical Devices: Requisites and Challenges Ahead.

The evolution of technology enables the design of smarter medical devices. Embedded Sensor Systems play an important role, both in monitoring and diagnostic devices for healthcare. The design and development of Embedded Sensor Systems for medical devices are subjected to standards and regulations that will depend on the intended use of the device as well as the used technology. This article summarizes the challenges to be faced when designing Embedded Sensor Systems for the medical sector. With this aim, it presents the innovation context of the sector, the stages of new medical device development, the technological components that make up an Embedded Sensor System and the regulatory framework that applies to it. Finally, this article highlights the need to define new medical product design and development methodologies that help companies to successfully introduce new technologies in medical devices.