Safe Manufacturing Research Articles

Harnessing exosomes: the future of drug delivery across biological barriers

A unique class of extracellular vesicles (EVs), exosomes range in size from 30 to 150 nm. They frequently travel to distant tissues inside an organism and are essential for cellular communication. Exosomes are useful in the creation of targeted therapeutics for the delivery of macromolecules and drug delivery systems because of their notable natural cell-targeting properties. Because of these features, exosomes are becoming more and more recognized as bio-derived vehicles for delivering and protecting therapeutic agents to treat various kinds of cancers (lung, pancreatic, colon, brain, and breast), viral diseases (AIDS, hepatitis B), and bacterial infections (toxoplasmosis, salmonellosis). According to research, the natural payload of exosomes can either exacerbate or lessen the severity of an illness. This calls for meticulous planning, which includes determining the exosomes' composition and source. As a result, approaches for assessing the features of intact exosomes as well as dependable and economical ways for isolating them are essential. However, several obstacles prevent them from being used in therapeutic settings. Exosome stabilization, safe and effective manufacture in large enough quantities, effective loading of therapeutic drugs into them, maximizing their removal from circulation, and scaling up production from research to clinical settings are some of these. A better comprehension of the molecular processes controlling exosome transport and activity is crucial for clinical applications. This review focuses on methods for isolating and characterizing exosomes, explores their potential as drug delivery platforms, and examines strategies to enhance therapeutic outcomes and improve their stability.

Light management in Cu2ZnSnSe4 solar cells with ZnO:Al periodic sub-wavelength architectures

This study used a vacuum deposition technique to manufacture Cu₂ZnSnSe₄ (CZTSe) solar cells, providing a scalable and safe manufacturing approach for low-cost, high-performance photovoltaic technology. Additionally, nanoimprint lithography was successfully employed to fabricate two types of periodic sub-wavelength architectures on the surface of CZTSe solar cells, serving as anti-reflective layers and further enhancing their conversion efficiency. The research demonstrates that when the surface architecture of the CZTSe solar cells is Nano-hill, it exhibits superior gradient refractive index and optimal anti-reflective properties, consistent with simulation results. For CZTSe solar cells with this surface architecture, the average reflectance decreased from the pristine 9.86 %–7.34 %, and at an incident light angle of 60°, the reflectance dropped from 17.99 % to 9.53 %, demonstrating the architecture's omnidirectional anti-reflective capability. The periodic sub-wavelength architectures fabricated in this study enhanced the efficiency of the solar cells from 3.68 % to 6.66 %, not only improving conversion efficiency but also showcasing the potential for comprehensive anti-reflective layers, interface repair, and continuous processing. This research not only contributes to optical design but also holds significant importance for the future development of CZTS(Se) technology.

A Review of CIGS Thin Film Semiconductor Deposition via Sputtering and Thermal Evaporation for Solar Cell Applications

Over the last two decades, thin film solar cell technology has made notable progress, presenting a competitive alternative to silicon-based solar counterparts. CIGS (CuIn1−xGaxSe2) solar cells, leveraging the tunable optoelectronic properties of the CIGS absorber layer, currently stand out with the highest power conversion efficiency among second-generation solar cells. Various deposition techniques, such as co-evaporation using Cu, In, Ga, and Se elemental sources, the sequential selenization/sulfidation of sputtered metallic precursors (Cu, In, and Ga), or non-vacuum methods involving the application of specialized inks onto a substrate followed by annealing, can be employed to form CIGS films as light absorbers. While co-evaporation demonstrates exceptional qualities in CIGS thin film production, challenges persist in controlling composition and scaling up the technology. On the other hand, magnetron sputtering techniques show promise in addressing these issues, with ongoing research emphasizing the adoption of simplified and safe manufacturing processes while maintaining high-quality CIGS film production. This review delves into the evolution of CIGS thin films for solar applications, specifically examining their development through physical vapor deposition methods including thermal evaporation and magnetron sputtering. The first section elucidates the structure and characteristics of CIGS-based solar cells, followed by an exploration of the challenges associated with employing solution-based deposition techniques for CIGS fabrication. The second part of this review focuses on the intricacies of controlling the properties of CIGS-absorbing materials deposited via various processes and the subsequent impact on energy conversion performance. This analysis extends to a detailed examination of the deposition processes involved in co-evaporation and magnetron sputtering, encompassing one-stage, two-stage, three-stage, one-step, and two-step methodologies. At the end, this review discusses the prospective next-generation strategies aimed at improving the performance of CIGS-based solar cells. This paper provides an overview of the present research state of CIGS solar cells, with an emphasis on deposition techniques, allowing for a better understanding of the relationship between CIGS thin film properties and solar cell efficiency. Thus, a roadmap for selecting the most appropriate deposition technique is created. By analyzing existing research, this review can assist researchers in this field in identifying gaps, which can then be used as inspiration for future research.

Safe and reconfigurable manufacturing: safety aware multi-agent control for Plug & Produce system

Plug & Produce aims to revolutionize manufacturing by enabling seamless machine integration into production processes without extensive programming. This concept, leveraging multi-agent systems (MAS), offers increased flexibility and faster production ramp-up times after reconfiguration. As automated manufacturing moves towards greater human integration, this paper addresses safe operation within the Plug & Produce concept. The main safety challenge arises from autonomous decision-making, as agents in the MAS lack awareness of the risk consequences of their behavior. Additionally, the difficulty of perceiving the system’s exact behavior leads to the implementation of overly restrictive safety measures. This limits the system’s flexibility and ability to make decisions for efficient production. This paper proposes a method utilizing multi-agent control to conduct automatic safety analysis and reason task allocations to avoid risks. The method’s benefits are the generation of control actions that comply with safety requirements during operation, eliminating the need for overly restrictive safety measures and allowing more effective equipment utilization. The method’s benefit is illustrated through a manufacturing scenario with two different configurations: one using a hazardous machine and the other using a less hazardous one. Formal verification using the model checker NuSMV demonstrated that safety requirements were satisfied in both configurations, without the need for manual modifications of the safety control system after reconfiguration. The results for this specific manufacturing scenario showed that there are more reachable states (20 states) in the safer second configuration, compared to the first configuration (16 states). This means that the presented control strategy dynamically adjusts the system’s behavior to confirm safety. Hence, this method maintains safety without fixed safety rules that limit the operations.

High sensitivity Mach-Zehnder interferometric fiber-optic humidity sensor based on multimode interference enhancement

Variations in humidity can significantly disrupt the proper functioning of precision instruments and meters across various industrial, medical, and scientific applications, thereby necessitating real-time humidity monitoring. Here, a high sensitivity fiber-optic relative humidity (RH) sensor based on Mach-Zender interferometer (MZI) is proposed and demonstrated. The humidity sensor consists of single-mode fiber (SMF), peanut structure (PS), and multi-mode fiber (MMF). A multi-mode interference (MMI) enhanced fiber-optic MZI was constructed using a SMF-PS-SMF-MMF-SMF-PS-SMF cascade structure to detect small changes in the refractive index (RI) and expansion force of gelatin film caused by humidity variation. PS, as a beam splitter and combiner of MZI, provides the possibility for simple, economical, and efficient manufacturing of the fiber-based part of humidity sensors. The addition of MMF will excite higher-order core and cladding modes, laying the foundation for achieving high-sensitivity fiber-optic humidity sensors. The fiber-optic RH sensor prototype demonstrate a high sensitivity of about 0.633 nm/% RH in the RH range of 50 % RH to 80 % RH, and a low temperature cross-sensitivity of 0.165 % RH/°C. This sensor has the advantages of safe and easy manufacturing process, low manufacturing cost, and high sensitivity, providing continuous high accuracy humidity measurement results for humidity sensing in different fields.

Fabrication, characterization, and bioactivity of self-assembled carrier-free colloidal dispersions from Citrus × Limon ‘Rosso’ essential oil and tea polyphenols

Carrier-free nanodelivery systems are fully self-assembled from active ingredients through interactions, offering the advantages of green, safe, and large-scale manufacturing. To improve the dispersion of Citrus × limon ‘Rosso’ peel essential oil (CEO) in water and boost the biological activity of CEO and tea polyphenols (TP), self-assembled CEO-TP colloidal dispersions (CEO-TP Colloids) were fabricated through sonication without surfactants or carriers. The optimal CEO and TP concentrations in the CEO-TP Colloids were determined to be 10.0 and 20.0 mg/mL by particle size and stability analyzer, respectively. The CEO self-assembled with TP to form spherical nanoparticles through hydrophobic and hydrogen-bonding interactions, whereas the CEO in CEO-TP Colloids weakened TP intramolecular aggregation. Meanwhile, the CEO-TP Colloids showed synergistic effects with better antibacterial, cellular antioxidant, and anti-inflammatory activities than single components. This study opens up the possibility of carrier-free co-delivery of hydrophobic and hydrophilic active components developed into food-grade formulations with multiple bioactivities.

Possible Strategies to Reduce the Tumorigenic Risk of Reprogrammed Normal and Cancer Cells.

The reprogramming of somatic cells to pluripotent stem cells has immense potential for use in regenerating or redeveloping tissues for transplantation, and the future application of this method is one of the most important research topics in regenerative medicine. These cells are generated from normal cells, adult stem cells, or neoplastic cancer cells. They express embryonic stem cell markers, such as OCT4, SOX2, and NANOG, and can differentiate into all tissue types in adults, both in vitro and in vivo. However, tumorigenicity, immunogenicity, and heterogeneity of cell populations may hamper the use of this method in medical therapeutics. The risk of cancer formation is dependent on mutations of these stemness genes during the transformation of pluripotent stem cells to cancer cells and on the alteration of the microenvironments of stem cell niches at genetic and epigenetic levels. Recent reports have shown that the generation of induced pluripotent stem cells (iPSCs) derived from human fibroblasts could be induced using chemicals, which is a safe, easy, and clinical-grade manufacturing strategy for modifying the cell fate of human cells required for regeneration therapies. This strategy is one of the future routes for the clinical application of reprogramming therapy. Therefore, this review highlights the recent progress in research focused on decreasing the tumorigenic risk of iPSCs or iPSC-derived organoids and increasing the safety of iPSC cell preparation and their application for therapeutic benefits.

Implantación de un sistema de trazabilidad y elaboración segura de medicamentos en la sala blanca

ObjectiveTo describe the process of implementing a traceability and safe drug manufacturing system in the clean room of a Pharmacy Service to increase patient safety, in accordance with current legislation. MethodsThe process was carried out between September 2021 and July 2022. The software program integrated all the recommended stages of the manufacturing process outlined in the “Good Practices Guide for Medication Preparation in Pharmacy Services” (GBPP). The following sections were parameterized in the software program: personnel, facilities, equipment, starting materials, packaging materials, standardized work procedures, and quality controls. ResultsA total of 50 users, 4 elaboration areas and 113 equipments were included. 435 components were parameterized (195 raw materials and 240 pharmaceutical specialties), 54 packaging materials, 376 standardized work procedures (123 of them corresponding to sterile medicines and 253 to non-sterile medicines, of which 52 non-sterile were dangerous), in addition 17 were high risk, 327 medium risk, 32 low risk, and 13 quality controls. ConclusionsThe computerization of the production process has allowed the implementation of a traceability and secure drug manufacturing system in a controlled environment in accordance with current legislation.

1,2,3-Triazole Synthesis: Development of Safe and Effective Batch and Continuous Manufacturing Processes

1,2,3-Triazole Synthesis: Development of Safe and Effective Batch and Continuous Manufacturing Processes

Piper chaba Stem Extract Facilitated the Synthesis of Iron Oxide Nanoparticles as an Adsorbent to Remove Congo Red Dye.

In this study, a straightforward, eco-friendly, and facile method for synthesizing iron oxide nanoparticles (IONPs) utilizing Piper chaba steam extract as a reducing and stabilizing agent has been demonstrated. The formation of stable IONPs coated with organic moieties was confirmed from UV-vis, FTIR, and EDX spectroscopy and DLS analysis. The produced IONPs are sufficiently crystalline to be superparamagnetic having a saturation magnetization value of 58 emu/g, and their spherical form and size of 9 nm were verified by XRD, VSM, SEM, and TEM investigations. In addition, the synthesized IONPs exhibited notable effectiveness in the removal of Congo Red (CR) dye with a maximum adsorption capacity of 88 mg/g. The adsorption kinetics followed pseudo-second-order kinetics, meaning the adsorption of CR on IONPs is mostly controlled by chemisorption. The adsorption isotherms of CR on the surface of IONPs follow the Langmuir isotherm model, indicating the monolayer adsorption on the homogeneous surface of IONPs through adsorbate-adsorbent interaction. The IONPs have revealed good potential for their reusability, with the adsorption efficiency remaining at about 85% after five adsorption-desorption cycles. The large-scale, safe, and cost-effective manufacturing of IONPs is made possible by this environmentally friendly process.

CO2-Mediated Alkali-Neutralization Curdlan Hydrogels for Potential Wound Healing Application.

Physical hydrogels of natural polysaccharides are considered as ideal candidates for wound dressing due to their natural biological activity and no harmful cross-linking agents. However, it remains a challenge to fabricate such hydrogel dressings in a facile and low-cost way. Herein, we reported an easy and cost-effective method to construct CO2-mediated alkali-neutralization Curdlan (CR) hydrogels without using an external cross-linking agent. Two types of hydrogels (denoted as CR-NaOH and CR-Na3PO4, respectively) were fabricated by dissolving CR powders in a NaOH or Na3PO4 aqueous solution, followed by keeping the CR alkaline solutions in air. The obtained pure CR hydrogels possessed a tunable porous structure with walls containing different forms of nanofibrils. These hydrogels exhibited much higher gel strength by comparison with the gels prepared by conventional heating treatment. They were flexible, stretchable, twistable, and conformable to arbitrarily curved skins. Moreover, they exhibited ideal swellability, proper degradability, and water vapor transmission rate, and their physicochemical properties were closely related to CR concentration in the alkaline solution. These two hydrogels also supported the growth of L929 cells. Importantly, studies on wound healing revealed that both 3CR-NaOH and 3CR-Na3PO4 hydrogels were capable of accelerating the wound healing process through recruiting more macrophages/fibroblasts, inducing more collagen deposition and neovascularization (α-SMA and CD31) without carrying any exogenous bioactive components. In conclusion, the present work not only reported promising materials for application in wound therapy but also offered a facile and safe manufacturing procedure for generating pure CR physical hydrogels with better performance.

Recombinant T7 RNA polymerase production using ClearColi BL21(DE3) and animal-free media for in vitro transcription.

In vitro transcription (IVT) using T7 RNA polymerase (RNAP) is integral to RNA research, yet producing this enzyme in E. coli presents challenges regarding endotoxins and animal-sourced toxins. This study demonstrates the viable production and characterization of T7 RNAP using ClearColi BL21(DE3) (an endotoxin-free E. coli strain) and animal-free media. Compared to BL21(DE3) with animal-free medium, soluble T7 RNAP expression is ~50% lower in ClearColi BL21(DE3). Optimal soluble T7 RNAP expression in flask fermentation is achieved through the design of experiments (DoE). Specification and functional testing showed that the endotoxin-free T7 RNAP has comparable activity to conventional T7 RNAP. After Ni-NTA purification, endotoxin levels were approximately 109-fold lower than T7 RNAP from BL21(DE3) with animal-free medium. Furthermore, a full factorial DoE created an optimal IVT system that maximized mRNA yield from the endotoxin-free and animal-free T7 RNAP. This work addresses critical challenges in recombinant T7 RNAP production through innovative host and medium combinations, avoided endotoxin risks and animal-derived toxins. Together with an optimized IVT reaction system, this study represents a significant advance for safe and reliable reagent manufacturing and RNA therapeutics. KEY POINTS: • Optimized IVT system maximizes mRNA yields, enabling the synthesis of long RNAs. • Novel production method yields endotoxin-free and animal-free T7 RNAP. • The T7 RNAP has equivalent specifications and function to conventional T7 RNAP.

MOLECULAR IDENTIFICATION OF BACTERIAL SPECIES IN STREET VENDED CHOLAY CHAT USING 16S RRNA GENE

The contamination of pathogenic microbes in street vended foods is a serious public health concern associatedwith foodborne illnesses (FBIs). The street vended Cholay Chat (SVCC) is a popular savory chickpea-basedready-to-eat food in Pakistan. The microbial quality of 18 SVCC samples was assessed through conventional andmolecular identification. A total of three (03) bacterial species (i.e., Bacillus cereus, Macrococcus caseolyticusand Staphylococcus sciuri) were characterized via phenotypic and biochemical analysis in SVCC. Among them,B. cereus remained highly prevalent (88.88%) followed by M. caseolyticus (61.11%) and S. sciuri (11.11%). Thepolymerase chain reaction (PCR) based DNA amplification of the 16S rRNA gene and sequencing of isolatedbacterial species were performed. The BLASTn analysis revealed that sequences were significantly aligned withB. cereus (97.38 %), M. caseolyticus (93.16%), and S. sciuri (97.21%). It is concluded that the microbial qualityof SVCC is highly detrimental and thus is liable to cause FBIs among consumers. Therefore, safe food handlingand manufacturing practices must be mandatorily assured by street food vendors to lessen the burden of FBIsamong consumers

TRNA therapeutics for genetic diseases.

Transfer RNAs (tRNAs) have a crucial role in protein synthesis, and in recent years, their therapeutic potential for the treatment of genetic diseases - primarily those associated with a mutation altering mRNA translation - has gained significant attention. Engineering tRNAs to readthrough nonsense mutation-associated premature termination of mRNA translation can restore protein synthesis and function. In addition, supplementation of natural tRNAs can counteract effects of missense mutations in proteins crucial for tRNA biogenesis and function in translation. This Review will present advances in the development of tRNA therapeutics with high activity and safety in vivo and discuss different formulation approaches for single or chronic treatment modalities. The field of tRNA therapeutics is still in its early stages, and a series of challenges related to tRNA efficacy and stability in vivo, delivery systems with tissue-specific tropism, and safe and efficient manufacturing need to be addressed.

Sustainable pathways to generate hydrogen: A thermodynamic view

We hereby share our perspective and experience regarding hydrogen thermodynamics. The thermodynamic modeling of hydrogen and hydrogen-containing mixtures seen from a historical perspective, beginning in 1979 with the publication of Daubert and Graboski on the modification of SRK EoS to systems containing hydrogen, up to nowadays where different tools as molecular simulations are in place, is shortly presented. The selected milestones are directly connected with the vision of the company to be one of the largest low-carbon hydrogen technology licensors in the world and has been the foundation for the design of safe and reliable chemical manufacturing processes in 8 decades. With our technical knowhow in hydrogen technologies, we are currently further developing and optimizing next gen blue and green technologies, thereby needing thermodynamic tools for a wide range of hydrogen-containing systems, over a wide range of conditions, and for different properties. We see in general a need for standardization and guidelines on how to perform the thermodynamic part of this type of new projects, and embrace all relevant efforts, especially when it comes to properties and fluid behavior related to safety issues. The existing status both in terms of experimental data and thermodynamic models will be discussed and evaluated.Finally, some scientific areas will be mentioned where we see much promise in the future and we believe they can contribute to the modeling of the new processes, from a broader perspective, going “beyond” thermodynamic analysis and allowing a more holistic assessment of new projects.

Enhanced photodegradation of 3-nitro-1, 2, 4-triazol-5-one by FeCuO bimetallic catalyst supported on mesoporous carbon nitride

3-Nitro-1,2,4-triazol-5-one (NTO) is one high energy and insensitive single explosive that has been applied in insensitive ammunition in recent years. However, the high deposition of NTO after detonation and the challenge of wasterwater treatment during its productive process are the key concerns of the environmental issue and safe manufacture. The catalytic performance of the traditional Fe-based catalysts for the decontaminating wastewater owing to the high stability of the triazole ring of NTO. To address this problem, FeCuO/mpg-C3N4 was prepared by depositing Fe-Cu oxides on mesoporous carbon nitride (mpg-C3N4) as the catalysts of photo Fenton process. After optimizing the metal ratio and screening the reaction condition, FeCuO/mpg-C3N4(5:5, 6%) exhibited the unprecedent k value of 0.10669 min−1 (96.4% degradation after 30 min) in the photo degradation of NTO (λ > 400 nm; 1000 mg/L FeCuO/mpg-C3N4; 40 mg/L NTO) and maintained high catalytic activity after 2 cycles (k1 =0.09491 min−1, k2 =0.08607 min−1). By characterizing thoroughly the catalysts, the synergetic effect of Fe-Cu bimetallic oxide and the contribution of the carbon nitride in the photo Fenton process have been evidenced, which presents an efficient, environmentally friendly, and cost-effective approach for treating NTO wastewater, offering a novel method and concept for addressing other challenging-to-degrade organic pollutant wastewaters.

Efficacy of Pectobacterium carotovorum subsp. carotovorum inactivation using ultraviolet C light-emitting diodes: Investigation of inactivation efficacy toward planktonic and biofilm cells on the stainless steel surfaces of cutting machines

The presence of Pectobacterium carotovorum subsp. carotovorum (P. carotovorum) in kimchi cabbage (Brassica rapa L. subsp. pekinensis) negatively influences kimchi quality. Accordingly, inactivation processes to effectively control spoilage caused by plant bacteria, including P. carotovorum, are crucial for extending the shelf life of kimchi. In this regard, ultraviolet C light-emitting diode (UVC-LED) technologies are increasingly attracting attention as non-thermal and non-contact sterilization technologies and are also considered as alternatives to chemical disinfectants. In this study, we investigated the efficacy of the inactivation of P. carotovorum planktonic and biofilm cells that cause cabbage soft rot disease using the UVC-LED treatment technology as a potential disinfection method for a safe kimchi manufacturing process. A biofilm was formed on the surface of a stainless-steel cutter knife using the recommended CDC biofilm reactor system and thereafter, exposed to a range of UVC-LED intensities. Our results indicated that P. carotovorum planktonic and biofilm cells to UVC-LED irradiation at 9.0 mJ/cm2 resulted in >5.0 and >2.0 log10 inactivation, respectively. Additionally, the P. carotovorum planktonic and biofilm cell inactivation kinetics fitted the non-linear reduction curve. The UVC-LED treatment was also found to be highly efficient in eliminating planktonic cells, showing consistency with the Weibull and Weibull tailing models for planktonic cells.

Exposure considerations in human safety assessment: Report from an EPAA Partners’ Forum

Understanding and estimating the exposure to a substance is one of the fundamental requirements for safe manufacture and use. Many approaches are taken to determine exposure to substances, mainly driven by potential use and regulatory need. There are many opportunities to improve and optimise the use of exposure information for chemical safety. The European Partnership for Alternative Approaches to Animal Testing (EPAA) therefore convened a Partners’ Forum (PF) to explore exposure considerations in human safety assessment of industrial products to agree key conclusions for the regulatory acceptance of exposure assessment approaches and priority areas for further research investment. The PF recognised the widescale use of exposure information across industrial sectors with the possibilities of creating synergies between different sectors. Further, the PF acknowledged that the EPAA could make a significant contribution to promote the use of exposure data in human safety assessment, with an aim to address specific regulatory needs. To achieve this, research needs, as well as synergies and areas for potential collaboration across sectors, were identified.

Application of Herbs and Dietary Supplements in ADHD Management.

Attention Deficit Hyperactivity Disorder is a neurodevelopmental disorder, which is characterised by a distinct clinical pattern of inattention, hyperactivity as well as impulsivity, which in turn interferes with the day-to-day activities of the affected individual. Although conventional allopathic medications have been found to provide symptomatic relief, they are accompanied by a plethora of side effects that overshadow and outweigh the potential therapeutic benefits. Hence, various alternative approaches in the management of Attention Deficit Hyperactivity Disorder (ADHD) are actively being investigated. Over the past few decades, numerous studies have been initiated and have delved into potential alternative strategies in the treatment and management of ADHD. The primary focus of this article is to discuss the etiology, pathophysiology coupled with a financial background as well as alternative strategies in the treatment and management of ADHD. A review of the literature on the clinical trialson alternative treatment approaches for ADHD showed that, plants and dietary supplements have beneficial effects on ADHD management. But in-depth studies still need to be conducted because the trials reported till now have a smaller sample size and need to be scaled up to get a broader understanding and knowledge of the potential impact of alternative forms of natural treatment on the patient population with ADHD. Also, the manufacturer of the alternative formulations needs to develop effective protocols and processes for the safe, effective, and robust manufacturing of such natural remedies, which fall in line with the expectation of the FDA to gain regulatory clearance for its manufacturing and sale, which can lead to better therapeutic outcomes in patients.

A preliminary study on the establishment of a cyst and cystic neoplasm tissue-mimicking model.

The present experimental models of cystic diseases are not adequate and require further investigation. In this study, a new way of producing a tissue-mimicking model of cysts and cystic neoplasms was evaluated. To simulate cysts and cystic neoplasms, ex vivo rabbit normal bladders and VX2-implanted tumor bladders were produced, fixed, and embedded in agarose gel. The samples were classified into four groups based on tumor features and the maximal transverse diameter of the rabbit bladder, which were assessed using computer tomography (CT) imaging and statistically analyzed. Statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) software. The t-test was used for analyzing enumeration data. Twenty-one rabbit bladders (21/24) were successfully removed and prepped for this experiment, comprising eleven normal bladders (11/24) and ten implanted with VX2 tumors (10/24). The gelling ingredient used to form the visualization and fixation matrix was agarose at a concentration of 4 g/200 mL. The temperature of the agarose solution was kept constant at 40-45°C, which is the optimal temperature range for ex vivo normal bladder and implanted VX2 tumor bladder insertion. The average time required to embed and fix the bladders in agarose gel was 45.0 ± 5.2 minutes per instance. The gel-fixing matrix's strength and light transmittance were enough for building the models. We created an experimental tissue-mimicking model of cysts and cystic neoplasms with stable physicochemical features, a safe manufacturing method, and high repeatability. These models may be used to assist with cystic lesion diagnosis and treatment techniques.