Manufacturer's Specifications Research Articles

Rancang Bangun Pengisian Tegangan Baterai Handphone (HP) Metoda Buck Konverter DC-DC Tipe FC75

Mobile phone (HP) battery manufacturing specifications have a charging current capacity maximum parameter CAh(maks.) = 800 mAh and maximum voltage Vbat(max.) = 3.7 volts dc reduces to 2.02 volts dc requires recharging. In this research HP battery voltage was recharged using the FC75 dc-dc buck converter method, starting from a voltage of Vbat(initial) = 2.02 volts until the final battery voltage was charged at Vbat(final) = 3.713 volts. The HP battery charge voltage parameter Vch comes from the output voltage of the FC75 dc-dc buck converter the parameter Vo(conv.) is expressed as Vo(conv.) = Vch. The purpose of using the FC75 dc-dc buck converter is to electronically convert the lower Vo(conv.) charger voltage (buck) to the larger Vi(conv.) input voltage to control the HP battery charger output power equal to the input power. The results of the research on controlling the output power of the HP battery charger of Po(conv.) = Pi(conv.) = 0.579 watts, there was an increase in the final charger voltage Vokonv.(final) along with the increase in the final HP battery voltage Vbat(final) being charged. The increase in the final charger voltage reaches Vokonv.(final) = Vbat(final) = 3.713 volts, the final charger current becomes Ich(final) = 0.156 A and remains towards the HP battery during charging with a difference in the decrease in charger current towards the HP battery of ∆Ich = 0.009 A relatively small is still profitable, because it avoids back current to the charger voltage.

Effect of Ni content on 475°C embrittlement of directed energy deposited duplex stainless steel using a laser beam and wire feedstock

Duplex stainless steel (DSS), specifically the 2209 grade, is increasingly employed in additive manufacturing, particularly in processes like directed energy deposition using a laser beam with wire (DED-LB/w). However, a significant challenge arises when DSS faces brittleness within the temperature range of 250–500 °C. This study employs advanced characterization techniques, including atom probe tomography (APT) and transmission electron microscopy (TEM), to investigate DSS embrittlement after aging at 400 °C for up to 1000 h. The hardness analysis revealed that the higher Ni content in DED-LB/w-fabricated DSS cylinder promotes the age hardening compared to 2205 wrought DSS plate. Furthermore, APT and TEM demonstrated that, alongside the decomposition of ferrite into Fe-rich (α) and Cr-rich (αʹ) phases, clustering of Ni, Mn, and Si atoms contributes to the embrittlement. Although the Ni-Mn-Si-rich clusters could suggest nucleation of G-phase, the G-phase crystal structure was not observed by TEM. This might be attributed to the short aging time or limitations in the characterization technique. This work underscores the impact of characterization techniques on the measurement of spinodal decomposition, with APT providing capability of detecting nanometer sized clusters. By elucidating the complexities of 475 °C-embrittlement in DED-LB/w DSS, this study offers valuable insights for industrial applications and a deeper understanding of age hardening in duplex DSSs under specific manufacturing conditions.

Laboratory Investigations of the Leica RTC360 Laser Scanner-Distance Measuring Performance.

A Leica RTC360 laser scanner was investigated using a linear horizontal comparator system with four targets of different reflectance. Several thousand panorama scans were conducted along the 30 m long comparator, basically in 40 mm steps. For a selected target, more detailed investigations were carried out with a 2 mm step width for a 2 m wide section. The absolute offset between the scanner and the relative interferometer measurements was determined with a calibrated total station. The investigations revealed several systematic effects like an offset in the distance measurement of about 1.3 mm. Furthermore, sections with stochastic behavior as well as sections with pseudo-cyclic parts were observed, depending on the reflectance of the target. The deterministic sections showed curved and striped patterns with some discontinuities of about 2 mm at 20 m, resulting in a saw-tooth like pattern along the distances. Within all the experiments, the distance deviations were below the manufacturer specifications of the 3D point accuracy. However, it was demonstrated that the distance measurements had clear systematic components. In using these new findings, the specification of the measurement "noise" in the data sheet has to be seen as critical.

Transforming tumor immune microenvironments with a novel systemic enveloped oncolytic virotherapy targeting all tumor sites.

2559 Background: Systemic oncolytic virotherapy offers a promising solution for treating both local and metastatic diseases. However, the rapid inactivation of virotherapeutics by the immune system has resulted in disappointing clinical efficacy. To address this challenge, we have built a new program (ImmunoNova) to develop a cellular-based technology that protects oncolytic virotherapy, allowing for successful targeting of the therapy to tumor sites and effectively overcoming clinical challenges. This approach involves utilizing a newly selected and engineered, tumor-selective strain of vaccinia virus (RT-01). This strain produces high levels of extracellular enveloped virions (EEVs) that contain a second human cell-derived membrane, providing augmented protection against elimination by the immune system when administered systemically. The process requires specific manufacturing methods to preserve this crucial second human cellular membrane. Methods: The resistance of the manufactured enveloped RT-01 (envRT-01) virus against human humoral immunity and its rapid spread were assessed ex-vivo using a plaque assay. EnvRT-01 was administered in various xenograft and syngeneic models to evaluate its specificity in targeting tumors and its therapeutic efficacy, either alone or in combination with cell therapies. The amplification of virus-encoded RFP was monitored using an imaging system. Additionally, flow cytometry and immunohistochemistry (IHC) were employed to analyze immune infiltration in both treated and untreated tumors. Results: EnvRT-01 particles exhibited an approximately 80% survival rate in the presence of active complement. In animal studies, a single systemic dose of envRT-01 selectively targeted three distinct human cancer indications (lung, melanoma, head & neck), leading to the suppression of tumor growth in all three cases. Similarly, in an immunocompetent syngeneic lung tumor model, envRT-01 effectively targeted and reduced multiple murine lung tumors with just a low single dose of treatment. EnvRT-01 was capable of targeting and expressing viral-encoded proteins in all tumor sites and drastically modifying the tumor immune microenvironment, favoring an anti-tumor immune phenotype and facilitating other cell therapies such as innate-based cell therapies. Conclusions: The development of this innovative enveloped oncolytic virotherapeutic, coupled with advancements in its manufacturing methods, opens up new possibilities in the realm of cancer therapy. It addresses the limitations posed by untargetable and untreatable metastatic diseases, presenting a transformative solution with broad implications for the field.

Evaluation of 278 New Bluephase Style Light Curing Units Purchased Over Six Years.

This study measured 278 new curing lights (LCUs) to determine if they met the manufacturer's specifications. Over a 6-year period, the light output from 278 Bluephase Style LCUs was measured before the LCUs were given to students (41 in 2017, 44 in 2018, 46 in 2019, 48 in 2020, 50 in 2021, and 49 in 2022). The radiant exitance (mW/cm²) from each year was compared using ANOVA and Tukey- Kramer multiple comparisons test with adjustment for the unequal sample sizes (α=0.05). The results were also compared against the manufacturer's stated radiant exitance of 1200 mW/cm². The 278 LCUs delivered an average (± standard deviation) radiant exitance of 1203 ± 16.7 mW/cm². The lowest radiant exitance was 1149 mW/cm² and the highest was 1257 mW/cm². Although there were statistically significant differences in the LCUs from each year, these values were within the manufacturer's tolerance of values of ± 10%. Approximately 13% of the emitted light was below 420 nm, and 87% was above 420 nm. These new LCUs were all multiple peak LCUs that emitted an average radiant exitance of 1,203 mW/cm² (range 1149 to 1257 mW/cm². Purchasers of the Style LCU can be confident that their new LCU will meet the manufacturer's specifications.

Clinical and Analytical Comparison of Monoclonal and Polyclonal Immunoassays for Fecal Pancreatic Elastase.

Numerous immunoassays have been commercialized to determine pancreatic elastase (PE) in feces in screening for exocrine pancreatic insufficiency (EPI), but how the different assays compare to one another is controversial, especially in the context that all methods use the same cut-off values for interpreting the results obtained on the presence or absence of EPI or the degree of insufficiency if it is present. Our aim was to analytically verify a new method for determining PE, compare the results with a previous method, and verify the declared cut-off values for interpretation of the results. PE in the stool was assayed using a previous monoclonal enzyme-linked immunosorbent assay ("ScheBo ELISA") and a new polyclonal particle-enhanced turbidimetric immunoassay ("Bühlmann PETIA"). The direct method comparison of two immunoassays was performed in 40 samples. Clinical comparisons were conducted against each other for the binary determination of "abnormal/normal" elastase levels and the three-way determination of "severe/moderate/no" EPI in 56 samples. The indirect comparison method used external quality assessment (EQA) data to compare the monoclonal and polyclonal immunoassays for PE, and additionally compare the monoclonal ScheBo ELISA to a monoclonal chemiluminescence immunoassay ("DiaSorin CLIA"). Precision in the series and intra-laboratory precision for Bühlmann PETIA met the manufacturer's specifications for the concentration range of limit/lower values and the range of normal values. The Bühlmann PETIA immunoassay on different analytical platforms yielded comparable results and nearly perfect agreement in the case of three-way classification (kappa = 0.89 with 95%CI from 0.79 to 1.00. ScheBo ELISA tends to generate higher values of pancreatic elastase than the Bühlmann PETIA; agreement between the methods was moderate in the case of binary classification (kappa = 0.43; 95% CI 0.25 to 0.62), and substantial in the case of three-way classification (kappa = 0.62; 95% CI 0.50 to 0.75). EQA data analysis showed a statistically significant difference between ScheBo ELISA and Bühlmann PETIA peer groups (p = 0.031), as well as the DiaSorin CLIA and ScheBo ELISA peer groups (p = 0.010). The ScheBo ELISA and Bühlmann PETIA do not appear to be commutable in the analytical and clinical context. Our data address a discordance between different mono- and polyclonal immunoassays for pancreatic elastase and the potential of misclassification using its universal cut-off values in screening suspected patients for exocrine pancreatic insufficiency.

Offline robot programming assisted by task demonstration: an AutomationML interoperable solution for glass adhesive application and welding

ABSTRACT Robots have been successfully deployed in both traditional and novel manufacturing processes. However, they are still difficult to program by non-experts, which limits their accessibility to a wider range of potential users. Programming robots requires expertise in both robotics and the specific manufacturing process in which they are applied. Robot programs created offline often lack parameters that represent relevant manufacturing skills when executing a specific task. These skills encompass aspects like robot orientation and velocity. This paper introduces an intuitive robot programming system designed to capture manufacturing skills from task demonstrations performed by skilled workers. Demonstration data, including orientations and velocities of the working paths, are acquired using a magnetic tracking system fixed to the tools used by the worker. Positional data are extracted from CAD/CAM. Robot path poses are transformed into Cartesian space and validated in simulation, subsequently leading to the generation of robot programs. PathML, an AutomationML-based syntax, integrates robot and manufacturing data across the heterogeneous elements and stages of the manufacturing systems considered. Experiments conducted on the glass adhesive application and welding processes showcased the intuitive nature of the system, with path errors falling within the functional tolerance range.

Adaptive Critic Design for Event-Triggered Tracking Control in Discrete-Time on Linear Systems with Observers

This research pioneers an innovative methodology for the bespoke manufacturing of SquidSkin safety products, meticulously tailored to the distinct requisites of diverse industries encompassing medical, military, and defense sectors. The triple DES algorithm is a three instance of DES on same plain text in blocks of 64 bits and converts them to cipher text using keys of 168 bits. The triple DES encryption process creates cipher text, which is an unreadable, effectively indecipherable conversion of plaintext data, the version of information that humans can read and understand. The output of the encryption process, the triple DES cipher text, cannot be read until a secret triple DES key is used to decrypt it. The delineation of industry- specific manufacturing parameters mandates a nuanced approach to material composition and production processes, culminating in a paradigmatic advancement in safety product customization. Integral to this methodology is a rigorous analysis of industry-specific requirements, guiding the selection of optimal material compositions. This selection is underpinned by a meticulously designed material testing phase, ensuring adherence to exacting industry standards and performance benchmarks. Augmenting this paradigm is an imperative emphasis on fortifying the security framework underpinning the handling of proprietary manufacturing data. The proposal introduces an advanced cryptographic architecture, featuring encryption and decryption protocols. Approach assures heightened efficiency, unwavering reliability, and the preservation of proprietary information across varied industry sectors.

Enhancing Solar Photovoltaic Cell Efficiency: A Comparative Analysis of Advanced Materials and Manufacturing Techniques

This research paper investigates the enhancement of solar photovoltaic (PV) cell efficiency through a comparative analysis of advanced materials and manufacturing techniques. With the escalating demand for renewable energy solutions, improving the efficiency of solar cells is paramount. This study focuses on several promising materials including silicon, perovskite, CIGS, organic, and dye-sensitized options, alongside innovative manufacturing techniques such as roll-to-roll printing, ultrasonic spraying, and laser scribing. The methodology employed an experimental approach, where various prototypes were fabricated and tested under controlled laboratory conditions. Regression analysis was utilized to examine the impact of different materials and manufacturing techniques on solar cell performance. Key findings revealed that specific manufacturing techniques, particularly laser scribing, significantly enhance the efficiency of silicon-based cells. Moreover, perovskite cells displayed robust performance under varied environmental conditions, suggesting their broader application potential. Material enhancements such as sodium doping in CIGS cells were also shown to substantially increase efficiency. The implications of these findings are significant, offering insights into the effective integration of materials and techniques that could lead to more cost-effective and efficient solar energy systems. This study not only advances the academic understanding of photovoltaic technologies but also guides practical implementations in the solar industry.

The Role of Workforce Diversity in Improving Organizational Sustainability and Innovation of the Manufacturing Industry in Nigeria

Objectives: The goal of this study was to see how worker diversity affected organisational sustainability and innovation in a specific manufacturing industry in Nigeria. Specifically the study determine the impact of gender, age diversity, ethnic diversity and educational diversity on the sustainability and innovation of organisations. Theoretical Framework: The management research, functional categories, social categories, and psychological research where explored in this study. These categories serve as illustrative examples within the broader context of understanding various dimensions of research in the field of management. Method: The study included a descriptive research design. Individual survey questionnaire were distributed to a sample of 20 companies and 81 participants from the indicated industrial industries. CVR=1 was obtained by using Lawshe's template to test the questionnaire's validity, while Cronbach Alpha was used and supplied a coefficient alpha of 0.86 to establish the questionnaire's homogeneity. Data was collected on-site and analysed using frequency counts and percentages. At p.01 and .05, the Spearman rank correlation coefficient was utilized to evaluate statistical significance. Findings: Gender, age, and educational background are all substantially connected with organizational sustainability and innovation, workforce diversity characteristics have been identified as major predictors of organizational sustainability and innovation, but ethnic diversity has been found to be negatively related to organisational sustainability and innovation. The implication is that the chosen manufacturing firm has an outstanding age, gender, and educational diversity composition, and that it must be handled properly to fully profit from the diversity. Conclusion: The selected manufacturing company must supply various skill maximization training to enhance the employees' current inventive capacity and ensure ethnic variable is handled the positive way to ensure organizational sustainability.

The roots of errors in adaptive performance: clustering behavioral patterns after the introduction of a change

PurposeThe purpose of this study was to investigate work-related adaptive performance from a longitudinal process perspective. This paper clustered specific behavioral patterns following the introduction of a change and related them to retentivity as an individual cognitive ability. In addition, this paper investigated whether the occurrence of adaptation errors varied depending on the type of change content.Design/methodology/approachData from 35 participants collected in the simulated manufacturing environment of a Research and Application Center Industry 4.0 (RACI) were analyzed. The participants were required to learn and train a manufacturing process in the RACI and through an online training program. At a second measurement point in the RACI, specific manufacturing steps were subject to change and participants had to adapt their task execution. Adaptive performance was evaluated by counting the adaptation errors.FindingsThe participants showed one of the following behavioral patterns: (1) no adaptation errors, (2) few adaptation errors, (3) repeated adaptation errors regarding the same actions, or (4) many adaptation errors distributed over many different actions. The latter ones had a very low retentivity compared to the other groups. Most of the adaptation errors were made when new actions were added to the manufacturing process.Originality/valueOur study adds empirical research on adaptive performance and its underlying processes. It contributes to a detailed understanding of different behaviors in change situations and derives implications for organizational change management.

SARS-CoV-2 spike protein expression as an identification in quality control testing for Adenovector based COVID-19 vaccine

AimQuality control testing of the vaccine for lot release is of paramount importance in public health. A recent pandemic caused by the SARS-CoV-2 virus brought together all spheres of vaccine to combat the virus. The scientific advancement in the development of vaccines facilitated the scientists to develop the vaccine against SARS-CoV-2 in a record time. Thus, these vaccines should be stringently monitored for their safety and efficacy as per the latest WHO and national regulatory guidelines, and quality control evaluation of the product should be done at national control laboratories before releasing the product into the market as it assures the quality and safety of the vaccine. MethodsThe SARS-CoV-2 exploited the ACE2 (Angiotensin Converting Enzyme 2) receptor, a surface protein on mammalian cells to gain entry into the host cells. The viral surface protein that interacted with the ACE2 receptor is the Spike protein of SARS-CoV-2. Thus, in the development of the vaccine and assessing its quality, the Spike protein of SARS-CoV-2 became an attractive immunodominant antigen. In National Institute of Biologicals, an apex body in the testing of biologicals in India, received the Adenovector (Adenovirus + vector) based COVID-19 vaccine, a finished product for quality evaluation. Due to the lack of a pharmacopeial monograph, the testing of the vaccine was done as per the manufacturer's specifications and methods. The routine assays of identification employed by the manufacturer do not reflect the expression of Spike protein which is required for the immune system to get activated. In this report, we showed the determination of Spike protein expression by immunoblotting and immunofluorescence for identification parameters in the quality testing of the COVID-19 vaccine. We determined the translation of the SARS-CoV-2 Spike gene cloned into an Adenovector. ResultsThe results from these experiments indicated the expression of Spike protein upon infection of mammalian cells with viral particles suggested that the expression of immunodominant Spike protein of SARS-CoV-2 may be employed by quality control laboratories as a parameter for identification. ConclusionThe study suggested that the determination of the expression of Spike protein is pertinent to identifying the Adenovector based vaccines against COVID-19.

Application of the TOPSIS decision-making method for selecting a manufacturing technique for children’s furniture elements with therapeutic functions

Making furniture or furniture elements that account for the needs of children at various stages of development or with psychomotor dysfunctions is very difficult. From the point of view of exploitation and production technology, it is difficult to select a specific material and manufacturing technique. In this article, the results of using the APEKS method, which is a type of Technique for Order Preference by Similarity to Ideal Solution (TOPSIS) method, are presented to select the best solution for the production of children’s furniture elements with surface structures similar to those of natural materials. Wood bark was selected as a material that, due to the sensory tactile sensations of dysfunctional children, could contribute to therapy and education. Comparative analysis was performed on the basis of the subtractive and additive methods used for manufacturing furniture products. Precise multiaxis milling of ash wood and 3D printing with fused filament fabrication technology using wood PLA filaments were carried out. The method used to select the best option considered quantitative and qualitative criteria in the assessment. Various parameters characterizing the surfaces were analyzed, such as geometric dimensions, hill heights, valley depths, and 3D surface parameters. The quality and surface roughness (Sa, Sz, Ssk, Sku, Sp, and Sv) parameters obtained based on 3D microscope measurements were determined. A scale of 1 to 10 was used to assess qualitative factors (i.e., usability and aesthetics). Based on the critical values obtained from the coefficient Kcri = 79.36, it was assumed that multiaxis wood milling was the best method for producing furniture elements with the required surface characteristics for use as therapeutic and educational tools for children with dysfunctions. The applied method allowed an effective evaluation of the compared variants of the production of furniture elements for customized applications.

Human-centred engineering design: a cross-disciplinary product innovation practice

AbstractThis article introduces a Human-centred Engineering Design (HcED) practice, which values human aspects. This practice engages deeply into (1) human geometry and motion for specific tasks, (2) product and manufacturing complexities through rapid prototyping, and (3) the broader human task context. This cross-disciplinary method combines ergonomics, AM, sensor applications, and multiple design practices. The framework provides concrete tasks to drive innovative designs in engineering. The study, grounded in design research case studies, led to five new Paralympic Rowing world records.

Prototyping industry 4.0: enhancing efficiency and productivity in small enterprises through iteration and low-cost solutions

AbstractThis paper explores the implementation of Industry 4.0 technologies in Small Enterprises (SEs), focusing on the unique challenges they face. It presents four case studies demonstrating how low-cost, low-effort solutions can enhance efficiency and productivity in small companies. The solutions, developed in a local makerspace, address specific manufacturing challenges that lack affordable or existing off-the-shelf solutions. The paper highlights the value of iterative prototyping in implementing Industry 4.0 solutions and discusses how this approach can help SEs overcome adaptation challenges.

FAM19A4 and hsa-miR124-2 Double Methylation as Screening for ASC-H- and CIN1 HPV-Positive Women.

The DNA methylation levels of host cell genes increase with the severity of the cervical intraepithelial neoplasia (CIN) grade and are very high in cervical cancer. Our study aims to evaluate FAM19A4 and hsa-miR124-2 methylation in Atypical Squamous cells with high-grade squamous intraepithelial lesions (ASC-H) and in CIN1, defined as low-grade squamous intraepithelial lesions (LSILs) by the Bethesda classification, as possible early warning biomarkers for managing women with high-risk HPV infections (hrHPV). FAM19A4 and hsa-miR124-2 methylation tests were conducted on fifty-six cervical screening samples from a subset of women aged 30-64 years old. Specimens were collected into ThinPrep PreservCyt Solution. Their HrHPV genotype and cytology diagnosis were known. A Qiasure (Qiagen) was used for FAM19A4 and hsa-miR124-2 methylation testing on bisulfite-converted DNA, according to the manufacturer's specifications. The reported results were hypermethylation-positive or -negative. We found that FAM194A4 and hsa-miR124-2 methylation was detected in 75% of ASC-H cases with a persistent infection of hrHPV. A total of 60% of CIN1 lesions were found to be positive for methylation, and 83.3% were when the cytology was CIN2/3. In addition, as a novelty of this pilot study, we found that combined FAM19A4 and hsa-miR124-2 methylation positivity rates (both methylated) were associated with the HPV genotypes 16, 18, and 59 and covered 22 and 25% of ASC-H and CIN1 cases, respectively. The methylation of these two genes, in combination with HPV genotyping, can be used as an early warning biomarker in the management and follow-up of women with ASC-H and CIN1 to avoid their progression to cervical cancer.

Evaluation of retention for two different designs of digitally fabricated extracoronal attachments after 1 year of simulated aging

Objective To assess changes in dislodging forces for the OT-Cap and OT-Cap Tecno attachment-retained partial dentures throughout 1 year of simulated aging. Patients and methods Fourteen three-dimensional-printed class II mandibular models with last premolars prepared to receive splinted crowns with computer-assisted designing/computer-assisted manufacturing extracoronal attachment were divided into two groups; group I: seven partials retained by OT-Cap attachment and group II: seven partials retained by OT-Cap Tecno attachment. Dislodging forces were measured at baseline (T0), then after; 60 000 cycles of chewing simulation plus 270 cyclic dislodgements (T1), 120 000 cycles of chewing simulation plus 540 cyclic dislodgements (T2), and 240 000 cycles of chewing simulation plus 1080 cyclic dislodgements (T3). Results The independent t test revealed a nonsignificant difference between the mean value of initial retention for each group and the manufacturer specifications. It also revealed that group II exhibited; significantly higher mean values of retention at T1, T2, and T3 with P values (P = 0.002, P < 0.001, and P = 0.016), and lower mean values of retention loss at 0–3 and 0–6 intervals with P values (P < 0.001 and P = 0.011), but, higher mean values of retention loss at the 6–12 interval (P < 0.001). As revealed by repeated-measures analysis of variance; the time-dependent loss of retention was expressed as: 0–3 months more than 3–6 months more than 6–12 months for the OT-Cap group (difference was significant between T2 and T3; P < 0.05), and as; 0–3months less than 3–6 months less than 6–12 months for Tecno group (P < 0.05). Conclusion The precision Tecno attachment offered higher and more durable retention and more uniform retention behavior than its semiprecision counterpart.

Human Medicines Recall Announcements in Saudi Arabia Between 2017 and 2022: An Analysis of Saudi Food and Drug Authority (SFDA) Reports.

This study aims to explore the characteristics of drug recall announcements issued over six years by the SFDA in Saudi Arabia. Additionally, to examine the patterns of voluntary drug recall requests by pharmaceutical companies (both innovator and generic) in response to product defects. A retrospective data analysis was conducted on drug recall announcements issued by the SFDA between 2017 and December 2022. The study included recalls of registered and unregistered drugs posted on the SFDA Drugs Circulars and Withdrawal webpage. Descriptive analysis was performed on relevant variables: recall year, therapeutic class, recall type, pharmaceutical company type, recall reasons and voluntary or involuntary product defect reports. During the study period, a total of 371 products were recalled, with the majority being involuntary recalls (82.4%). About two-thirds of the recalls (66.0%) were related to registered products. The most common reasons for recalls were non-compliance with the manufacturer's specifications (33.2%), contamination (23.7%), and violations (20.5%). A total of 109 pharmaceutical companies were associated with the recalled products, with (85.3%) being generic pharmaceutical companies. The majority of innovator pharmaceutical companies (68.8%) requested voluntary drug recalls of defective products. Innovator pharmaceutical companies requested voluntary recalls more often than generic pharmaceutical companies. The study findings highlight the most frequent causes of drug recalls and the patterns of voluntary recall requests by pharmaceutical companies. Non-compliance with manufacturer's specifications was the most common reason for recalls. Significantly, more innovative pharmaceutical companies request voluntary recalls for product defects compared to generic pharmaceutical companies.

Performance of gender diversity on board of directors: The case of Indonesia

This study further explores women’s role in top management in Indonesia, where men still dominate that position. This study underlines the role of women’s boards of commissioners in producing better financial performance in the specific sectors, manufacturing and service sectors, where the power of women to lead these sectors is more optimal. The sample is selected from the Indonesia Stock Exchange for the period 2009–2018. The final sample is 780 observations. This study applies panel data, which is more robust when controlling heterogeneity. Data panel regression is applied to analyze data. This study finds that gender diversity harms market-based performance, while from accounting-based measures, gender diversity has a significant positive effect. This study is applied explicitly in the manufacturing and services industrial sectors; therefore, carefully generalizing the results is necessary. Research in other specific sectors is very open to obtaining specific results in various industries, including developing countries other than Indonesia. The market has not trusted the role of women in top management; there is still a kind of ‘hidden distrust’ about the capabilities of women in running the top leadership captain. The market needs more substantial evidence to believe in women’s performance on the board of directors. Therefore, it is necessary to provide wider opportunities for women to sit on the board of commissioners, as much as men have.

Abstract 323: Optimization of a liquid biopsy assay to accommodate low cfDNA samples and increase throughput

Abstract Molecular testing that interrogates cell free DNA (cfDNA) from plasma has significant potential value across the cancer care continuum, including early cancer detection, driver mutation identification, and disease recurrence monitoring. To achieve this potential, liquid biopsy assays must be optimized to address multiple challenges. For one, cfDNA quantity in the blood is highly variable, with different amounts present depending on malignancy and stage of progression. This requires optimization to detect low concentrations of circulating tumor DNA (ctDNA) and to accommodate variable tumor fractions. In addition, minimizing assay costs will improve test accessibility and adoption. To address these issues, Genece Health is optimizing their lung cancer liquid biopsy assay to accommodate minimal cfDNA input into library preparation. Furthermore, Genece is testing algorithms that tolerate reduced read depths from low-pass whole genome sequencing (LP-WGS) while maintaining high performance. The Genece lung cancer liquid biopsy assay profiles fragment end-motif and size (FEMS) and fragment coverage signals using LP-WGS (Illumina) and proprietary machine learning algorithms. This study first tested the frequency of end motifs in pooled ctDNA after modifying library preparation (IDT) to reduce reagent volumes from 1X down to 0.5X, 0.25X, and 0.1X of manufacturer specification. A range of cfDNA input from 0.25 ng to 6 ng was tested with each library preparation volume. In addition, LP-WGS read coverage from 5X to 1X was evaluated to assess impact on end motif frequency and assay sensitivity. Performance characterization was further evaluated with a cohort of 50 clinical lung cancer and 100 healthy donor plasma samples tested at 1X and 0.25X library reagent volume. We observed an expected increase in library complexity at higher cfDNA input and library reagent volume. Assay performance was minimally impacted by variable cfDNA input and library reagent volume. However, reducing sequencing read depth is tolerated down to 1.25X depth before increasing the variability of end motif frequencies. These observations are corroborated in the 150 clinical sample cohort. This data shows that by altering standard library preparation conditions and reducing unique read depth, liquid biopsy assays can accommodate a wider range of cfDNA, while concurrently decreasing overall costs. Citation Format: Michael Salmans, Dasom Kim, Andrew Carson, Mengchi Wang, Byung In Lee, Bryan Leatham. Optimization of a liquid biopsy assay to accommodate low cfDNA samples and increase throughput [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 323.