Quality Control Assessment Research Articles

Development of a single nucleotide polymorphism–based strain-identified method for Streptococcus thermophilus CICC 6038 and Lactobacillus delbrueckii ssp. bulgaricus CICC 6047 using pan-genomics analysis

The health benefits conferred by probiotics is specific to individual probiotic strains, highlighting the importance of identifying specific strains for research and production purposes. Streptococcus thermophilus CICC 6038 and Lactobacillus delbrueckii ssp. bulgaricus CICC 6047 are exceedingly valuable for commercial use with an excellent mixed-culture fermentation. To differentiate these 2 strains from other S. thermophilus and L. delbrueckii ssp. bulgaricus, a specific, sensitive, accurate, rapid, convenient, and cost-effective method is required. In this study, we conducted a pan-genome analysis of S. thermophilus and L. delbrueckii ssp. bulgaricus to identify species-specific core genes, along with strain-specific single-nucleotide polymorphisms (SNPs). These genes were used to develop suitable PCR primers, and the conformity of sequence length and unique SNPs was confirmed by sequencing for qualitative identification at the strain level. The results demonstrated that SNPs analysis of PCR products derived from these primers could distinguish CICC 6038 and CICC 6047 accurately and reproducibly from the other strains of S. thermophilus and L. delbrueckii ssp. bulgaricus, respectively. The strain-specific PCR method based on SNPs herein is universally applicable for probiotics identification. It offers valuable insights into identifying probiotics at the strain level that is fit-for-purpose in quality control and compliance assessment of commercial dairy products.

U-Net Convolutional Neural Network for Real-Time Prediction of the Number of Cultured Corneal Endothelial Cells for Cellular Therapy.

Corneal endothelial decompensation is treated by the corneal transplantation of donor corneas, but donor shortages and other problems associated with corneal transplantation have prompted investigations into tissue engineering therapies. For clinical use, cells used in tissue engineering must undergo strict quality control to ensure their safety and efficacy. In addition, efficient cell manufacturing processes are needed to make cell therapy a sustainable standard procedure with an acceptable economic burden. In this study, we obtained 3098 phase contrast images of cultured human corneal endothelial cells (HCECs). We labeled the images using semi-supervised learning and then trained a model that predicted the cell centers with a precision of 95.1%, a recall of 92.3%, and an F-value of 93.4%. The cell density calculated by the model showed a very strong correlation with the ground truth (Pearson's correlation coefficient = 0.97, p value = 8.10 × 10-52). The total cell numbers calculated by our model based on phase contrast images were close to the numbers calculated using a hemocytometer through passages 1 to 4. Our findings confirm the feasibility of using artificial intelligence-assisted quality control assessments in the field of regenerative medicine.

Quality Control and Phytochemical Profiling of a Polyherbal Traditional Indian Medicine by GC-MS method

Introduction: Gomutra (Cow's urine) has been described to be the most effective substance of animal origin. It is useful in treating various diseases due to its pharmacological activities. Nevertheless, due to its pungent smell, palatability, shelf life and fresh availability have always remained a problem. So it is very much essential to modify it into different dosage forms. One of its traditional dosage forms is Gomutrasava, an alcoholic fermented product indicated in the management of Shvitra (vitiligo). Aim & objective: The study is planned for Pharmaceutical preparation and quality control assessment of Gomutrasava. Material & Methods: Gomutrasava was prepared according to a reference from Astanga Hrudaya. This formulation was tested for organoleptic characters and physicochemical parameters, including Gas Chromatography-Mass Spectrometry (GC-MS). Observation & Results: After fermentation colour of Gomutrasava appeared dark brown with specific cow urine smell. pH, specific gravity at 25ºC, reftractive index, brix, viscocity, total solid content, alcohol content, reducing sugar, non reducing sugar of Gomutrasava were 5.41, 0.967 wt/ml, 1.394, 37º, 1.38/sec, 37%, 6%, 0.96%, 0.07% respectively and test for methanol and microbial contamination were negative. GC-MS revealed some compounds attributed to antimicrobial, anticancerous and antifungal activities. Conclusion Thus this data combined with analytical data will be used for clinical study and treatment of Shvitra (Vitiligo), Kushtha (Leprosy) and various skin diseases.

An RNA-seq atlas of mouse brain areas during fasting and diet-induced obesity

Mammalian energy homeostasis is primarilly regulated by the hypothalamus and hindbrain, with the hippocampus, midbrain nuclei, and other regions implicated by evidence from human genetics studies. To understand how these non-canonical brain regions respond to imbalances in energy homeostasis, we performed two experiments examining the effects of different diets in male C57BL6 mice. In our first study, groups of six pair-housed mice were given access to chow, high-fat diet or fasted for 16 hours. In our subsequent study, two groups of 10 mice were single-housed and given access to chow or fasted for 24 h. We recorded food intake for each cage, the change in body weight for each animal, and collected hypothalamus, hippocampus, superior colliculus, inferior colliculus, frontal cortex, and zona incerta-centric samples. We performed bulk RNA sequencing on 185 samples and validated them by a series of quality control assessments including alignment quality and gene expression profiling. We believe these studies capture the transcriptomic effects of acute fasting and high-fat diet in the rodent brain and provide a valuable reference.

The Influence of Microstructure Characteristics on Thickness Measurement of TBCs Using Terahertz Time-Domain Spectroscopy

Thermal barrier coatings (TBCs) exhibit excellent thermal insulation capabilities, proving crucial in enhancing the performance of turbine blades. Accurate measurement of TBC thickness is pivotal for the quality control and health monitoring of turbine blades. However, the absence of suitable non-destructive testing (NDT) methods poses a challenge in ensuring precise quality control and health assessment of TBCs. This study investigates the efficacy of terahertz time-domain spectroscopy (THz-TDS) in measuring TBCs thickness, specifically focusing on the microstructure characteristics of the top coat (TC), including grain morphology, internal porosity, surface roughness, and agglomerates. The findings emphasize the significance of grain morphology in determining thickness measurement due to the varied terahertz wave propagation modes. Moreover, the study involved polishing EB-PVD and APS samples to mitigate surface roughness. This process revealed a discernible linear correlation between reduced surface roughness and decreased measurement errors. The slopes of the error reduction curves ranged from 0.59 to 1.7 for EB-PVD and 2.17 to 5.79 for APS samples. Furthermore, the research observed THz light scattering within internal pores, resulting in diminished outgoing energies and subsequent increments in measurement errors.

Orally disintegrating tablets: formulation, preparation, and quality control assessment

Orally disintegrating tablets (ODTs) are a new formulation that dissolves in saliva within seconds, and there is no need to drink water. Due to its many benefits, this dosage form is an effective way to administer active pharmacological substances, especially for pediatric, geriatric, psychiatric, paralyzed, and bedridden patients. ODTs have been shown to have superior patient compatibility and drug solubility in numerous studies that have compared this tablet form with conventional forms in vitro and in vivo. There are many substances used to achieve enhanced characteristics, including super disintegrants such as croscarmellose sodium and crospovidone to achieve rapid disintegration and dissolution, and selection of appropriate diluent, binder, sweetening agents, flavoring materials, and lubricant are required to make tablets dissolve quickly. This dosage type can be prepared in several techniques, including direct compression, sublimation, freeze-drying, lyophilization, spray drying, molding, Process of cotton candy, Massextrusion, phase extrusion, and Melt Granulation. Formulation and selection of appropriate excipients are discussed, and ODTs' preparation techniques are illustrated in this review. Laboratory evaluation and quality control measures, including precompression (micromeritics parameters) to adjust formulation and obtain the optimized formulations to be produced and scale up and post-compression parameters for ODTs, are also discussed in this review.

Pharmaceutical Analysis and Evaluation of In-vitro Antibacterial Activity of Gomutra Ghana: A Concentrated and Solidified Form of Cow’s Urine

Introduction: Cow’s urine has been described as a highly effective animal-derived substance. Its therapeutic and pharmacological actions make it effective in the treatment of a variety of disorders. One of its notable properties is its antibacterial action, where the drug’s ability to target and inhibit the growth of bacteria. However, due to the pungent odour and taste of cow’s urine, it is difficult to consume in its natural form. Additionally, the collection of fresh cow’s urine can be challenging, especially in urban areas where access to cows may be limited. So, it is important to modify it into a dosage form, like Gomutra Ghana, which improves palatability and shelf life. Aim: To study the pharmaceutical development, quality control assessment, and in-vitro antibacterial activity evaluation of Gomutra Ghana. Materials and Methods: The pharmaceutical and analytical studies were carried out in Mahatma Gandhi Ayurved College Hospital and Research Centre and Dattatraya Ayurved Pharmacy, Salod (H), Wardha, Maharashtra, India. The in-vitro (antibacterial) study was carried out in JNMC, Sawangi (M), Wardha, Maharashtra, India, from April 2022 to August 2023. The in-vitro antibacterial study of cow’s urine and Gomutra Ghana was performed on five bacterial strains. Fresh cow’s urine was collected from a goshala (cowshed), and Gomutra Ghana was prepared in three batches by boiling the cow’s urine to a thicker consistency, then sun-drying it, followed by drying in an electric dryer. The final product was stored in a clean, sealed glass jars. Analytical parameters like pH, loss on drying at 105ºC, total ash, water-soluble ash, acid-insoluble ash, water-soluble extractives, alcohol-soluble extractives, and microbial contamination were studied. The in-vitro antibacterial activity was evaluated using the agar disc diffusion method at concentrations of 5 μL, 10 μL, and 15 μL, with results compared to those of a broad-spectrum and commonly used antibiotic, ciprofloxacin (5 μg). Statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 27.0, employing Analysis of Variance (ANOVA) to compare three groups (Ciprofloxacin, cow’s urine, and Gomutra Ghana) at all three concentrations. A significance level was set with a p-value of <0.05 for the antibacterial study. Results: High-Performance Thin-Layer Chromatography (HPTLC) showed a peak from cow’s urine and Gomutra Ghana, with maximum heights of 500.1 and 450.4, which were nearly the same, so they may contain similar constituents. An extra peak was observed in Gomutra Ghana, suggesting the presence of additional compounds formed during its preparation. Gomutra Ghana extract showed the highest zone of inhibition against Escherichia coli. Conclusion: Gomutra Ghana showed antibacterial properties, which warrant further exploration in humans for safety and efficacy in humans.

Quality Control Assessment of Human Adipose-Derived Hydrogels.

Decellularized human-adipose tissue (hDAT) can serve as an alternative to two-dimensional monolayer culture and current ECM hydrogels due to its unlimited availability and cytocompatibility. A major hurdle in the clinical translation and integration of hDAT and other hydrogels into current in vitro culture processes is adherence to current good manufacturing practices (cGMP). Transferring of innovative technologies, including hydrogels, requires the establishing standardized protocols for quality assurance and quality control (QA/QC) of the material.Integration of basic characterization techniques, including physiochemical characterization, structural/morphological characterization, thermal and mechanical characterization, and biological characterization, in addition to the reduction of batch-to-batch variability and establishment of proper sterilization, storage, and fabrication processes verifies the integrity of the hydrogel. Obatala Sciences has established a characterization protocol that involves a series of assays including the evaluation of gelation properties, protein content, glycosaminoglycan content, soluble collagen content, and DNA content of hDAT.

Quality Control of an Isogenic H/N/KRAS-Less Mouse Embryonic Fibroblast Cell Line Panel.

Isogenic H/N/KRAS-less mouse embryonic fibroblast (MEF) cell lines have been developed to assist in cell-based assays of RAS inhibitors. The quality control assessment of a panel of these isogenic MEFs is described here, with a focus on ensuring the proper insertion of the desired mutant RAS transgene, a determination of gene copy number, and an investigation of potential off-target mutations which could lead to phenotypes which are undesired in downstream experiments. Using this suite of quality control tools, a MEF cell line can be readily validated, and researchers can be assured of the rationale for an observed phenotype.

Effectiveness of multidisciplinary interventions to improve blood culture efficiency and optimize antimicrobial utilization.

The low positive rate of blood cultures often leads to downstream consequences. We present a summary of multidisciplinary interventions implemented by a tertiary referral hospital to improve blood culture efficiency and optimize antimicrobial usage. We evaluated the knowledge, attitude, and practice (KAP) of healthcare workers in a tertiary care hospital before and after intervention using a questionnaire. A multidisciplinary team was formed to implement the intervention, defining roles, standardizing procedures, continually improving education and feedback, and establishing incentive mechanisms. Regular quality control assessments are conducted on the responsible departments. Following the intervention, the median submission time for blood culture specimens was reduced from 2.2 h to 1.3 h (p < 0.001). Additionally, the intervention group showed significant (p < 0.05) increases in rates of positivity (9.9% vs. 8.6%), correct timing (98.7% vs. 89.6%), correct processing (98.1% vs. 92.3%), reduced contamination rates (0.9% vs. 1.4%), and disqualification rates (1.3% vs. 1.7%). The delivery rate of therapeutic antibacterial increased (16.1% vs. 15.2%), and the consumption of restrictive grade antimicrobial also significantly increased (26.7% vs. 22.9%). The intervention measures led to a substantial improvement in awareness and compliance with KAP of blood culture collection in the hospital. Hospital-wide antimicrobial usage deceased by 10.7% after intervention. A multidisciplinary collaborative model proves effective in improving blood culture efficiency and optimizing antimicrobial usage.

Comparative Quality Control Assessment of Different Brands of Rasayana Churna Available in Indian Market

Introduction: Quality assessment is imperative to establish safety and effectiveness of a drug. Rasayana Churna (RC) is a classical Ayurvedic formulation indicated in various diseases. Present study has been endeavoured to generate comparative analytical profile of different marketed brands of Rasayana Churna in India. Material &amp; Methods: Rasayana Churna was prepared as per the method mentioned in Ayurvedic Formulary of India and marketed RC samples of GMP certified pharmacies were procured from local market in New Delhi and coded as Brand A to Brand G. all the samples were evaluated for organoleptic, physicochemical, phytochemical, HPTLC, FTIR, UV spectroscopy and PCA analysis. Results: All the samples of Rasayana Churna have shown similar organoleptic characteristics but exhibited difference in their pharmaceutical (carr’s index etc.), physicochemical, HPTLC, FTIR, UV-Vis spectroscopy and PCA profiles. Most of the quality parameters values were found in line with previously reported studies but major difference in value of quality parameters has been observed. Conclusion: The present study revealed inter sample variability in various quality control parameters. In order to limit this variability, quality certification for raw drug and adoption of uniform SOP/SMP should be made essential to ensure the quality of finished product. Apart, in order to achieve greater accuracy in findings, further quality control studies can be initiated involving different marketed samples of a drug manufactured at same point of time.

An RNA-Seq Data Analysis Pipeline.

In this chapter, we present an established pipeline for analyzing RNA-Seq data, which involves a step-by-step flow starting from raw data obtained from a sequencer and culminating in the identification of differentially expressed genes with their functional characterization. The pipeline is divided into three sections, each addressing crucial stages of the analysis process. The first section covers the initial steps of the pipeline, including downloading of the data of interest and performing quality control assessment. Assessment ensures that the data used for analysis is reliable and suitable for downstream analyses. In the second section, gene-level quantification is performed, which entails quantification of expression levels of genes in the samples. The third and final section is focused on differential expression analysis, which involves comparing gene expression levels between two or more conditions. This step helps identify genes that show significant differences in expression levels under different experimental conditions. To facilitate accessibility and reproducibility, we have provided an online repository containing all scripts and files. Additionally, custom scripts are available, enabling users to modify the pipeline's output for various downstream analyses. By following this pipeline, researchers can effectively analyze RNA-Seq data and gain valuable insights into gene expression patterns and, furthermore, the understanding of biological processes.

Applications of Artificial Intelligence and Machine Learning in Food Quality Control and Safety Assessment

Applications of Artificial Intelligence and Machine Learning in Food Quality Control and Safety Assessment

A study of volatiles of young citrus fruits from four areas based on GC–MS and flash GC e-nose combined with multivariate algorithms

The present study has successfully established a scientific and precise approach for distinguishing the geographical origins of young citrus fruits (Qingpi) from four primary production regions in China, using gas chromatography-mass spectrometry (GC–MS) and flash gas chromatography electronic nose (flash GC e-nose) to analyze the volatile composition and odor characteristics. Through the application of chemometric analysis, a clear differentiation among Qingpi samples was established using GC–MS. Additionally, the application of flash GC e-nose facilitated the extraction of flavor information, which enabled the discrimination of geographical origins. Several flavor components were identified as significant factors for origin certification. Furthermore, two pattern recognition algorithms were employed to achieve high accuracy in regional identification. The results of this investigation demonstrate that the amalgamation of multivariate chemometrics and algorithms can proficiently discern the sources of those young citrus fruits. The findings of this research can provide a reference for the assessment of quality control in food and other agricultural commodities in the times ahead.

Ursa: A Comprehensive Multiomics Toolbox for High-Throughput Single-Cell Analysis.

The burgeoning amount of single-cell data has been accompanied by revolutionary changes to computational methods to map, quantify, and analyze the outputs of these cutting-edge technologies. Many are still unable to reap the benefits of these advancements due to the lack of bioinformatics expertise. To address this issue, we present Ursa, an automated single-cell multiomics R package containing 6 automated single-cell omics and spatial transcriptomics workflows. Ursa allows scientists to carry out post-quantification single or multiomics analyses in genomics, transcriptomics, epigenetics, proteomics, and immunomics at the single-cell level. It serves as a 1-stop analytic solution by providing users with outcomes to quality control assessments, multidimensional analyses such as dimension reduction and clustering, and extended analyses such as pseudotime trajectory and gene-set enrichment analyses. Ursa aims bridge the gap between those with bioinformatics expertise and those without by providing an easy-to-use bioinformatics package for scientists in hoping to accelerate their research potential. Ursa is freely available at https://github.com/singlecellomics/ursa.

HTA213 Undertaking Studies to Inform Public Policy: Managing Data Collection to Ensure Data Quality in the EQ-5D-5L UK Valuation Through the Use of Independent Quality Control Assessments

HTA213 Undertaking Studies to Inform Public Policy: Managing Data Collection to Ensure Data Quality in the EQ-5D-5L UK Valuation Through the Use of Independent Quality Control Assessments

Head‐to‐head comparison of aptamer‐ and antibody‐based proteomic platforms in CSF samples of a real‐world large cohort of a memory clinic

AbstractBackgroundHigh‐throughput proteomic platforms are an useful strategy to detect novel biomarkers and pathways involved in Alzheimer’s disease (AD) development. Due to the novelty of these techniques, an extensive quality control assessment is needed to ensure the reliability of those protein measurements. In this study, we aimed to assess the reproducibility and reliability of SomaScan and Olink proteomic platforms and select top‐performing proteins for further analysis.MethodTo assess CSF proteomic measurements, we used the SomaScan 7k platform (an aptamer‐based technique) measuring 7335 human proteins, and Olink proteomics platform (Explore panel, an antibody‐based technique), measuring 3072 proteins in a subset of 509 individuals from ACE Alzheimer Center Barcelona (Spain). To assess intra‐ and inter‐platform reproducibility and reliability, we evaluated 1) the correlations of aptamers of two studies carried out in the same samples with SomaScan platform and 2) the correlation between SomaScan vs Olink proteomics, respectively. Then, we created a metric of 6 categories of reproducibility combining both intra and inter‐ correlation analysis, considering good (r &gt; 0.5), modest (0.2 &gt; r ≥ 0.5), poor (r ≤ 0.2) correlation. We considered proteins in the top 3 categories as potential candidates to further analysis.ResultFrom the intra‐platform analysis, only 2402 proteins (35.45%) showed a Pearson’s correlation higher than 0.5. Regarding inter‐platform assessment, 2160 proteins were overlapping between both platforms. From these overlapping proteins, 712 proteins exhibited a Pearson’s r &gt; 0.5 (26.67%). We considered potential candidate proteins those with good intra‐ and inter‐platform correlation (n = 687, 9.02%), only good intra‐platform correlation (n = 2015, 26.45%) and modest intra‐ and inter‐platform correlation (n = 5, 0.06%) for analysis.ConclusionThe validation of the reproducibility and reliability of the new proteomics platforms is essential for the correct analysis of the results. The classification of measured proteins in different categories could be useful to increase the confidence in these highly multiplexed proteomic panels.

Monitoring thermal stability of pure and adulterated sesame oil using Fourier transform infrared spectroscopy and chemometric analysis

This work investigates the application of Fourier Transform Infrared spectroscopy (FTIR) combined with chemometrics as a rapid and non-destructive tool for monitoring the thermal stability of pure sesame oil (SeO) as well as SeO blends with adulterants, including corn, soybean, and sunflower oils in different proportions (99 + 1, 95 + 5, 90 + 10, and 80 + 20 in volume). The oil samples were subjected to thermal treatment at five temperatures (25, 60, 100, 150, and 180 °C) as a function of time up to 96 h. FTIR provided sensitive approach for analysing thermal degradation and compositional changes of pure and adulterated SeO under controlled temperature conditions during varied heating times. Principal component analysis (PCA) was used to discriminate pure SeO at different treatment conditions. In addition, soft independent modelling class analogy (SIMCA) was useful to differentiate between pure and adulterated samples, and the results showed high precision and accuracy, enabling successful discrimination, with a maximum error rate of 6.00%. Finally, partial least squares regression (PLSR) models were developed and showed a good linear correlation between the FTIR signals at different conditions and the proportion of pure SeO. The root mean square of prediction (RMSEP) ranges between 0.8802 and 2.3827 with a coefficient of determination (R2) between 0.9841 and 0.8834, respectively. These findings demonstrate the efficacy of FTIR combined with chemometrics in detecting adulteration in SeO, thus offering a solution for quality control and food safety assessments in the food industry.

A GMP-Compliant Procedure for the Generation of Gene-Modified T cells.

The field of Adoptive Cell Therapy (ACT) has been revolutionized by the development of genetically modified cells, specifically Chimeric Antigen Receptor (CAR)-T cells. These modified cells have shown remarkable clinical responses in patients with hematologic malignancies. However, the high cost of producing these therapies and conducting extensive quality control assessments has limited their accessibility to a broader range of patients. To address this issue, many academic institutions are exploring the feasibility of in-house manufacturing of genetically modified cells, while adhering to guidelines set by national and international regulatory agencies. Manufacturing genetically modified T cell products on a large scale presents several challenges, particularly in terms of the institution's production capabilities and the need to meet infusion quantity requirements. One major challenge involves producing large-scale viral vectors under Good Manufacturing Practice (GMP) guidelines, which is often outsourced to external companies. Additionally, simplifying the T cell transduction process can help minimize variability between production batches, reduce costs, and facilitate personnel training. In this study, we outline a streamlined process for lentiviral transduction of primary human T cells with a fluorescent marker as the gene of interest. The entire process adheres to GMP-compliant standards and is implemented within our academic institution.

Recent developments in flexible printed electronics and their use in food quality monitoring and intelligent food packaging

The field of flexible printed electronics has undergone significant advancements, promising transformative applications across various industries. This comprehensive review explores the integration of flexible printed electronics into the domain of food quality monitoring and intelligent food packaging. The importance of maintaining food product quality throughout the supply chain is paramount, and flexible electronics offer innovative solutions to address this challenge. Regulatory compliance and standardized testing protocols are emphasized to facilitate adoption. Real-world implementation studies assess cost-effectiveness, reliability, and impact within practical food supply chains. Understanding consumer acceptance and education is crucial for successful adoption. Ensuring data security and privacy is addressed to maintain trust and compliance. The review underscores research gaps, including integrating multiple sensors, ensuring long-term reliability, cost-effective manufacturing, and enhancing wireless communication capabilities. The methodology section outlines a structured approach to research, including material selection, printing optimization, quality control, environmental testing, and scalability assessments. The results and discussion section presents insights from data analysis, including scatter plots, histograms, bar charts, box plots, and a line chart depicting sensor reliability over time. The correlation matrix heatmap reveals relationships between variables, and hypothesis testing confirms significant differences in material and production costs. The review concludes with future research and application recommendations, highlighting the potential for flexible printed electronics to revolutionize food quality assurance and intelligent packaging. This comprehensive review serves as a valuable resource for researchers, practitioners, and policymakers interested in the intersection of flexible electronics and food industry applications, offering insights, challenges, and opportunities in this rapidly evolving field.