Manufacturing Challenges Research Articles

Non-contact targeted removal of remnant powder particles from additive manufacturing builds with nano-second laser pulsing

Post-production precision cleaning is one critical challenge in Additive Manufacturing (AM) production of high-value, critical parts/builds. A part shedding particle during its operational use could cause severe complications in critical applications such as medical devices and aerospace components. This study presents a non-contact precision particle removal procedure based on a novel Dry Laser Cleaning (DLC) framework. DLC utilizes the thermo-elastic wave generation/propagation and high-frequency surface acceleration fields to dislodge and remove remnant particles due to inertial forces from a well-defined (user-specified) cleaning zone in a non-contact manner, as opposed to cleaning the entire build surface, which could lead to undesirable re-deposition and re-location of particles as well as high cost. The removal of spherical Stainless Steel 316 L (SS316L) micro-particles commonly used in AM from polished, atomically flat Silicon (Si) wafer substrates with uniform high free surface energy using a nano-second laser pulse is experimentally and computationally investigated. In general, a rough surface has a lower average free surface energy; thus, its cleaning, compared to Si wafer, is less challenging. The data with the SS316-Si material pair offers a consistent baseline. In parallel to experiments, a fully-coupled thermo-mechanical finite element study is also conducted for transient surface acceleration simulations to predict the effectiveness of SS316L micro-particle removal from a Si wafer substrate with laser pulsation. It is observed that SS316L micro-particles with a diameter larger than 5.61 μm, 8.43 μm, and 12.24 μm can be removed entirely at 3 mm, 6 mm, and 9 mm distances from its epicenter, respectively. Accordingly, a work-of-adhesion of 990.8 mJ/m2 is selected between the SS316-Si material pair, consistent with the literature. The reported experiments and simulations demonstrate the potential of the proposed rapid precision particle removal procedure for cleaning critical powder-based AM builds, where the targeted removal of particles is essential for the safe and reliable operation of high-value builds and parts.

Recent progress and challenges for manufacturing and operating solid-state batteries for electric vehicles

Recent progress and challenges for manufacturing and operating solid-state batteries for electric vehicles

On the design of vehicle front-ends for pedestrian safety with the advanced Pedestrian Legform Impactor (aPLI)

The latest Euro NCAP Vulnerable Road Users Assessment Protocol (v11.3) introduces the advanced Pedestrian Legform Impactor (aPLI) to reduce the risk of lower extremity injury to pedestrians in a vehicle collision. The addition of femur injury criteria and the added simplified upper body mass, compared to its predecessor –the FlexPLI–, allows a more comprehensive assessment of passive pedestrian safety. However, this presents new challenges for vehicle manufacturers as these additions must be accounted for. We perform four sensitivity analyses at two test positions (centre and at the headlight) on two vehicles (compact car and SUV). Thereby, we investigate five design parameters that represent the main front-end components and identify that the vehicle type determines the sensitive design parameters significantly. Furthermore, we show that the influence of the lower stiffener and energy-absorbing foam diminishes compared to older legform impactors, while that of the bonnet increases.

High-density culturing of the dermal fibroblast cells on hydrogel-based soft microcarriers for cell therapy application

Dermal fibroblasts play a pivotal role in cell therapy, serving as versatile cells essential for tissue repair and regeneration. Their unique ability to produce extracellular matrix components contributes significantly to the efficacy and success of various cell-based therapies in treating skin-related conditions and wounds. Scaling up the production of dermal fibroblasts poses a challenge due to their limited lifespan in culture and the need to maintain their specialized functions over multiple generations. Bioreactors offer a promising solution by providing controlled environments that optimize cell growth, allowing for higher yields of dermal fibroblasts while preserving their functionality and minimizing the limitations associated with traditional culture methods. To overcome the critical challenges in large-scale cell manufacturing, we fine-tuned the composition of our existing smart microcarrier, Cytogel, and tailored its chemical and physical properties to cultivate dermal fibroblasts. The fibroblast cell attachment rate to the new optimized formulation is more than 90%, followed by 60% thermal detachment efficiency in 1 h. Additionally, cells harvested from Cytogel displayed superior CD90 expression and enhanced collagen production compared to fibroblasts cultured in tissue flasks in both static and dynamic bioreactor cultures. Overall, our developed hydrogel-based microcarriers exhibited significant promise for efficient cell expansion, offering a groundbreaking approach for industrial-scale cell culture for cell therapeutic applications.

Thermal, Microstructural, and Mechanical Analysis of Complex Lattice Structures Produced by Direct Energy Deposition.

Lattice structures have gained attention in engineering due to their lightweight properties. However, the complex geometry of lattice structures and the high melting temperature of metals present significant manufacturing challenges for the large-scale fabrication of these structures. Direct Energy Deposition (DED) methods, such as the Wire Arc Additive Manufacturing (WAAM) technique, appear to be an interesting solution for overcoming these limitations. This study provides a detailed analysis of the manufacturing process of carbon steel lattice structures with auxetic geometry. The study includes thermal analysis using infrared thermography, microstructural characterization through metallography, and mechanical evaluation via hardness and mechanical testing. The findings reveal the significant impact of heat input, thermal cycles, and deposition sequence on the morphology and mechanical properties of the lattice structures. Fast thermal cycles are related to areas with higher hardness values, smaller strut diameters, and porous formations, which shows that controlling heat input and heat dissipation is crucial for optimizing the properties of lattice structures produced using WAAM.

Mesenchymal stem cells biological and biotechnological advances: Implications for clinical applications

BackgroundMesenchymal stem cells (MSCs) are multipotent stem cells that are able to differentiate into multiple lineages including bone, cartilage, muscle and fat. They hold immunomodulatory properties and therapeutic ability to treat multiple diseases, including autoimmune and chronic degenerative diseases. In this article, we reviewed the different biological properties, applications and clinical trials of MSCs. Also, we discussed the basics of manufacturing conditions, quality control, and challenges facing MSCs in the clinical setting. MethodsExtensive review of the literature was conducted through the databases PubMed, Google Scholar, and Cochrane. Papers published since 2015 and covering the clinical applications and research of MSC therapy were considered. Furthermore, older papers were considered when referring to pioneering studies in the field. ResultsThe most widely studied stem cells in cell therapy and tissue repair are bone marrow-derived mesenchymal stem cells. Adipose tissue-derived stem cells became more common and to a lesser extent other stem cell sources e.g., foreskin derived MSCs. MSCs therapy were also studied in the setting of COVID-19 infections, ischemic strokes, autoimmune diseases, tumor development and graft rejection. Multiple obstacles, still face the standardization and optimization of MSC therapy such as the survival and the immunophenotype and the efficiency of transplanted cells. MSCs used in clinical settings displayed heterogeneity in their function despite their extraction from healthy donors and expression of similar surface markers. ConclusionMesenchymal stem cells offer a rising therapeutic promise in various diseases. However, their potential use in clinical applications requires further investigation.

Characterization of material flow behavior in friction stir welded AA2014 aluminum alloy joints

Abstract Steel rivets serve as a substitute material for connecting similar and dissimilar materials within the structural fabrication industries. However, the use of steel rivets can result in a significant increase in the structure’s weight and may trigger corrosion at the interface due to galvanic coupling. Combining dissimilar alloys through the fusion welding process poses numerous challenges for manufacturers and designers. A solid-state welding technique called friction stir welding (FSW) has been developed. FSW can effectively join materials without reaching their melting points, relying on severe plastic deformation and recrystallization to form a welded joint. The proper selection of the tool and process parameters is essential for achieving a sound weld. The findings of this study indicate that plastic deformation, material flow, and recrystallization play pivotal roles in the strength of the joint. This implies that FSW represents an ideal joining process for high-strength alloys and serves as a viable alternative to replace permanent joints like rivets.

Effect of CD22-directed CAR-T cells secreting anti-CD19 T cell engagers on control of leukemia progression compared to tandem anti-CD19/CD22 CAR-T cells.

2550 Background: Antigen-specific cancer immunotherapies, based on engineered T cells bearing chimeric antigen receptors (CARs) or the systemic administration of bispecific T cell-engagers (TCEs), have a significant impact on relapsed/refractory (R/R) B cell malignancies. However, a significant percentage of patients relapse following CAR-T or TCE therapy, with antigen loss accounting for up to one third of relapses/progressions. To avoid antigen loss after administration of single-targeted CAR-T cells and to minimize tumor escape, strategies targeting two antigens simultaneously have been developed and validated in both preclinical models and clinical trials. Nevertheless, despite lowering the risk of antigen loss, these strategies still have some limitations, mainly related to design and manufacturing challenges. Methods: In this context, we have generated the first dual-target strategy for hematological malignancies based on T cells bearing an anti-CD22 CAR and secreting an anti-CD19 T-cell engager antibody (CAR-STAb-T cells) and conducted a comprehensive preclinical study comparing its therapeutic potential with a previously validated anti-CD19/CD22 tandem CAR therapy (TanCAR-T) for B-cell acute lymphoblastic leukemia (B-ALL). Results: We have demonstrated in both short- and long-term assays, using contact and non-contact co-culture systems, that CAR-STAb-T cells efficiently redirect bystander T cells, resulting in enhanced cytotoxic activity compared to that exhibited by TanCAR-T cells at very low E:T ratios. In addition, CAR-STAb-T cells induce more potent and faster cytotoxic responses than TanCAR-T cells in both short- and long-term co-culture assays when reproducing antigen-downmodulated conditions in vitro. In vivo assays conducted in NSG mice transplanted with a B-ALL patient-derived xenograft (PDX), followed by intravenous injection of CAR-STAb-T or TanCAR-T cells under a T cell-limiting experimental setting, also showed that CAR-STAb-T cells maintained a tighter control of tumor progression than TanCAR-T cells in peripheral blood and bone marrow. Conclusions: In conclusion, we have demonstrated that the combination of a cell surface CAR and a soluble TCE recognizing different antigens may be advantageous over the use of conventional multi-targeted strategies based on cell surface-anchored receptors. Furthermore, we have proven that a small number of transduced CAR-STAb-T cells is sufficient to redirect non-transduced bystander T cells specifically and efficiently in the presence of leukemia cells, providing a significant advantage over current dual-targeted CAR-T cell therapies. CAR-STAb-T cells could therefore become an alternative to CAR-T therapies for the treatment of R/R B cell malignancies, especially in lymphodepleted patients with low T cell counts.

Molecular design of controllable recombinant adeno-associated virus (AAV) expression systems for enhanced vector production.

Recombinant adeno-associated virus (rAAV) is the leading vector for the delivery of gene therapies. However, low viral genome (VG) titers are common and the proportion of "full" capsids containing the therapeutic gene payload can be highly variable. The coordinated molecular design of plasmids encoding viral components and Helper functions remains a major challenge for rAAV manufacturing. Here we present the design of improved Rep/Cap and Helper plasmids for rAAV2/8 production, (i) a Rep/Cap expression vector harboring independently controllable rep and cap genes and (ii) an improved Helper plasmid harboring E4 gene deletion variants. First, an optimized Rep/Cap vector utilized a truncated p5 promoter, a p5 cis-regulatory element at the 3' end in combination with a heterologous promoter to drive Cap expression and an additional copy of the rep52/40 gene to overexpress short Rep proteins. We demonstrate that Rep78 is essential for efficient rAAV2/8 production in HEK293 cells, and a higher ratio of short Rep to long Rep proteins enhances genome packaging. Second, we identified regulators and open reading frames within the Helper plasmid that contribute to increased rAAV2/8 production. While L4-33k/22k is integral to optimal production, the use of E4orf6-6/7 subset significantly enhanced VG titer. Together, an optimal combination of engineered Rep/Cap and Helper plasmid variants increased VG titer by 3.1-fold. This study demonstrates that configuring and controlling the expression of the different AAV genetic elements contributes toward high rAAV production and product quality (full/empty capsid ratio).

Effects of high gravity on properties of parts fabricated using material extrusion system by additive manufacturing

Additive manufacturing (AM) has gained significant attention in recent years owing to its ability to fabricate intricate shapes and structures that are often challenging or unattainable using conventional manufacturing techniques. This high-quality development trend entails higher requirements for the structural design of 3D printers. In this study, polylactic acid (PLA) and acrylonitrile butadiene styrene (ABS) filaments were fed through a heated extrusion nozzle, which melted the material and deposited it onto a build platform. This study's objectives are high-gravitational material extrusion (HG-MEX) systems development, analyzing the high gravity influences on the flow behavior of materials during extrusion, and understanding the effects of gravitational on material flow and overall extrusion performance. HG-MEX systems have great potential for addressing various challenges in additive manufacturing, such as precise manufacturing. The highlight of the progress is that we developed an HG-MEX system and applied surface science to material extrusion in different gravity. We established a system and obtained results on different gravity, we analyzed the analogy between different gravity phenomena. We analyzed the interplay between the behavior of the fabricated parts and gravity. We analyzed high gravity effects on extrusion processes. The results confirmed the characteristics and feasibility of the developed system. The results suggest that a material extrusion line operating under 15 G conditions resulted in better printing quality compared to one operating under 1 G conditions. This observation implies that high gravity had a positive effect on the extrusion process, leading to improved material extrusion performance.

Fast Pareto set approximation for multi-objective flexible job shop scheduling via parallel preference-conditioned graph reinforcement learning

The Multi-Objective Flexible Job Shop Scheduling Problem (MOFJSP) is a complex challenge in manufacturing, requiring balancing multiple, often conflicting objectives. Traditional methods, such as Multi-Objective Evolutionary Algorithms (MOEA), can be time-consuming and unsuitable for real-time applications. This paper introduces a novel Graph Reinforcement Learning (GRL) approach, named Preference-Conditioned GRL, which efficiently approximates the Pareto set for MOFJSP in a parallelized manner. By decomposing the MOFJSP into distinct sub-problems based on preferences and leveraging a parallel multi-objective training algorithm, our method efficiently produces high-quality Pareto sets, significantly outperforming MOEA methods in both solution quality and speed, especially for large-scale problems. Extensive experiments demonstrate the superiority of our approach, with remarkable results on large instances, showcasing its potential for real-time scheduling in dynamic manufacturing environments. Notably, for large instances (50 × 20), our approach outperforms MOEA baselines with remarkably shorter computation time (less than 1% of that of MOEA baselines). The robust generalization performance across various instances also highlights the practical value of our method for decision-makers seeking optimized production resource utilization.

Configuration of last-mile distribution networks for an encroaching manufacturer

AbstractThe surge of e-commerce has revolutionized distribution channels, escalating from simple single-channel frameworks to complex multi-channel and omni-channel networks. In particular developments in information technology and rising customer expectations have popularized the transition from multi- to omni-channel distribution, where the classic brick-and-mortar stores can also be part of the omni-channel distribution strategy. This evolution poses intricate challenges for manufacturers, especially in the integration and optimization of these channels. Thus, there is a strong need for an in-depth analysis of how manufacturers navigate the transition across diverse distribution channels to meet the varying needs of different customer segments. To this end, we investigate single-, multi-, and omni-channel distribution strategies for the case of a manufacturer selling both standard and customized products to different customer segments with varying preferences. A central contribution of this research is the creation of an integrated optimization model that resolves a location-routing problem, designing a complex and realistic supply chain configuration suitable for an omni-channel distribution system. This model strategically serves to fragmented customer demands through multiple shopping and delivery options. The outcomes of our study indicate that an omni-channel distribution system is a viable approach, capable of serving more customer segments while simultaneously minimizing logistics costs. In addition, we offer a detailed analysis of the cost implications of in-store pickup versus home-delivery options, providing a comprehensive evaluation of their respective impacts on total logistics costs and customer responsiveness.

Developing a virtual reality and AI-based framework for advanced digital manufacturing and nearshoring opportunities in Mexico.

The growing expansion of the manufacturing sector, particularly in Mexico, has revealed a spectrum of nearshoring opportunities yet is paralleled by a discernible void in educational tools for various stakeholders, such as engineers, students, and decision-makers. This paper introduces a state-of-the-art framework, incorporating virtual reality (VR) and artificial intelligence (AI) to metamorphose the pedagogy of advanced manufacturing systems. Through a case study focused on the design, production, and evaluation of a robotic platform, the framework endeavors to offer an exhaustive educational experience via an interactive VR environment, encapsulating (1) Robotic platform system design and modeling, enabling users to immerse themselves in the design and simulation of robotic platforms under varied conditions; (2) Virtual manufacturing company, presenting a detailed virtual manufacturing setup to enhance users' comprehension of manufacturing processes and systems, and problem-solving in realistic settings; and (3) Product evaluation, wherein users employ VR to meticulously assess the robotic platform, ensuring optimal functionality and customer satisfaction. This innovative framework melds theoretical acumen with practical application in advanced manufacturing, preparing entities to navigate Mexico's manufacturing sector's vibrant and competitive nearshoring landscape. It creates an immersive environment for understanding modern manufacturing challenges, fostering Mexico's manufacturing sector growth, and maximizing nearshoring opportunities for stakeholders.

Generation of allogeneic CAR-NKT cells from hematopoietic stem and progenitor cells using a clinically guided culture method.

Cancer immunotherapy with autologous chimeric antigen receptor (CAR) T cells faces challenges in manufacturing and patient selection that could be avoided by using 'off-the-shelf' products, such as allogeneic CAR natural killer T (AlloCAR-NKT) cells. Previously, we reported a system for differentiating human hematopoietic stem and progenitor cells into AlloCAR-NKT cells, but the use of three-dimensional culture and xenogeneic feeders precluded its clinical application. Here we describe a clinically guided method to differentiate and expand IL-15-enhanced AlloCAR-NKT cells with high yield and purity. We generated AlloCAR-NKT cells targeting seven cancers and, in a multiple myeloma model, demonstrated their antitumor efficacy, expansion and persistence. The cells also selectively depleted immunosuppressive cells in the tumor microenviroment and antagonized tumor immune evasion via triple targeting of CAR, TCR and NK receptors. They exhibited a stable hypoimmunogenic phenotype associated with epigenetic and signaling regulation and did not induce detectable graft versus host disease or cytokine release syndrome. These properties of AlloCAR-NKT cells support their potential for clinical translation.

Point-of-care testing: a critical analysis of the market and future trends

Point-of-care testing (POCT) involves conducting diagnostic tests outside the laboratory. These tests are utilized for their quick and reliable results in detecting chronic diseases and acute infections. We examined the historical market value trends of the POCT industry and projected its future growth. POCT devices offer several advantages, such as portability, no specific storage requirements, and simplicity of use. However, issues such as inaccurate results can reduce demand for POCT compared to traditional laboratory testing alternatives. While the benefits of POCT are clear, it’s important to acknowledge the challenges. The accuracy of POCT devices can be compromised due to factors such as user error, environmental conditions, and limitations in technology. Furthermore, the cost-effectiveness of these devices is often a concern, particularly in resource-limited settings. The regulatory landscape for POCT is also complex and varies by region, which can pose challenges for manufacturers and end-users. Improvements in POCT devices’ sensitivity, specificity, cost, and turnaround time for test results could enhance their utility. Enhancements to a POCT device should be considered if they are economically viable and lead to a significant increase in demand. Our financial analysis of the POCT market revealed a positive growth trend. We identified potential areas for growth that could help the industry progress and expand in line with its projected growth in the coming years. The industry could focus on integrating intelligent technologies into POCT devices and collaborating with the innovative technology sector to increase revenue. It could also develop more sensitive and accurate POCT devices for non-communicable diseases. Another potential area of growth is in diseases that require continuous patient monitoring but where conventional clinical testing is time-consuming. Enhancing the POCT devices used in these areas could revolutionize medical diagnosis and potentially save many lives, provided they meet clinical standards.

A Critical Review on Recent Progress of Solution‐Processed Monolayer Assembly of Nanomaterials and Applications

AbstractThe rapid development in nanotechnology has necessitated accurate and efficient assembly strategies for nanomaterials. Monolayer assembly of nanomaterials (MAN) represents a challenging and important architecture to manufacture and is critical in understanding interactions among nanomaterials, solvents, and substrates. MAN enables highly tunable performance in electronic and photonic devices. This review summarizes the recent progress on the methods to achieve MAN and discusses important control factors. Moreover, the importance of MAN is elaborated by a broad range of applications in electronics and photonics. In the end, the opportunities as well as challenges in manufacturing and new applications are outlooked.

Application of carbon fiber composite materials in aircraft

Carbon fiber composite is a material with excellent mechanical properties. Compared with other high-performance fiber materials, carbon fiber composites have the advantages of high strength and high modulus even at ultra-high temperatures. In addition, the carbon fiber composite material also has excellent electrical and thermal conductivity and electromagnetic shielding performance. Carbon fiber composites are widely used in the aircraft manufacturing industry due to their incomparable performance with other composite materials. In recent years, the amount of carbon fiber composite materials in newly developed aircraft products has reached more than 50%. This paper aims to explore the application of carbon fiber in aircraft, and to reflect the importance of carbon fiber composite materials by comparing models that use composite materials and models that do not use composite materials. The study explores the application of carbon fiber composite materials in aircraft through a comprehensive literature analysis and review. Key findings indicate significant advantages of these materials in enhancing aircraft performance, including reduced weight and increased strength. The paper also discusses the challenges in manufacturing and environmental impacts, offering insights into future research directions for sustainable aviation technologies.

Comprehensive investigation on crushing performance and collapse mechanism of friction stir welded aluminium honeycomb by damage modeling

Aluminium honeycomb, renowned for its energy-absorption capabilities, poses significant manufacturing challenges. To address adhesive failure and premature collapse in traditional aluminium honeycomb, this study presents a novel approach - friction stir welded aluminium honeycomb. Traditional honeycombs can lose up to 50 % of their strength during low-velocity impacts, underscoring the need to comprehend the crashworthiness and crushing behaviour of this innovative solution. The study employs a robust finite element framework to predict crashworthiness parameters and deformation under flatwise compression. Enhanced with damage criterion, it offers more realistic predictions, indicating no debonding in welded regions. Most energy is dissipated through plastic folding, making it suitable for high-energy absorption applications. Damage initiates at the corner of the flanges due to stress concentration, minimized by a design modification to barrel-shaped honeycomb, boosting crushing strength by 21 %. This study aids in predicting responses of friction stir welded aluminium honeycombs for design optimization.

REGULATORY CHALLENGES AND LANDSCAPES OF MONOCLONAL ANTIBODY REGISTRATION: GLOBAL OUTLOOK

Objective: This review aims to illuminate the unprecedented growth and versatile therapeutic landscape of monoclonal antibody (mAb) products, highlighting their significant impact on diverse medical fields such as oncology, septicemia treatment, infection management, and substance abuse disorder interventions. This review outlines the challenges associated with the development, manufacturing, and regulatory approval of monoclonal antibodies, emphasizing the need for diligent attention to overcome these complexities. The review comprehensively examines the historical evolution and therapeutic applications of monoclonal antibodies, emphasizing their potent and versatile characteristics that have enabled successful interventions in challenging regulatory approvals. It delves into the critical considerations in manufacturing, regulatory navigation, and the strategic integration of expedited approval pathways, providing a holistic understanding of the intricate terrain of innovation, clinical translation, and impactful patient care in the realm of monoclonal antibody products. Monoclonal antibodies have significantly advanced medical treatment in various domains, revolutionizing cancer therapy, offering new avenues for septicemia management, augmenting the arsenal against infections, and opening novel pathways for addressing substance abuse disorders. Their development and regulatory approval are associated with challenges of scientific innovation, manufacturing, and regulatory compliance. Despite the challenges, monoclonal antibodies have demonstrated remarkable potential in addressing complex medical conditions. The review serves as a compass, guiding researchers, clinicians, and regulatory authorities through the intricate terrain of monoclonal antibody innovation and clinical translation. It emphasizes the need for diligent attention to overcome the complexities associated with their development and regulatory approval while highlighting their significant impact on advancing patient care.

Addressing the safety of new food sources and production systems.

New food sources and production systems (NFPS) are garnering much attention, driven by international trade, changing consumer preferences, potential sustainability benefits, and innovations in climate-resilient food production systems. However, NFPS can introduce new challenges for food safety agencies and food manufacturers. Most food safety hazards linked to new foods have been identified in traditional foods. However, there can be some food safety challenges that are unique to new foods. New food ingredients, inputs, and processes can introduce unexpected contaminants. To realize the full potential of NFPS, there is a need for stakeholders from governments, the food industry, and the research community to collectively work to address and communicate the safety of NFPS products. This review outlines known food safety hazards associated with select NFPS products on the market, namely, plant-derived proteins, seaweeds, jellyfish, insects, microbial proteins, as well asfoods derived from cell-based food production, precision fermentation, vertical farming, and 3D food printing. We identify common elements in emerging NFPS regulatory frameworks in various countries/regions. Furthermore, we highlight current efforts in harmonization of terminologies, use of recent scientific tools to fill in food safety knowledge gaps, and international multi-stakeholder collaborations to tackle safety challenges. Although there cannot be a one-size-fits-all approach when it comes to the regulatory oversight for ensuring the safety of NFPS, there is a need to develop consensus-based structured protocols or workflows among stakeholders to facilitate comprehensive, robust, and internationally harmonized approaches. These efforts increase consumers' confidence in the safety of new foods and contribute toward fair practices in the international trade of such foods.