Quality Control Specifications Research Articles

Automation of simplified two-step radiolabeling via ditosylate synthon for 18F-labeled radiotracers using AllinOne module

Direct fluorination of a tosylate or mesylate precursor has been a wide-spread and reliable way for radio-fluorination. This approach can be difficult to achieve when the precursor cannot be easily obtained or is chemically unstable. A possible alternative method is to radiolabel ethylene ditosylate or 1,3-propanediol di-p-tosylate to form a radiofluorinated synthon. Here we present the automation of a simplified and reliable approach for the two-step fluorination using [18F]FP-TMP, an analog of antibacterial agent trimethoprim. We demonstrate the feasibility of purifying the fluorinated synthon via filtration, and one final HPLC purification on a commercially available Trasis AllinOne module. The overall reaction time for the two-step reaction is around 90 min andthe decay-corrected yield for more than fifty preparations of [18F]FP-TMP is 22 ± 5 % with high radiochemical purity (≥ 90 %) and specific activities (147 ± 107 GBq/μmol). All batches passed pre-established quality control specifications, demonstrating the utility of using this method in tracer syntheses that meet good manufacturing practice (GMP) requirement. This method can be adopted to the syntheses of other radiotracers, such as [18F]FE-TMP, (+)-[18F]F-PHNO and [18F]FFMZ.

Sustainable Building Construction Materials in the United Arab Emirates: A Review

The construction industry, a major player in economic development, is facing increased pressure to address sustainability concerns amidst rapid population growth and urbanization. With global projections indicating a significant rise in building demand by 2050, sustainability has emerged as a crucial focus area and paradigm shift to enhance environmental friendliness, quality, and project outcomes. The UAE, renowned for its vibrant construction industry, offers a unique context for examining the integration of sustainable practices. The use of sustainable construction practices is growing in the UAE, where the built environment plays a key role in economic growth and environmental stewardship. The United Arab Emirates (UAE) aims to foster long-term sustainability while enhancing the standard of living for current and future generations by integrating social, environmental, and economic aspects within construction projects, while also reevaluating conventional sustainable development frameworks and embracing a triple bottom line approach. This research was conducted to explore sustainable construction material usage and evaluation in the United Arab Emirates. The literature was reviewed for sustainable building construction materials across the UAE in the SCOPUS index from 2014 to 2024, as well as the regional regulations concerning the subject. This study evaluated the increasing trend of sustainable construction material research works, as well as the sound regional parameters of sustainable construction materials implemented across the country. Through an exploration of the significance of sustainable construction materials, this research underscores the multifaceted benefits of locally sourced, recyclable, and renewable materials in reducing environmental impacts, fostering economic and social well-being, and improving overall project performance and project management practices. The construction sector’s role in economic development and its substantial environmental impact are discussed in alignment with sustainable construction materials, sustainable construction practices, and the need to enhance environmental sustainability and create healthier built environments. In the realm of sustainable construction materials, project management knowledge areas encompass a range of factors. These include the properties of materials sourced regionally; the incorporation of recycled content; considerations for indoor air quality, energy, and water efficiency parameters; and how these properties relate to project scopes, scheduling constraints, and challenges. Additionally, the availability of resources and competency levels, quality control standards, specifications, communication strategies, and stakeholder involvement play crucial roles. It is important to assess both the positive and negative risks associated with these elements across construction projects.

Abstract 5018: Evaluation of whole blood fractionation conditions for optimal liquid biopsy NGS applications

Abstract “For research use only. Not for diagnostic procedures.” Introduction: Liquid biopsy is a non-invasive alternative to tissue biopsies for cancer profiling using cell-free total nucleic acids (cfTNA; including cell free DNA (cfDNA) and cell free RNA (cfRNA)), the biological analytes derived from tumor cells floating in blood. However, it is crucial to optimize the whole blood fractionation workflows, since limited access to a suitable centrifuge at blood collection sites poses a challenge to this critical fractionation step, causing delays in processing the blood, leading to decreased sensitivity of variant detection and increased occurrence of false positives. Current study shows a systematic comparison of the effects of 8 different blood fractionation conditions for spin speeds, temperatures and duration on the levels of cfTNA derived from K2-EDTA-derived blood from multiple healthy and non-small cell lung cancer (NSCLC) donors, using next generation sequencing (NGS). Methods: CfTNA from K2-EDTA derived plasma was isolated using the MagMAXTM Cell-Free Total Nucleic Acid kit and the Genexus™ Cell free total nucleic acid kit, utilizing the KingFisher TM Flex and GenexusTMpurification systems. Yield and integrity of cfTNA isolated was evaluated by Qubit™, Agilent Tapestation and quantitative real time PCR (qRT-PCR). Furthermore, the impact of these test conditions on quality control specifications of DNA and RNA was assessed by performing sequencing on an Ion TorrentTM GenexusTM sequencing instrument using the AmpliSeqTM HD target amplification assay, that reports sequence variations in DNA for 42 cancer related genes and RNA in 7 cancer related genes. Results: Results showed comparable performance for all the 8 blood fractionation conditions tested, for yield and cfDNA profiles compared to control condition, indicating that there is no significant impact of these conditions on either yield or integrity of the cfDNA isolated. In addition, NGS data also showed that on target reads and median molecular coverage for DNA are comparable for all the conditions tested. However, sequencing data demonstrated that one test condition showed significantly better performance for RNA quality control specifications in terms of RNA mapped reads and molecular coverage for process controls used in the assay, compared to all other conditions tested. Conclusion: Data suggests that one of the whole blood fractionation conditions tested impact the cfRNA recovery from plasma without negatively affecting the yield, and integrity of isolated cfDNA and shows increased sensitivity for RNA process controls in NGS. Citation Format: MADHU JASTI, Sergio Hernandez, Nick Siepert, Lokesh Kodandaramaswamy, Thilanka Jayaweera, Jeoffrey Schageman, Angie Cheng, Susanne Lopez, Miao Der Chen. Evaluation of whole blood fractionation conditions for optimal liquid biopsy NGS applications [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 5018.

Fully automated production of [11C]PiB for clinical use on Trasis-AllinOne synthesizer module

Pittsburgh compound B ([11C]PiB) was the first broadly applied radiotracer with specificity for amyloid-β (Aβ) peptide aggregates in the brain and has since been established as the gold standard for positron emission tomography (PET) employed for clinical in vivo imaging of Aβ plaques, used for imaging applications of Alzheimer's disease (AD), related dementia, and other tauopathies. The use of [11C]PiB for routine PET studies is dependent on the production capabilities of each radiochemistry laboratory, subsequently a continuous effort is made to develop suitable and sustainable methods on a variety of auto synthesis platforms.Here we report a fully automated, multi-step radio synthesis, purification, and reformulation of [11C]PiB for PET imaging using the Trasis AllinOne synthesis unit, a commonly used commercial radiochemistry module. We performed three validation runs to evaluate the reproducibility and to verify that the acceptable criteria were met for the release of clinical-grade [11C]PiB using a Trasis AllinOne auto radiosynthesis unit. Solid phase supported radiolabeling was performed through the capture of precursor (6-OH-BTA-0) on a C18 solid phase extraction (SPE) cartridge and subsequent flushing of gaseous [11C]Methyl triflate(MeOTf) through the Sep-Pak for carbon-11 (11C) N-methylation. Starting with 92.5 GBq [11C]CO2, [11C]PiB synthesis was completed in approximately 25 min after cyclotron end of bombardment with an injectable dose >7.0 GBq at end of the synthesis. The radiopharmaceutical product met all quality control criteria and specifications for use in human studies.

Development of an Analytical Workflow to Support the Establishment of Monographs in African Pharmacopoeias - Combretum mucronatum Leaves as Example.

Herbal medicines are invaluable in African medicine, but quality and safety are not documented in many cases. Besides controlled farming, validated quality control methods are needed to ensure identity, purity, and content. Analytical specifications within modern monographs are needed for consistent batch quality. Combretum mucronatum leaves are widely used in West Africa, but state-of-the-art quality control methods and specifications are non-existent. The aim of the following study was the development of ICH-validated chromatographic protocols for identity, purity, content assay, and analytical specifications for consideration into pharmacopoeial monographs. UPLC-ESI-Q-TOF-MS/MS was used for untargeted phytochemical information on composition. Optimisation of extraction was based on phytochemical profiling. HPTLC was used for differentiation of C. mucronatum from other Combretum species and UPLC for simultaneous determination of 7 marker compounds. C. mucronatum batch analyses (n = 49) investigated the influence of harvest time and geographical origin. Pesticides screening from a 349-compound panel were carried out. 30 compounds, identified by LC-MS, were used for characterization of the plant material. Orietin, isoorientin, vitexin and isovitexin were used as specific marker compounds for qualitative and quantitative HPTLC purposes, while UPLC quantified additionally epicatechin, procyanidins B2 and C1. Influence of harvest time and geographic origin on the content of marker compounds was observed. Differences in the metabolite profiles of C. mucronatum compared to related Combretum species were established for quality control purposes. Contamination with high amoounts of chlorpyrifos, and folpet (sum of folpet and phtalimide, expressed as folpet) were also observed.The study provides analytical protocols, analytical specifications and a drafted monograph for consideration for African pharmacopoeias, and reveals potential challenges in the quality of C. mucronatum.

Study on Quality Control of Forensic Toxicology Identification

Forensic toxicology evaluation is an important content of judicial appraisal, the appraisal result directly affects the quality and the accuracy of case detection and justice, but the current domestic forensic toxicology evaluation in terms of quality control, is still in use the old rules and regulations, and alcohol appraisal, despite its relatively mature and perfect system, but also there are some problems in terms of technology and institution. Alcohol judge professionalism is uneven, these reasons led to the forensic identification of quality control, the low efficiency of poison, for this reason, this paper proposes perfecting the forensic identification of alcohol quality control specification, enhance the level of forensic alcohol identification technology and strengthening construction personnel appraisal of the three ways to improve the level of the quality control of forensic toxicology evaluation, We should give full play to the practical role of forensic toxicology identification and promote the construction of socialist rule of law.

Human mesenchymal stem cells.

Mesenchymal stem cells (MSCs) have attracted great interest for cell therapy and tissue regeneration due to their self‐renewal capacity, multipotency and potent immunomodulatory effects on immune cells. However, heterogeneity of MSCs has become a prominent obstacle to limit their translation into practice, as cells from different tissue sources or each individual have great differences in their transcriptomic signatures, differentiation potential and biological functions. Therefore, there is an urgent need for consensus standard for the quality control and technical specifications of MSCs. ‘Human Mesenchymal Stem Cells’ is the latest set of guidelines on hMSC in China, jointly drafted and agreed upon by experts from the Chinese Society for Stem Cell Research. This standard specifies the technical requirements, test methods, test regulations, instructions for use, labelling requirements, packaging requirements, storage requirements, transportation requirements and waste disposal requirements for hMSC, which is applicable to the quality control for hMSC. It was originally released by the China Society for Cell Biology on 9 January 2021. We hope that publication of these guidelines will facilitate institutional establishment, acceptance and execution of proper protocols, and accelerate the international standardization of hMSC for clinical development and therapeutic applications.

Traditional medicinal knowledge in Lancang-Mekong River:a case study in Lancang Lahu autonomous county

Lancang Lahu autonomous county, where the Lancang-Mekong River flows by, was selected as the case site to investigate the traditional medicinal knowledge(TMK). A comparison of TMK between Lancang county and other places in the Lancang-Mekong sub-region was conducted. Research on TMK has been seldom reported although there are abundant medicinal resources in this sub-region. The key informant interview and other methods have been adopted in the field surveys in the past six years. The investigation revealed that there was rich TMK and various herbal medicine resources in Lancang county. A total of 220 folk prescriptions have been collected, which were normally simple with easy processing methods and usages, and most raw materials were freshly used. As for medicinal plants, 121 species in 67 families have been documented. Other findings included that TMK in Lancang county was remained at the level of medication based on experience only. The processing methods of herbal medicines were simple and the bioactive ingredients were not clear. Without text and cultural support for self-teaching, coupled with conservative inheritance, it resulted in massive losses of TMK. The folk doctors have accumulated their factions based on self-study or ancestral experience. There was different treatment experience among folk doctors, but the safety and effectiveness should be paid attention to. The folk doctors used various herbal medicines, but there was a lack of standards or specifications for quality control. Given the problems existing in inheritance and development, conservation strategies were proposed in the present study.

Brick of the Historical Heritage: Comparative Analysis of The Thermal Conductivity, Density and Moisture

In the renovation of historic buildings, the facades deserve special attention because, in general, it is where the property’s value and heritage lies. Additionally, they have a fundamental impact in the energetic efficiency of buildings. When you want to achieve an efficient building, the facades must comply with certain construction standards, generally difficult to achieve in renovations, especially in facades built with exposed brick, not altering their external appearance is a sine qua non condition. Against this background, in order to carry out optimal interventions in the thermal behavior of a brick wall, it is essential to have an exhaustive knowledge of the characteristics and values that influence thermal conductivity. To do so, calculations and simulations are carried out using the density and porosity parameters that are published in the different documents and regulations. However, these values are not reliable because they refer to the materials currently manufactured, and therefore, they are not valid when working with centenary materials that have been produced without quality control or precise technical specifications. On the other hand, the values provided by the regulations refer to the material in the dry state. It has not been considered that bricks, and especially those manufactured manually, due to their intrinsic conditions, are capable of absorbing large amounts of water, and therefore, of significantly varying its thermal conductivity. This feature is extrapolated to brickwork facades, where water can rise from the ground and penetrate from the rain. Thus, it is necessary that in the thermal conductivity study its hygrothermal behavior is taken into consideration. Against this background, this article presents the results of the tests carried out on specimens of various bricks from different traditional bricks factories and manufacturing processes and with an approximate age of about 100 years, to show that the old bricks have very different density, porosity and thermal conductivity values from the current ones. In addition, these values vary greatly depending on the moisture they contain, and also, the manufacturing system they had. Likewise, it is clear that the bricks of the facades of historic buildings, even if they are contemporaries, have different characteristics among them, showing different thermal behavior.

Correlation of Geometrical Specifications for Flexible Quality Control in the Manufacturing of Plastic Products

Correlation of Geometrical Specifications for Flexible Quality Control in the Manufacturing of Plastic Products

Comment on “Spatial distribution of microplastic concentration around landfill sites and its potential risk on groundwater”

This paper discusses some critical weak points and mistakes identified in the original paper. The authors disregarded the importance of field blanks, sampling equipment, and well specifications for proper quality assurance and control. Beneficial field practices guarantee highly reliable results of laboratory analysis for microplastics. In addition, polymer type (chemical composition) and shape (form) are different classification criteria, but the authors mixed these in their description. The distribution and transport of microplastics should be properly understood, along with a knowledge of groundwater flow conditions, such as flow direction and velocity, in the study area.

Annotation and quality control specifications for fundus color photograph

Annotation and quality control specifications for fundus color photograph

Nanocellulose characterization challenges

Despite the extraordinary properties of nanocellulose (NC), as confirmed through two decades of exhaustive research, addressing an array of potential applications, the NC market is still far from reaching its full potential. Among the main causes is the lack of process-adapted measuring tools capable of characterizing NC, at acceptable speed and reliability, to meet the industrial demands in a cost-effective way. Therefore, reliable characterization methodologies of NC and new standards are of paramount importance in ensuring reproducible research results and quality control specifications for present and future NC products and applications. Furthermore, the successful industrial use of NC products depends on critical parameters that are still being identified and studied. This review paper aims to identify some of the current drawbacks and limitations in NC characterization that hinder their commercial deployment. Moreover, important challenges related to characterization and new opportunities for future research in this field are addressed.

Process validation, current good manufacturing practice production, dosimetry, and toxicity studies of the carbonic anhydrase IX imaging agent [111 In]In-XYIMSR-01 for phase I regulatory approval.

[111 In]In-XYIMSR-01 is a promising single-photon emission computed tomography (SPECT) imaging agent for identification of tumors that overexpress carbonic anhydrase IX. To translate [111 In]In-XYIMSR-01 to phase I trials, we performed animal toxicity and dosimetry studies, determined the maximum dose for human use, and completed the chemistry, manufacturing, and controls component of a standard regulatory application. The production process, quality control testing, stability studies, and specifications for sterile drug product release were based on United States Pharmacopeia chapters <823> and <825>, FDA 21 CFR Part 212. Toxicity was evaluated by using nonradioactive [113/115 In]In-XYIMSR-01 according to 21 CFR Part 58 guidelines. Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM) was used to calculate the maximum single dose for human studies. Three process validation runs at starting radioactivities of ~800 MBq were completed with a minimum concentration of 407 MBq/ml and radiochemical purity of ≥99% at the end of synthesis. A single intravenous dose of 55 μg/ml of [113/115 In]In-XYIMSR-01 was well tolerated in male and female Sprague-Dawley rats. The calculated maximum single dose for human injection from dosimetry studies was 390.35 MBq of [111 In]In-XYIMSR-01. We have completed toxicity and dosimetry studies as well as validated a manufacturing process to test [111 In]In-XYIMSR-01 in a phase I clinical trial.

城市生态观测:质量控制对象、体系和规范编制

城市生态系统长期观测是开展城市生态安全评价和制定人居环境健康管理政策的基础。为了确保城市生态观测数据的准确性和科学性，通过辨识城市生态观测质量控制的概念，基于"人机料法环"理论构建了城市生态观测质量控制体系，结合城市生态观测质量控制相关规范的编制与实施现状，探讨了城市生态观测质量控制规范的编制技术。结果表明：（1）城市生态观测质量控制是面向城市生态观测内容（要素、空间格局、功能、服务），为保证生态观测全过程质量要求、提高生态观测结果的准确性而实施的质量控制活动和措施。（2）城市生态观测质量控制体系可从对象和过程这两个维度进行界定：对象维度方面，包括"人"-人员、"机"-仪器设备、"料"-数据、"法"-文件和"环"-观测过程5个方面；过程维度方面，涵盖城市生态观测全过程，包括城市生态观测前期准备工作、观测过程中以及观测后的数据录入、审核与评价等环节的质量控制措施。（3）我国已发布的生态观测相关技术标准中，发布的时间越晚，质量控制内容越完整，目前生态观测相关标准共102则，仅38则明确提出了质量控制具体要求。（4）《城市生态观测质量控制规范》编制需包含质量体系和质量控制措施两项技术内容，主要包括前引、正文和附录三个章节，对生态观测全过程质量保证和质量控制技术进行规定。;Long-term urban ecosystem observation is the basis for urban ecological safety evaluation and habitat health management policy formulation. In order to ensure the accuracy and scientificity of urban ecological observation data, this research first established an urban ecological observation quality control system based on the theory of Human-Machine-Material-Method-Environment by identifying the concept of urban ecological observation quality control, and discussed the compilation technology of urban ecological observation quality control specification by combining the current situation of preparation and implementation of urban ecological observation quality control specification. The results show that: (1) Quality control of urban ecological observation are the quality control activities and measures implemented for the content of urban ecological observation (elements, spatial patterns, functions, and services), to ensure the quality requirements of the whole process of ecological observation and improve the accuracy of ecological observation results. (2) The quality control system of urban ecological observation can be defined in two dimensions: object and process. The object dimension includes five aspects: human-personnel, machine-instruments and equipment, material-data, method- policy documents and environment- observation process; The process dimension covers the entire process of urban ecological observation, including the quality control measures in the pre-preparation work of urban ecological observation, data entry, review and evaluation during the observation process and after the observation. The quality control of the observation process is the main body of the quality control system. Different quality control measures should be developed according to different observation methods (sampling observation, positioning observation, socio-economic survey, and remote sensing observation) to achieve total quality management. (3) A total of 102 technical standards related to ecological observation have been published in China, only 38 of which clearly put forward specific requirements for quality control. Compared with local standards, ecological observations in national standards and industry standards involve more quality control content, and the quality control system is more complete. In 2005, the Marine Standard took the lead in issuing relevant standards for the content of ecological observation, and there is still a lack of standards for the quality control of ecological observations in urban ecosystems. (4) The compilation of Criterion on Quality Control of Urban Ecological Observation needs to contain two technical contents of quality system and quality control measures, mainly including three chapters, namely, the introduction, the main text, and the appendix, which provide for the quality assurance and quality control technologies for the whole process of ecological observation.

Radiosynthesis and quality control testing of the tau imaging positron emission tomography tracer [18 F]PM-PBB3 for clinical applications.

Recently, we produced 11 C-labeled 2-((1E,3E)-4-(6-(methylamino)pyridin-3-yl)buta-1,3-dienyl)benzo[d]thiazol-6-ol ([11 C]PBB3) as a clinically useful positron emission tomography (PET) tracer for in vivo imaging of tau pathologies in the human brain. To overcome the limitations (i.e., rapid in vivo metabolism and short half-life) of [11 C]PBB3, we further synthesized 18 F-labeled 1-fluoro-3-((2-((1E,3E)-4-(6-(methylamino)pyridine-3-yl)buta-1,3-dien-1-yl)benzo[d]thiazol-6-yl)oxy)propan-2-ol ([18 F]PM-PBB3). [18 F]PM-PBB3 is also a useful tau PET tracer for imaging tau pathologies. In this study, we developed a routine radiosynthesis and quality control testing of [18 F]PM-PBB3 for clinical applications. [18 F]PM-PBB3 was synthesized by direct 18 F-fluorination of the tosylated derivative, followed by removal of the protecting group. [18 F]PM-PBB3 was obtained with sufficient radioactivity (25 ± 6.0% of the nondecay-corrected radiochemical yield at the end of synthesis, EOS), radiochemical purity (98 ± 0.6%), and molar activity (350 ± 94 GBq/μmol at EOS; n = 53). Moreover, [18 F]PM-PBB3 consistently retained >95% of radiochemical purity for 60 min without undergoing photoisomerization using a new UV-cutoff light (yellow light) fixed in the hot cell to monitor the synthesis. All the results of the quality control testing for the [18 F]PM-PBB3 injection complied with our in-house quality control and quality assurance specifications. We have accomplished >200 production runs of [18 F]PM-PBB3 in our facility for various research purposes.

Abstract 2302: Methylation profiling of circulating tumor DNA for the detection of ovarian cancer

Abstract Introduction: Ovarian cancer (OC), often diagnosed at an advanced stage, lacks effective screening strategy. It is the most lethal gynecological cancer, with a 5-year survival ranging from 35-50% depending on the subtype. A clear correlation between stage and survival has been demonstrated; therefore, early detection represents the best hope for mortality reduction. This study interrogates the potential of ctDNA methylation status as an early diagnostic marker for OC. Methods: Panel Design: Public data sets such as TCGA and GEO databases (tumor=4,014, normal=352) and in-house generated functional methylome (5.5 million CpG sites, 50X) sequencing data (n=561) were used to profile methylation alterations in 12 common cancer types. The panel covers 225,369 CpG sites, spanning ~3.5Mb of human genome. Deep targeted bisulfite sequencing (ELSA-seq) was performed on plasma samples of 126 Chinese ovarian cancer patients, 59 patients with benign ovarian diseases, including but not limited to endometrial cyst, ovarian cyst and serous cystadenoma and 49 age-matched asymptomatic females to interrogate their methylation statuses with an average sequencing depth of 1,000x. The plasma samples were collected and processed from two centers independently, and randomly assigned into the training (n=123) or validation group (n=113) at 1:1 ratio. Samples that failed quality control specifications were removed from the downstream analysis and the diagnostic information was not disclosed for the validation group until all analyses were completed. Results: First, ovarian tissues samples from 22 OC (FIGO stage II-III) patients, 11 ovarian benign diseases patients and 11 healthy donors were profiled to derive markers that can differentiate the 3 groups. In this study, 45,753 OC-specific differentially methylated CpG sites/loci (DMLs) were selected using modified wald-test with an adjusted p-value &amp;lt;0.05 and fold-change&amp;gt;2, and subsequently grouped into 3,160 differentially methylated blocks (DMBs) based on the co-methylation levels and genomic distances of adjacent CpG sites. Blood samples from 63 patients with OC (4 stage I, 6 stage II and 53 stage III), 33 patients with benign ovarian disease and 27 healthy individuals were obtained to train the diagnostic classification model using a support vector machine (SVM)-based machine learning classifier. Subsequently, iterated 5-fold cross-validation were performed to gain a robust estimation of model performance, achieving a specificity of 91% for benign ovarian diseases and sensitivity of 25%, 50% and 87% for stage I, II and III OC, respectively at a specificity of 93% and area under curve (AUC) of 91.3%. The model was subsequently validated in a hold-out cohort, consisting of 22 healthy individuals, 26 patients with benign ovarian disease and 63 stage I-III OC patients with comparable clinical characteristics as the patients in the training cohort. The model yielded a specificity of 93% for benign disease and a sensitivity of 84% for OC at a specificity of 96% in the validation cohort, suggesting its robustness. Conclusion: Our findings demonstrated the potential of ctDNA methylation profiling, which can effectively distinguish ovarian cancer, benign diseases and healthy, to serve as a diagnostic tool in ovarian cancer early detection. The general concept can be further extended to other types of cancer diagnostics. Citation Format: Ning Li, Yu Zhang, Xin Zhu, Zhenjing Zhang, Jiayue Xu, Bingsi Li, Han Han-Zhang, Fujun Qiu, Shuai Fang, Hao Liu, Zhihong Zhang. Methylation profiling of circulating tumor DNA for the detection of ovarian cancer [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 2302.

Model-Based Tools for Pharmaceutical Manufacturing Processes

Active pharmaceutical ingredients (APIs) are highly valuable, highly sensitive products resulting from production processes with strict quality control specifications and regulations that are required for the safety of patients [...]

A model for determining the value of patient satisfaction in healthcare

Purpose The purpose of this paper is to find determinants of the effectiveness of the business improvement processes that create value for services offered to patients in healthcare industries. The words patients and customers are used interchangeably throughout without any distinction. The features that distinguish medical services of different types and their inter-related factors are examined. The aim is to come up with a model of value vs cost that can help healthcare managers examine and use this exercise as an example of improvement micro-projects to help reduce cost and eliminate the patient’s dissatisfaction gaps. Design/methodology/approach The list of factors or attributes influencing the creation of value of a given medical process or a single procedure is described. The factors in the value creation are examined that will help in the categories for the risk analysis to determine the value-added benefits for the patient outcome. The cost analysis is approached from two angles to include: the cost of the service, and the costs of poor quality of service. Findings The model describes the value for the patient satisfaction depending on the quality level or grade of the treatment or procedures used and the cost factor. The analysis is done at several levels with special reference to case examples. A search for various analogous models in similar service providing situation used in business process management of other process types is highlighted and discussed. Originality/value The model is an interesting generic illustration for considering value vs cost in all patient care strategies. It enables the position of various medical procedures that can be applied to the same disease in order to keep the variations as minimum as possible within the quality control specification limits. The importance in different aspects of check-points or hold points for inspection is also discussed.

Automatic Selection Tool of Quality Control Specifications for Off-site Construction Manufacturing Products: A BIM-based Ontology Model Approach

Construction manufacturing specifications play an important role in assessing quality requirements on a construction project. However, working with these specifications can be overly complicated and error prone to the large amount of regulations and codes that need to be considered and their inter-dependencies. In building information modelling (BIM), the model is a digital representation of a complex construction product and contains precise product information data. The data is currently embedded into the model as properties for parametric building objects that are exchangeable among project operators. Some effort has been previously done to enhance the BIM model to obtain construction-oriented data and linking information that is crucial to manufacturing and quality control and assurance with BIM modelling still remains a challenge. This study proposes an extension to the current BIM-based product-oriented ontology model to include manufacturing processes and inspection, and quality control specifications. By automatically identifying which specifications are applicable to certain products and to extract the requirements imposed, this approach can support and enable automatic decision making in quality inspection and control tasks, which solely depend on information and knowledge from construction specifications. This approach is tested and validated using a light-gauge steel frame wall under Canadian construction standards and regulations.