Aspects Of Products Research Articles

Assessing the effects of bladder decellularization protocols on extracellular matrix (ECM) structure, mechanics, and biology

Acellular matrices have historically been applied as biologic scaffolds in surgery, wound care, and tissue engineering, albeit with inconsistent outcomes. One aspect that varies widely between products is the selection of decellularization protocol, yet few studies assess comparative effectiveness of these protocols in preserving mechanics, and protein content. This study characterizes bladder acellular matrix (BAM) using two different detergent and enzymatic protocols, evaluating effects on nuclei and DNA removal (≥90%), structure, tensile properties, and maintenance of extracellular matrix proteins. Porcine bladders were decellularized with 0.5% Sodium Dodecyl Sulfate (SDS) or 0.25% Trypsin-hypotonic-Triton X-100 hypertonic (TT)-based agitation protocols, followed by DNase/RNase agents. Characterization of BAM included decellularization efficacy (DAPI, DNA quantification), structure (histology and scanning electron microscopy), tensile testing (Instron 345C-1 mechanical tester), and protein presence and diversity (mass spectrometry). SDS and TT data was directly compared to the same native bladder using two-tailed paired t-tests. Native, TT, and SDS cohorts for tensile testing were compared using one-way ANOVA; Tukey's post-hoc tests for among group differences. Effective nuclei removal was achieved by SDS- and TT-based protocols. However, target DNA removal was achieved with SDS but not TT. SDS more effectively maintained qualitative tissue architecture compared to TT. The tensile modulus of the TT cohort increased, and stretchability decreased after decellularization in both SDS and TT. UTS was unaffected by either protocol. Higher overall diversity and quantity of core matrisome and matrisome-associated proteins was maintained in the SDS vs TT cohort post-decellularization. The results indicated that detergent selection affects multiple aspects of the resultant BAM biologic product. In the selected protocols, SDS was superior to TT efficacy, and maintenance of gross tissue architecture as well as maintenance of ECM proteins. Decellularization increased scaffold resistance to deformation in both cohorts. Future studies applying biologic scaffolds must consider the processing method and agents used to ensure that materials selected are optimized for characteristics that will facilitate effective translational use.

Experience on Utilization of Novel Modeling & Simulation Approaches in Generic Product Development

Modeling and simulation approaches such as Physiologically Based Pharmacokinetic (PBPK) and Physiologically Based Biopharmaceutics Modeling (PBBM) are gaining importance due to their impact to transform drug development paradigm. Development of such modeling approaches include integration of drug substance, drug product and physiological aspects followed by validation against clinical data. In this manuscript, we have highlighted utility of PBPK and PBBM in generic product development using case examples. An application where PBBM was utilized to obtain biowaivers and dissolution safe space was portrayed. Utility of such modeling approaches in obtaining fed bioequivalence studies was discussed with case example. Impact of gender evaluation on bioequivalence study outcome using PBPK approach was highlighted with a case example. Evaluation of safety aspects of extended release formulation with help of modeling approach was discussed with practical example. In the last case study, understanding the impact of critical bioavailability attributes with help of PBBM was indicated. Further, future direction in terms of sharing best practices across academia, industry and regulatory was highlighted. Overall, this manuscript summarizes experience on utilization of modeling and simulation approaches in generic product development with an aim to have more affordable and quality medicines to the patients.

Tingkat Kepuasan Konsumen Pada Bungkoez Cafe Kota Manado

This study aims to analyze the level of customer satisfaction at Bungkoez Cafe Manado City seen from the aspects of product, price, promotion, place and service. This research was conducted for 4 months, from October 2023 to February 2024, at Bungkoez Cafe Manado City. The data collection method was collected using primary data obtained through direct observation in the field, by conducting observations and interviews with cafe owners, employees and consumers, as well as giving questionnaires to consumers to fill out. Secondary data is obtained from internet sites, books, articles, research journals and various other documents related to the research. The sampling method for Bungkoez Cafe consumers used accidental sampling method, the number of samples obtained was 45 consumers based on a time limit of 5 days consisting of 3 working days and 2 holidays with respondents around 7-9 people per day. The analysis method used in this research is descriptive analysis, analyzing the answers obtained from the questionnaire, calculating the Likert Scale method, and analyzing the characteristics of each research variable using the index formula in each aspect of the marketing mix. The results showed that the results of the index number of customer satisfaction levels at Bungkoez Cafe Manado City in terms of product, price, location, promotion and service were at 80.86%, this shows that overall the manager of Bungkoez Cafe Manado City has reached the level of customer satisfaction even though there are still several indicators that need attention.

Strategi Pemasaran Dodol Salak UD Mandiri Di Desa Pangu Satu Kecamatan Ratahan Timur Kabupaten Minahasa Tenggara

This study aims to identify the marketing strategy of salak dodol UD MANDIRI in Pangu Satu Village, Ratahan Timur Subdistrict. This research was conducted for 2 months from September to October 2023, starting from the preparation period until the preparation of the report. This research was conducted in Pangu Satu Village, East Ratahan District, Southeast Minahasa Regency. The data used in this study are primary data taken directly from the UD MANDIRI salak dodol production site obtained through interview activities using tools in the form of questionnaires, and observation activities. While secondary data is obtained through literature or references related to the research. The sampling method in this study is based on anyone who is encountered by chance (accidental sampling), and is willing to become a respondent then used as a sample. Sampling was carried out for 2 weeks using 15 respondents. The data analysis used in this study is descriptive analysis using a Likert scale. The results showed that the respondents' assessment of the product aspect was 96.29 percent with a good category, the price aspect was 89.33 percent with a good category, the place aspect was 65.1 percent with a fairly good category, the promotion aspect was 49.62 percent with a poor category, and the service aspect was 86.6 percent with a fairly good category. Based on the results and discussions that have been carried out, it can be concluded that UD MANDIRI's salak dodol marketing strategy using 4P 1S is in the good enough category.

Spatiotemporal Characteristics and Driving Factors of Ecosystem Regulation Services Value at the Plot Scale

The value of ecosystem regulation services (ERSV) is a crucial aspect of gross ecosystem product (GEP). Understanding and mastering the spatiotemporal evolution characteristics and driving factors of ERSV is essential for the efficient management of regional ecosystems. This study proposes an ERSV accounting model at the plot scale and uses the barycentric analysis method, the optimal parameters-based geographical detector model (OPGD), and the constraint line extraction method to analyze the spatiotemporal evolution characteristics, main driving factors, and constraint rules of ERSV in Yunyang District, Hubei Province in 2016, 2018, 2020, and 2021. The results show that (1) In the temporal dimension, the overall ERSV of the district increased by CNY 1.664 billion from 2016 to 2021, with an increase rate of 3.68%. The contribution values of climate regulation function and water retention function to ERSV was significant. (2) In the spatial dimension, the ERSV was high in the north and south and low in the middle, with high-value areas mainly located in woodland and wetland areas. The center of gravity of the ERSV increase shifted to the southwest by 12,455.42 m, while the center of gravity of the reduction shifted to the southwest by 3582.79 m from 2016 to 2021. (3) The interaction of any two driving factors had greater explanatory power for the spatial differentiation of ERSV than that of a single driving factor, and all of them showed nonlinear or double factor enhancement characteristics. The human active index (HAI) and construction land proportion (CLP) were the leading anthropogenic factors, while the land surface temperature (LST) and NDVI were the leading natural factors. (4) The ERSV could maintain a high and stable value output when the HAI was less than 0.3, CLP was less than 15%, LST was between 18 and 22 °C, and NDVI was greater than 0.5. These results can guide the practices of ecology, production, and life in Yunyang District and contribute to the high quality and sustainable development of the regional ecology and economy.

UTILIZATION OF MUSLIM PUBLIC SPACES AS A MEDIUM FOR DISCUSSION OF HALAL FOOD PRODUCTS IN INDONESIA

Public space is formed from the development of communication and information ztechnology involving internet users in cyberspace. Public space is utilized as a forum for discussion related to halal food products in Indonesia by the Muslim community. This discussion related to Muslim public space uses a case study method to examine phenomena that exist on Instagram social media. The discussion results show that mass media can be used effectively to exchange information between individuals included in the cyber community to discuss various aspects of halal food products in Indonesia. The role of public space as a forum for discussion of halal food products can add insight and improve the quality of consumers in choosing halal food products.

Selection and Optimization of Carbon-Reinforced Polyether Ether Ketone Process Parameters in 3D Printing-A Rotating Component Application.

The selection of process parameters is crucial in 3D printing for product manufacturing. These parameters govern the operation of production machinery and influence the mechanical properties, production time, and other aspects of the final product. The optimal process parameter settings vary depending on the product and printing application. This study identifies the most suitable cluster of process parameters for producing rotating components, specifically impellers, using carbon-reinforced Polyether Ether Ketone (CF-PEEK) thermoplastic filament. A mathematical programming technique using a rating method was employed to select the appropriate process parameters. The research concludes that an infill density of 70%, a layer height of 0.15 mm, a printing speed of 60 mm/s, a platform temperature of 195 °C, an extruder temperature of 445 °C, and an extruder travel speed of 95 mm/s are optimal process parameters for manufacturing rotating components using carbon-reinforced PEEK material.

Evaluation of Achievement Development Management of Bhayangkara Precision Football Club

Evaluation of Bhayangkara Presisi Football Club Achievement Development Management. Thesis. Yogyakarta: Masters Program, Faculty of Sports and Health Sciences, Yogyakarta State University, 2024. The aim of this research is to find out the evaluation of the Bhayangkara Presisi Football Club's achievement development program, examining it from the context, input, Process and Product (CIPP) aspects as well as finding out whether the achievement development program that has been running at the Bhayangkara Presisi Football Club has been managed optimally. This research is a type of quantitative and qualitative research with the CIPP evaluation model. The sampling technique used purposive sampling technique to obtain a sample of three program administrators, three coaches and six players. Evaluation uses quantitative and qualitative approaches. Data collection uses research instruments in the form of observation, questionnaires, interviews and documentation. The results of the research, namely, Context evaluation of Bhayangkara Presisi FC's achievement coaching management, amounted to 2.91, which is in the good category. Based on the background indicators of the coaching program, it is 3.09 in the good category, the coaching program objectives are 2.60 in the good category, and the coaching program is 3.03 in the good category. The evaluation input for Bhayangkara Presisi FC's achievement coaching management, amounting to 2.75, is in the good category. Based on the human resources indicator, it is 3.07 in the good category, the trainer program is 3.05 in the good category, funding is 2.66 in the good category, facilities and infrastructure is 2.66 in the good category, and parental support is 2.29 in the poor category. Bhayangkara Presisi FC's achievement management evaluation process, amounting to 2.83, is in the good category. Based on the program implementation indicator, it is 3.06 in the good category, and coordination is 2.83 in the good category. Bhayangkara Presisi FC's performance management management evaluation product, amounting to 3.27, is in the good category. Based on the achievement indicator of 3.33 in the good category and welfare of 3.20 in the good category.

Analisis Strategi Pemasaran Dalam Meningkatkan Daya Saing Pada Restoran Makanan Cepat Saji Rocket Chicken Tlogosari Raya

This research was conducted at Rocket Chicken Tlogosari Semarang. This study aims to determine (1) What kind of marketing strategy Rocket Chicken Tlogosari is doing in the midst of increasing business competition (2) The marketing mix carried out by Rocket Chicken Tlogosari in increasing competitiveness (3) Why Rocket Chicken is still able to maintain its business until now. The strategy carried out by Rocket Chicken Tlogosari is to use marketing strategies (4P) namely Product, Price, Place and Promotion. This research uses a case study method, with data collection through indepth interview techniques, direct observation and documentation. To test the credibility of the data using triangulation of data sources and triangulation of data collection techniques. The research data sources in in-depth interviews are participants who have a position or authority in the object of research, namely as many as 5 (five) participants. The results of this research show that in the application of marketing strategies (4P) from the product aspect, Rocket Chicken Tlogosari always applies the predetermined SOP so that it has quality products, the price that Rocket Chicken Tlogosari has is very affordable for consumers, the place or location that Rocket Chicken Tlogosari has is very strategic and the promotion carried out by Rocket Chicken Tlogosari through social media. In this study, several problems were found that Rocket Chicken Tlogosari experienced, such as the lack of menu innovation offered and less than optimal promotion on social media. The solution to the problems experienced by Rocket Chicken Tlogosari is that it is necessary to innovate the menu so that it can attract consumer interest and in terms of promotion Rocket Chicken Tlogosari needs to have an Instagram social media account with higher traffic than other social media, this aims to intensify promotions so that consumers know more about the latest products and promos from Rocket Chicken Tlogosari

Virtue marketing: Trends in health-, eco-, and cause-oriented claims on the packaging of new alcohol products in Australia between 2013 and 2023.

Some claims on alcohol labels highlight virtuous aspects of brands or products, including in health-, eco-, and cause-oriented domains (including charity partnerships, or ethical or humanitarian certifications). This virtue marketing may create a 'halo' whereby consumers generalise from specific attributes to a more favourable overall appraisal of the product, brand, or even alcohol or the alcohol industry in general. This study aims to describe the prevalence of and trends over time in virtue marketing on the packaging of new alcohol (including lower and zero alcohol) products on the Australian market. Records of N=4,024 new alcohol products released in Australia between 2013 and 2023 were extracted from Mintel Global New Products Database. Health-, eco-, and cause-oriented claims on packaging were summarised across product types and time, and co-occurrence between claims was assessed. Virtue marketing appeared on 36.5% of new alcohol products, of which health-oriented claims were most common (32.5%), followed by eco- (6.3%) and cause-oriented claims (2.0%). The prevalence of each claim category and virtue marketing overall significantly increased over time (each p<.001) and varied by product type. New alcohol products displayed as many as eight different types of claims and all claims tended to co-occur with at least two others. Virtue marketing is prevalent on new alcohol products in Australia and has recently increased. While product packaging can provide useful consumer information, health-, eco-, and cause-oriented claims may exploit consumers' motivation to make healthy, sustainable, and socially responsible choices despite alcohol being detrimental in these areas.

Considerations on the authenticity and nutritional aspects of green coffee products consumed in Brazil

Several benefits have been attributed to the consumption of green coffee, in the form of capsules or teas, mainly due to its high content of phenolic acids, which allegedly show antioxidant, antimutagenic, and anticarcinogenic activities in vitro. Chlorogenic acid is the phenolic compound present in greater proportion in coffee and the consumption of green coffee extract has been associated with health and loss of weight. However, beyond these bioactive compounds with a healthy appeal, other compounds which can have deleterious health effects should be considered in the consumption of these extracts, such as the presence of contaminants (ochratoxin A and its producing fungi), phytates, and tannins, which exhibit anti-nutritional characteristics. In that sense, this manuscript seeks to assess the composition of commercial green coffee extracts, analyzing their authenticity, nutritional and anti-nutritional aspects, to provide technical information for a qualified discussion about the effective healthiness of the consumption of commercial green coffee extracts. Nine samples of green coffee food supplements were selected and a product was prepared to serve as a standard. It was possible to identify coffee DNA in six of the commercial samples of food supplements. The products had antioxidant activity between 33 and 2408 µmol of Trolox/g. It was possible to identify chlorogenic acid in all samples with concentrations ranging from 0.023 - 20 mg / g of coffee. Six samples presented positive values for ochratoxin A, despite being within the limits of the coffee roasted legislation, there is a certain concern about the safety of these supplements.

Additive manufacturing of high entropy shape memory alloy with outstanding properties through multi-remelting in-situ alloying

With the introduction of a fourth dimension, time, into 3D printing, 4D printing enables unparalleled control over spatial and temporal aspects of 3D products in respond to external stimuli. However, the recovery performance of the 4D printed shape memory alloys still falls short of expectations. In this study, a novel high entropy shape memory alloy (HESMEA) was developed using in-situ alloying laser powder bed fusion (LPBF) by introducing a moderate amount of silicon (10 % atomic percent) to a metastable Fe50Mn30Co10Cr10 HEA matrix. Multi-remelting strategy was employed to improve the chemical homogeneity of the printed HESMA with enhanced diffusion occurring during the remelt scan. The 3-remelting HESMA exhibited a near uniform chemical distribution, showcasing an excellent combination of shape memory performance and mechanical properties, with an admirable recoverable strain of 5.2 % and a high yield strength of about 500 MPa. It was found that the high recovery strain was attributed to low stacking fault energy of the HESMA matrix, while combination of refined grain size, high density dislocations and nano precipitation contributed to high yield strength of the HESMA. Overall, the solid solution matrix and hierarchical strengthening characteristics of the newly developed HESMA makes it particularly suitable for 4D printing with excellent comprehensive properties.

Marketing Strategy Analysis using AHP-SWOT Method to Increase Sales Volume

PT. X is a food manufacturer located in Gresik. Currently, the company, which was established in 2018, is facing an issue, namely a decline in sales figures leading to a significant decrease in profit. Therefore, this research will analyze the existing marketing strategies to propose new strategies to increase sales. The method used in this study is AHP-SWOT. AHP is used to determine the weighting of each aspect, while SWOT is used to determine proposed strategies. Based on the research conducted, it was found that the aspect with the highest weight, at 43.35% as determined by AHP, is the product aspect, which includes product quality, variety, and display. Based on the SWOT results, it was found that PT. X is in quadrant 2, indicating that the company still has strengths but faces various threats. Proposed strategies include increasing product quality with halal-labeled products and expanding promotion reach by utilizing social media campaigns and marketplace.

Towards a formal ontology of engineering functions, behaviours, and capabilities

In both applied ontology and engineering, functionality is a well-researched topic, since it is through teleological causal reasoning that domain experts build mental models of engineering systems, giving birth to functions. These mental models are important throughout the whole lifecycle of any product, being used from the design phase up to diagnosis activities. Though a vast amount of work to model functions has already been carried out, the literature has not settled on a shared and well-defined approach due to the variety of concepts involved and the modeling tasks that functional descriptions should satisfy. The work in this paper posits the basis and makes some crucial steps towards a rich ontological description of functions and related concepts, such as behaviour, capability, and capacity. A conceptual analysis of such notions is carried out using the top-level ontology DOLCE as a framework, and the ensuing logical theory is formally described in first-order logic and OWL, showing how ontological concepts can model major aspects of engineering products in applications. In particular, it is shown how functions can be distinguished from the implementation methods to realize them, how one can differentiate between capabilities and capacities of a product, and how these are related to engineering functions.

The Evaluation of the Implementation of the Independent Curriculum E-Report at Ngasinan Elementary School, Semarang Regency

To facilitate teachers in administrative matters related to reporting students' learning outcomes, an E-Report is used as a reporting tool. This research aimed to analyze or evaluate the use of the Independent Curriculum E-Report at Ngasinan Elementary School in Semarang Regency. The research utilized the CIPP evaluation model (Context, Input, Process, Product). Interviews, documentary studies, and observations were employed to collect data. Data collection, data reduction, data presentation, and drawing conclusions were the data analysis techniques used in this research. The research findings on the contextual aspect align with the Curriculum Implementation Guidelines, which emphasize the periodic delivery of student reports through E-Reports. The input aspect in the areas of planning, human resources, financing, and infrastructure is generally in accordance, but there is a need for improvement in certain areas. The process aspect includes pre-implementation procedures, implementation, management of infrastructure, human resources, and financing in accordance with the guidelines. The product aspect involves the improvement of human resource quality, accurate and up-to-date information, accountability, efficiency, convenience, and reports in both print and digital formats. The driving factors include collaboration, awareness, convenience, motivation, transparency, infrastructure, financing, and efficiency. The inhibiting factors include a lack of infrastructure, internet connectivity, skills, and systems.

Management Evaluation in the Achievement Development Program of Football Sport Branch at FC UNY Academy

This research aims to assess the management's evaluation of the FC UNY Academy football achievement development program using the Context, Input, Process, and Product (CIPP) framework. Additionally, it seeks to determine if the ongoing achievement development program at the FC UNY Academy is being effectively managed. This qualitative research employs the CIPP evaluation model, with a purposive sampling technique to select three program administrators for study. Data collection involves interviews and documentation. The research findings indicate that the management evaluation of the FC UNY Academy achievement development program met adequate criteria across all aspects, signifying a moderate level of performance. However, the management's effectiveness in optimizing the program remains suboptimal. Specifically, the context aspect meets sufficient criteria, the input meets adequate criteria, the process meets good criteria, and the product meets adequate criteria. Key considerations are identified in the context, input, and product aspects. Recommendations for administrators include: Context aspect: Increase the number of administrators to enhance management performance. Input aspect: Enhance promotional activities and counselling during player recruitment to showcase player potential effectively. Process aspect: Optimize processes for better outcomes. Product aspect: Despite having tier 2 players, coaches should maximize player potential to achieve championship results in tournaments.

Research on the Influence of Strategic Adjustment on Enterprise Performance from The Perspective of Mixed Reform of State-owned Enterprises

In order to effectively solve the problems of low operation efficiency and rigid management system of state-owned enterprises, governments at all levels have actively implemented and practiced mixed ownership reform since 2016, trying to promote industrial optimization and upgrading through mixed reform and stimulate the internal development potential of state-owned enterprises. With the continuous development of the economy and society, the state adopted the three-year Action Plan for SoE Reform (2020-2022) in June 2020, giving guiding opinions and new requirements for further deepening the reform of soes. In this context, to help has not yet been mixed change of state-owned enterprises to better understand the concrete implementation process, Shanxi Fen Wine, for example, starting from the mixed change for, the enterprise mixed change in-depth after expanding brand depth, integrated marketing resources, strengthen scientific research innovation, innovation product strategy, optimize the governance structure of five strategic adjustment direction, and the strategic adjustment of influence on enterprise performance. Finally, it draws enlightenment from the three aspects of path selection of mixed reform, advantage utilization of mixed reform and control of strategic direction, which provides reference for the strategic adjustment of mixed reform of state-owned enterprises in the industry. The research found that Shanxi Fen Wine combined with the advantages of mixed reform and made strategic adjustments around the five aspects of brand, marketing, scientific research, product and governance, which had a positive and positive impact on the financial performance of enterprises.

Does digitalization help green consumption? Empirical test based on the perspective of supply and demand of green products

Green consumption (GC) is an unavoidable choice for mitigating environmental pressures, achieving the “double carbon goal”, and promoting the development of a low-carbon, green society as a whole. With the rapid advancement of digitization (Digi), artificial intelligence, big data, and other associated digital technologies have become powerful driving forces for GC from both the supply and demand perspectives. Therefore, a spatial Durbin model (SDM) was utilized to investigate the local and spatial spillover impacts of Digi on GC based on panel data from 2011 to 2020 from 30 Chinese provinces. It was found that: (1) Digi can influence both the supply and demand aspects of green products, establishing a positive correlation with local GC. It also exerted a favorable incentive effect on GC in neighboring provinces through spatial connections and spatial spillover, within the framework of the imitation mechanism. Several robustness tests revealed that the effects remained significant. (2) the enhanced market mechanisms and a favorable competitive environment offered by the high-level market, in addition to the subsidy and incentive mechanisms within the government's Green Consumption Policy (GCP), were instrumental in fostering the development of GC. Consequently, the government's role in “promotion” and the market's role in “pull” had a regulating effect on the impact of Digi on GC. (3) heterogeneity analysis illustrated that Digi had a more significant promoting effect on GC in the comprehensive big data pilot and large-scale industrial digitization areas. Based on this, we suggest that the state increase investment in Digi to provide a foundation for the research and development of green digital technologies. Additionally, the state should promote the construction and improvement of green consumer markets and formulate more incentive or penalty systems conducive to promoting GC. The research results also provide a theoretical basis for the direct and dynamic effects of Digi, as well as inspiration for promoting GC and green sustainable development.

Ranking products through online opinions: A text analysis and regret theory-based approach

With the development of e-shopping, a list of similar products can be found with a large volume of valuable customer reviews online. However, it is generally difficult to compare various aspects of similar products effectively by understanding all relevant online opinions. To help consumers, in this study, how products are ranked according to online reviews is investigated. Firstly, an SC-LDA (Seed Constraint-Latent Dirichlet Allocation) model, which is an extension of the classical topic model LDA (Latent Dirichlet Allocation), is proposed to extract product features. The must-link and cannot-link seed constraints are invited to estimate the probability expansion/reduction value. They help to affect the topic allocation by additional constraints in Gibbs sampling for a higher accuracy on feature extraction. Secondly, an improved convolutional memory neural network model is devised to analyze the sentiment polarity. It takes the advantages of CNN (convolutional neural network) and Bi-LSTM (bidirectional Long Short-Term Memory) and performs dynamic pooling in CNN to prevent the loss of important features. Besides, the concept of group satisfaction degree is introduced, which makes products be compared according to the Regret Theory. It ranks products without a commonly applied reference point and take consumer psychology into considerations. Finally, in the case study, an illustrative example is presented to evaluate the proposed framework. Categories of experiments show that the proposed framework provides consumers with effective purchase suggestions. Code metadataPermanent link to reproducible Capsule: https://doi.org/10.24433/CO.6445683.v1 and https://doi.org/10.24433/CO.2658577.v1.

EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells.

Great advances have been made in the knowledge of development and regulatory approval of medicinal product containing genetically modified cells. Although a guideline has been available in the EU since 2012, the current updated version provides a useful guide to developers and professionals involved in the regulatory process of these medicines. This article presents the main issues communicated in that guidance, the regulators' insights and a commentary from the academic developers' point of view.