Development Of Advanced Products Research Articles

Multistimuli responsive microcapsules produced by the prilling/vibration technique for targeted colonic delivery of probiotics

This study aimed to microencapsulate the probiotic strain Lactiplantibacillus plantarum 4S6R (basonym Lactobacillus plantarum) in both microcapsules and microspheres by prilling/vibration technique. A specific polymeric mixture, selected for its responsiveness to parallel colonic stimuli, was individuated as a carrier of microparticles. Although the microspheres were consistent with some critical quality parameters, they showed a low encapsulation efficiency and were discarded. The microcapsules produced demonstrated high yields (97.52%) and encapsulation efficiencies (90.06%), with dimensional analysis and SEM studies confirming the desired size morphology and structure. The results of thermal stress tests indicate the ability of the microcapsules to protect the probiotic. Stability studies showed a significant advantage of the microcapsules over non-encapsulated probiotics, with greater stability over time. The release study under simulated gastrointestinal conditions demonstrated the ability of the microcapsules to protect the probiotics from gastric acid and bile salts, ensuring their viability. Examination in a simulated faecal medium revealed the ability of the microcapsules to release the bacteria into the colon, enhancing their beneficial impact on gut health. This research suggests that the selected mixture of reactive polymers holds promise for improving the survival and efficacy of probiotics in the gastrointestinal tract, paving the way for the development of advanced probiotic products.

Digitalization Of Document Management System In Medical Organizations: Theoretical Aspect

Introduction. Modern medical organizations, multifunctional medical centers, public and private medical institutions actively use digital technologies such as document management systems to optimize internal business processes and increase the efficiency. Proper document management and easy access improve the workflow. Thus, integration and development of advanced digital products allow medical organizations to ensure efficient time management which, in turn, reduces costs and saves time. The purpose of the study was to present theoretical aspects of digitalization of document management system in medical organizations as a modern organizational and managerial process that ensures the effectiveness of healthcare development. Materials and methods. Content analysis of scientific literature on the development and implementation of document management systems, transfer of documents to electronic version, introduction of digital technologies upon the specifics of medical organizations was used. Results. The study showed that document management systems currently run up document-based information lifecycle management. Their active implementation began in the 2000s, and it is expected that the market volume of document management systems will grow from 6.57 billion US dollars in 2023 to 12.94 billion US dollars by 2028, on average by 14.50% during the forecast period (2023-2028). Significant amounts of health data are collected manually using various internal IT-systems and numerous collections of documents, databases and forms. The introduction of document management systems allows healthcare actors to create electronic patient records, thereby minimizing the risk of documentation loss and increasing security. It is assumed that in the near future all the system will be based on digital solutions aimed at solving routine tasks such as document management, storage and use. These trends provide solutions to the problems that medical organizations may face and ensure effective strategies based on the digitalization of document management systems.

In situ measurement of austenite grain growth and recrystallization using laser ultrasonics

The development of next generation process models and advanced high-strength steel products for thin slab casting and direct rolling requires quantification of microstructure evolution during thermomechanical processing. Laser ultrasonics is a non-contact in-situ method to record grain growth, recrystallization and phase transformations in metals and alloys. Here, we will present an improved experimental design that facilitates a continuous microstructure measurement through the various stages of simulated hot rolling from reheating to runout table cooling using a Gleeble thermomechanical simulator equipped with a laser ultrasonics for metallurgy (LUMet) system. Austenite grain growth and static recrystallization after hot deformation are quantified based on attenuation of the ultrasound waves whereas austenite decomposition can be recorded with the changes in ultrasound velocity during the phase transformation. Further, the LUMet results for a microalloyed low carbon steel are validated with conventional techniques including optical and electron microscopy as well as double-hit tests. These experimental studies demonstrate the capabilities of laser ultrasonics in the identification of both normal and abnormal grain growth, non-recrystallization temperature, recrystallization, and austenite decomposition kinetics in a single test for a given processing path, as well as its potential for accelerated optimization of process control under industrial rolling conditions.

In vitro evaluation of the antiglycation and antioxidant potential of the dietary supplement L-citrulline

Diabetes mellitus (DM) represents a significant global public health concern. It is a metabolic condition characterized by abnormal glucose levels in the bloodstream, known as hyperglycemia. This condition arises due to irregular insulin secretion, defective insulin receptivity, or a combination of both factors. The primary contributors to diabetic complications are protein glycation and oxidative stress resulting from chronic hyperglycemia.
 The aim. The increasing incidence of diabetes mellitus has prompted a quest for a novel, cost-effective, and efficacious medication. The objective of the study generally intends to explore and investigate the antiglycation and antioxidant potential of the dietary supplement L-Citrulline
 Materials and methods. A two-reaction model system was carried out to study and monitor the inhibitory impact of the dietary supplement L-Citrulline against advanced glycation end products (AGEs) formation. This system involved the in vitro glucose bovine serum albumin (BSA-glucose assay) and methylglyoxal bovine serum albumin (BSA-MGO assay). The antioxidant activity of the supplement was assessed by measuring its capacity to chelate metal ions and scavenge reactive oxygen species. The iron chelating activity was evaluated through absorbance measurements, while fluorescence measurements were employed for the remaining assays.
 Results. According to the findings of the antiglycation assays, it was observed that the dietary supplement L-Citrulline demonstrated inhibitory properties against the development of advanced glycation end products (AGEs) in the BSA-Glucose model at a concentration of 100 ppm. The degree of inhibition with respect to glycation was ascertained to be 52.19 ± 0.39 % through observation. The BSA-MGO model has exhibited inhibitory properties with an observed activity of 49.64 ± 0.27 % at 100ppm concentration with respect to glycation. On the other hand, the supplement demonstrates antioxidant characteristics through the chelation of Fe ions, leading to a percentage difference in activity of 68.58 ± 0.45 % compared to the control at 100 ppm. The utilization of Glucolypotoxixity (GLT) media during the reactive oxygen species assay yielded a significant rise of 173.48 ± 9.37 % in the reactive species levels compared to the control, with statistical significance. The addition of 10 mM dietary supplement L-Citrulline resulted in a noteworthy reduction of 98.42 ± 5.04 % in the escalation. Therefore, it can be deduced that utilizing L-Citrulline as a dietary supplement exhibits potential for its therapeutic applications in eliminating reactive oxygen species (ROS) within skeletal muscle cells.
 Conclusion. The study results suggest that the dietary supplement L-Citrulline has demonstrated inhibitory capabilities against glycation at varying concentration levels. Furthermore, it was noted to exhibit significant efficacy in both sets of antioxidant tests. Therefore, the supplement exhibits potential in the treatment of diabetes mellitus

International Society for Cell & Gene Therapy Position Paper: Key considerations to support evidence-based cell and gene therapies and oppose marketing of unproven products

The field of regenerative medicine, including cellular immunotherapies, is on a remarkable growth trajectory. Dozens of cell-, tissue- and gene-based products have received marketing authorization worldwide while hundreds-to-thousands are either in preclinical development or under clinical investigation in phased clinical trials. However, the promise of regenerative therapies has also given rise to a global industry of direct-to-consumer offerings of prematurely commercialized cell and cell-based products with unknown safety and efficacy profiles. Since its inception, the International Society for Cell & Gene Therapy Committee on the Ethics of Cell and Gene Therapy has opposed the premature commercialization of unproven cell- and gene-based interventions and supported the development of evidence-based advanced therapy products. In the present Guide, targeted at International Society for Cell & Gene Therapy members, we analyze this industry, focusing in particular on distinctive features of unproven cell and cell-based products and the use of tokens of scientific legitimacy as persuasive marketing devices. We also provide an overview of reporting mechanisms for patients who believe they have been harmed by administration of unapproved and unproven products and suggest practical strategies to address the direct-to-consumer marketing of such products. Development of this Guide epitomizes our continued support for the ethical and rigorous development of cell and cell-based products with patient safety and therapeutic benefit as guiding principles.

A controlled forearm washing ex vivo method for assessing the impact of personal cleansing products on skin's acid mantle properties and antimicrobial defence against transient bacteria.

An important trend in the personal care industry involves the development of advanced personal cleaning products that not only provide skin mildness but support skin's acid mantle properties and skin's natural antimicrobial defence function. The objective of this study was to develop a controlled forearm washing ex vivo method for assessing the impact of personal cleansing products on skin's acid mantle properties and antimicrobial defence against transient bacteria. We developed a controlled forearm washing ex vivo method (ex vivo NET method) to compare the impact of two representative personal cleansing products on skin's acid mantle properties and antimicrobial defence against transient bacteria: one was a low-pH skin cleanser, and the other was high-pH soap cleanser. Skin pH was measured at baseline and 4 h after the product application. Concurrently, D-squame tape stripping procedure was followed to sample the stratum corneum surface layers. Then, two selected transient bacteria, Staphylococcus aureus and Escherichia coli, were inoculated onto the D-squame tapes and incubated under controlled conditions, respectively. The residual bacteria counts can provide an objective measure of skin's acid mantle properties against transient bacteria. Results from the ex vivo NET method were compared with the traditional in vivo cup-scrub RET method. The skin pH was significantly lower 4 h after washing the forearm with the low-pH cleanser versus the high-pH soap, consistent with literatures. Interestingly, the skin surface washed by the low-pH cleanser showed significantly higher hostility against representative transient bacteria as demonstrated by the lower counts of S. aureus by 1.09 log and E. coli by 0.6 log versus the high-pH soap based on the ex vivo NET method. Results from the ex vivo NET method were further supported by the traditional in vivo RET method which also showed the skin washed by the low-pH cleanser had significantly lower counts of S. aureus and E. coli versus the high-pH soap. The skin's acid mantle properties and antimicrobial defence can be directly impacted by the personal cleansing products. The low-pH skin cleanser works better than the high-pH soap for supporting skin's acid mantle properties and antimicrobial defence against transient bacteria. Results from the ex vivo NET method are consistent with the in vivo RET method. It is important that the ex vivo NET method offers many advantages since it is quicker to run with higher throughput and has better safety without the constraint of inoculating harmful microorganisms onto the human subjects.

Advanced Hydrogels Combined with Silver and Gold Nanoparticles against Antimicrobial Resistance.

The development of multidrug-resistant (MDR) microorganisms has increased dramatically in the last decade as a natural consequence of the misuse and overuse of antimicrobials. The World Health Organization (WHO) recognizes that this is one of the top ten global public health threats facing humanity today, demanding urgent multisectoral action. The UK government foresees that bacterial antimicrobial resistance (AMR) could kill 10 million people per year by 2050 worldwide. In this sense, metallic nanoparticles (NPs) have emerged as promising alternatives due to their outstanding antibacterial and antibiofilm properties. The efficient delivery of the NPs is also a matter of concern, and recent studies have demonstrated that hydrogels present an excellent ability to perform this task. The porous hydrogel structure with a high-water retention capability is a convenient host for the incorporation of the metallic nanoparticles, providing an efficient path to deliver the NPs properly reducing bacterial infections caused by MDR pathogenic microorganisms. This article reviews the most recent investigations on the characteristics, applications, advantages, and limitations of hydrogels combined with metallic NPs for treating MDR bacteria. The mechanisms of action and the antibiofilm activity of the NPs incorporated into hydrogels are also described. Finally, this contribution intends to fill some gaps in nanomedicine and serve as a guide for the development of advanced medical products.

Chromatographic Purification of Viral Vectors for Gene Therapy Applications.

Chromatography has been a mainstay in the downstream processing and purification of biopharmaceutical medicines. Until now, this has largely involved the purification of protein products such as recombinant enzymes and monoclonal antibodies using large-scale column chromatography methods. The development of advanced therapeutic medicinal products (ATMP) is heralding in a new era of therapeutics for a range of indications. These new therapeutics use diverse substances ranging from live stem cell preparations to fragments of nucleic acid enclosed in a viral delivery system. With these new technologies come new challenges in their purification. In this chapter, the challenges faced in producing and purifying viral vectors capable of delivering life-altering gene therapy to the patient will be discussed. Current methods of chromatography capable of adaptation to meet these new challenges and advancements that may be needed to increase the purification capabilities for these new products will also be discussed.

Characterization of Formacell Lignin Derived from Black Liquor as a Potential Green Additive for Advanced Biocomposites

Black liquor is obtained as a by-product of the pulping process, which is used to convert biomass into pulp by removing lignin, hemicelluloses and other extractives from wood to free cellulose fibers. Lignin represents a major constituent in black liquor, with quantities varying from 20% to 30%, of which a very low share is used for manufacturing value-added products, while the rest is mainly burned for energy purposes, thus underestimating its great potential as a raw material. Therefore, it is essential to establish new isolation and extraction methods to increase lignin valorization in the development of bio-based chemicals. The aim of this research work was to determine the effect of KOH or ethanol concentration as an isolation agent on lignin yields and the chemical characteristics of lignin isolated from formacell black liquor of oil palm empty fruit bunch (OPEFB). Isolation of lignin was carried out using KOH with various concentrations ranging from 5% to 15% (w/v). Ethanol was also used to precipitate lignin from black liquor at concentrations varying from 5% to 30% (v/v). The results obtained showed that the addition of KOH solution at 12.5% and 15% concentrations resulted in better lignin yield and chemical properties of lignin, i.e., pH values of 3.86 and 4.27, lignin yield of 12.78% and 14.95%, methoxyl content of 11.33% and 10.13%, and lignin equivalent weights of 476.25 and 427.03, respectively. Due to its phenolic structure and rich functional groups that are favorable for modifications, lignin has the potential to be used as a green additive in the development of advanced biocomposite products in various applications to replace current fossil fuel-based material, ranging from fillers, fire retardants, formaldehyde scavengers, carbon fibers, aerogels, and wood adhesives.

Patients’ views on using human embryonic stem cells to treat Parkinson’s disease: an interview study

BackgroundHuman embryonic stem cells (hESC) as a source for the development of advanced therapy medicinal products are considered for treatment of Parkinson’s disease (PD). Research has shown promising results and opened an avenue of great importance for patients who currently lack a disease modifying therapy. The use of hESC has given rise to moral concerns and been the focus of often heated debates on the moral status of human embryos. Approval for marketing is still pending.ObjectiveTo Investigate the perspectives and concerns of patients with PD, patients being the directly concerned stakeholders in the ethical discussion.MethodsQualitative semi-structured interviews related to this new therapy in seventeen patients from two Swedish cities.ResultsThe participants expressed various interests related to the use of human embryos for development of medicinal therapies; however, overall, they were positive towards the use of hESC for treatment of PD. It was deemed important that the donating woman or couple made the choice to donate embryos voluntarily. Furthermore, there were concerns that the industry does not always prioritise the patient over profit; thus, transparency was seen as important.

A dataset of temperature, humidity, and liquid water path retrievals from a network of ground-based microwave radiometers dedicated to fog investigation

The database presented in this study has been acquired during the SOuth west FOGs 3D (SOFOG3D) experiment for processes study. This international campaign led by Météo-France during the winter 2019–2020 aimed at deploying a unique network of both in situ and remote sensing measurements in order to document spatial and temporal variabilities of fog events. To support this scientific objective but also to conduct first data assimilation experiments within the French convective scale model AROME, an un-precedented network of 8 ground-based microwave radiometers (MWR) has been deployed in 7 different locations known to be prone to fog occurrences. The database gives access to vertical profiles of temperature and humidity (both absolute and relative) from the surface up to 10 km altitude as well as integrated water vapor and liquid water path estimates. The retrieved profiles offer a very large database that can be exploited for several scientific purposes: fog process studies at specific location, documentation on the variability of fog properties at the regional scale, better understanding of the atmospheric boundary layer (ABL) height and dynamics during wintertime conditions, development of nowcasting products dedicated to fog alerts, data assimilation experiments to improve fog forecasts, development of synergetical advanced products, and evaluation of new model configurations with advanced parameterization or resolutions.

Research Progress of Food-Grade High Internal Phase Pickering Emulsions and Their Application in 3D Printing.

High internal phase Pickering emulsion (HIPPE) is a type of emulsion stabilized by solid particles irreversibly adsorbed on an interfacial film, and the volume fraction of the dispersed phase (Φ) is larger than the maximum packing volume fraction (Φmax). Proteins, polysaccharides, and their composite particles can be used as good particle stabilizers. The contact angle can most intuitively demonstrate the hydrophilicity and hydrophobicity of the particles and also determines the type of emulsions (O/W or W/O type). Particles’ three-phase contact angles can be adjusted to about 90° by compounding or modification, which is more conducive to emulsion stability. As a shear thinning pseudoplastic fluid, HIPPE can be extruded smoothly through 3D printer nozzles, and its high storage modulus can support the structure of printed products. There is huge potential for future applications in 3D printing of food. This work reviewed the biomacromolecules that can be used to stabilize food-grade HIPPE, the stabilization mechanism of the emulsions, and the research progress of food 3D printing to provide a reference for the development of advanced food products based on HIPPE.

Inside the UK’s brave new world of ATMP regulatory innovation

Jacqueline Barry is the Chief Clinical Officer, responsible for Clinical Translation and Delivery activities and an Executive Director of the Cell and Gene Therapy Catapult. She has extensive experience in the development of advanced therapy medicinal products and leads a multi-disciplinary team of Nonclinical, Regulatory, Clinical Operations and Programme Management specialists. She also leads the coordination of the UK Advanced Therapy Treatment Centre Network and is a Director of the Global Alliance for iPSC Therapies. She feels passionately about making advanced therapies available for patients and works closely with the MHRA and the NHS on the development of the ecosystems to support the adoption of these therapies. Prior her time at Cell and Gene Therapy Catapult, Jacqueline worked at the Scottish National Blood Transfusion Service where amongst other activities she designed the regulatory strategy for the Cellular Therapies for the Blood Transfusion Service and acted as Qualified Person for their release. She has a PhD from the University of Aberdeen and did post-doctoral research in neurophysiology at the University of Edinburgh.

Room temperature quenching and partitioning (RT-Q&P) processed steel with chemically heterogeneous initial microstructure

Microstructure heterogeneity has been regarded as being detrimental in obtaining reliable mechanical performance of steels. However, in the present study, we demonstrated that a proactive control of microstructure heterogeneity could deliver unprecedented tensile properties that was hardly achieved by using chemically homogeneous initial microstructure. The heterogeneity of Mn distribution generated by utilizing its solubility difference between ferrite, austenite and cementite at intercritical annealing, promoted the retention of austenite in the final microstructure subjected to the room quenching and partitioning process. The enhancement of fraction as well as the stability of austenite contributed to the simultaneous improvement of tensile strength and ductility which have been regarded as mutually exclusive properties. Furthermore, even in steel with lean Mn composition, the room temperature quenching and partitioning process combined with the chemically heterogeneous initial microstructure presented tensile properties comparable to those expected in steels with much higher Mn content, which exhibited the potential of heterogeneity-driven microstructure control for the development of advanced steel products.

굴양식업의 구조변화에 따른 재편 방향

The purpose of this paper is to investigate the characteristics of structural changes in oyster farming, and to explore the current issues and direction of restructuring. The oyster farming industry has grown rapidly since the 1970s, but production has plummeted since the late 1980s and stagnated until the 1990s. Since then, production has recovered, but since 2010, production has been increasing and decreasing year by year. At present, the immediate problem in the oyster farming industry is that the volatility of oyster production has stagnated or become serious. Second, it is becoming difficult to secure a stable labor force. Third, oyster consumption is shrinking due to changes in social structure and food consumption trends. Fourth, oyster safety is constantly occurring. Fifth, oyster farming is highly dependent on exports, but export countries and export items are limited. In order to improve the competitiveness of the oyster farming industry, the first step is to eliminate the overcrowding of oyster farming facilities, secure artificial seedlings, improve aquaculture methods, and switch to other aquaculture varieties. Second, we will discover new demand targets through high-quality product development and product promotion. Third, in order to ensure the hygiene and safety of oysters, we will establish a hygiene and safety management system from the harvesting stage to the distribution and consumption stage. Fourth, we should explore new markets through overseas market research and consumption trends related to oysters, development of advanced processing and health functional products.

Automatic Programmable Bioreactor with pH Monitoring System for Tissue Engineering Application.

Tissue engineering technology has been advanced and applied to various applications in the past few years. The presence of a bioreactor is one key factor to the successful development of advanced tissue engineering products. In this work, we developed a programmable bioreactor with a controlling program that allowed each component to be automatically operated. Moreover, we developed a new pH sensor for non-contact and real-time pH monitoring. We demonstrated that the prototype bioreactor could facilitate automatic cell culture of L929 cells. It showed that the cell viability was greater than 80% and cell proliferation was enhanced compared to that of the control obtained by a conventional cell culture procedure. This result suggests the possibility of a system that could be potentially useful for medical and industrial applications, including cultured meat, drug testing, etc.

Revisiting Methodologies for In Vitro Preparations of Advanced Glycation End Products.

Chronic elevation of sugar and oxidative stress generally results in development of advanced glycation end products (AGEs) in diabetic individuals. Accumulation of AGEs in an individual can give rise to the activation of several pathways that will ultimately lead to various complications. Such AGEs can also be prepared in an in vitro environment. For an in vitro preparation of advanced glycation end products (AGEs), proteins, lipids, or nucleic acids are generally required to be incubated with reducing sugars at a physiological temperature or higher depending upon the protocol optimized for its preparation. Certain other factors are also optimized and added to the buffer to hasten its preparation or alter the properties of prepared AGEs. Through this review, we intend to highlight the various studies related to the experimental procedures for the preparation of different types of AGEs. In addition, we present the comparative study of methodologies optimized for the preparation of AGEs.

A New Configuration for Redox Flow Battery

During our previous development of vanadium flow battery products and advanced Fe-Cr flow battery products, we found that a major disadvantage of all flow battery systems is the massive energy loss from electrolyte pumping, mixing and the shunt current-related energy loss along the electrolyte transferring pipelines, especially for low power applications. With this understanding, we developed a new flow battery configuration and operation concept: a flow battery with periodical replacement of energy storage media (i.e., electrolyte) inside the stack. Figure 3 gives a schematic illustration of this battery system. The electrolyte is not continuously flowing through the stacks. The electrolyte inside the stack is periodically replaced by a new batch of charged or discharged electrolyte, depending on the need. A reversible pump or two pumps can be used to achieve this operation requirement. Many batches of charged or discharged electrolyte are stored in a serially connected containers, eliminating the need for solution mixing in the system. This configuration also improves the charge and discharge efficiency. Without continuously electrolyte flowing along the pipelines, the electrolyte solutions can be separated by multiple insulation spacers, eliminating the shunt current loss. Smooth power absorption and output can be realized through an Energy Management System by coordinating operation of multiple units or by working together with another battery product, such as a lithium battery or a lead acid battery.

Retinal Pigment Epithelium Transplantation in a Non-human Primate Model for Degenerative Retinal Diseases

Retinal pigment epithelial (RPE) transplantation holds great promise for the treatment of inherited and acquired retinal degenerative diseases. These conditions include retinitis pigmentosa (RP) and advanced forms of age-related macular degeneration (AMD), such as geographic atrophy (GA). Together, these disorders represent a significant proportion of currently untreatable blindness globally. These unmet medical needs have generated heightened academic interest in developing methods of RPE replacement. Among the animal models commonly utilized for preclinical testing of therapeutics, the non-human primate (NHP) is the only animal model that has a macula. As it shares this anatomical similarity with the human eye, the NHP eye is an important and appropriate preclinical animal model for the development of advanced therapy medicinal products (ATMPs) such as RPE cell therapy. This manuscript describes a method for the submacular transplantation of an RPE monolayer, cultured on a polyethylene terephthalate (PET) cell carrier, underneath the macula onto a surgically created RPE wound in immunosuppressed NHPs. The fovea-the central avascular portion of the macula-is the site of the greatest mechanical weakness during the transplantation. Foveal trauma will occur if the initial subretinal fluid injection generates an excessive force on the retina. Hence, slow injection under perfluorocarbon liquid (PFCL) vitreous tamponade is recommended with a dual-bore subretinal injection cannula at low intraocular pressure (IOP) settings to create a retinal bleb. Pretreatment with an intravitreal plasminogen injection to release parafoveal RPE-photoreceptor adhesions is also advised. These combined strategies can reduce the likelihood of foveal tears when compared to conventional techniques. The NHP is a key animal model in the preclinical phase of RPE cell therapy development. This protocol addresses the technical challenges associated with the delivery of RPE cellular therapy in the NHP eye.

Retinal Pigment Epithelium Transplantation in a Non-human Primate Model for Degenerative Retinal Diseases.

Retinal pigment epithelial (RPE) transplantation holds great promise for the treatment of inherited and acquired retinal degenerative diseases. These conditions include retinitis pigmentosa (RP) and advanced forms of age-related macular degeneration (AMD), such as geographic atrophy (GA). Together, these disorders represent a significant proportion of currently untreatable blindness globally. These unmet medical needs have generated heightened academic interest in developing methods of RPE replacement. Among the animal models commonly utilized for preclinical testing of therapeutics, the non-human primate (NHP) is the only animal model that has a macula. As it shares this anatomical similarity with the human eye, the NHP eye is an important and appropriate preclinical animal model for the development of advanced therapy medicinal products (ATMPs) such as RPE cell therapy. This manuscript describes a method for the submacular transplantation of an RPE monolayer, cultured on a polyethylene terephthalate (PET) cell carrier, underneath the macula onto a surgically created RPE wound in immunosuppressed NHPs. The fovea-the central avascular portion of the macula-is the site of the greatest mechanical weakness during the transplantation. Foveal trauma will occur if the initial subretinal fluid injection generates an excessive force on the retina. Hence, slow injection under perfluorocarbon liquid (PFCL) vitreous tamponade is recommended with a dual-bore subretinal injection cannula at low intraocular pressure (IOP) settings to create a retinal bleb. Pretreatment with an intravitreal plasminogen injection to release parafoveal RPE-photoreceptor adhesions is also advised. These combined strategies can reduce the likelihood of foveal tears when compared to conventional techniques. The NHP is a key animal model in the preclinical phase of RPE cell therapy development. This protocol addresses the technical challenges associated with the delivery of RPE cellular therapy in the NHP eye.