Quality Control Considerations Research Articles

Unveiling the power of proteomics in advancing tropical animal health and production.

Proteomics, the large-scale study of proteins in biological systems has emerged as a pivotal tool in the field of animal and veterinary sciences, mainly for investigating local and rustic breeds. Proteomics provides valuable insights into biological processes underlying animal growth, reproduction, health, and disease. In this review, we highlight the key proteomics technologies, methodologies, and their applications in domestic animals, particularly in the tropical context. We also discuss advances in proteomics research, including integration of multi-omics data, single-cell proteomics, and proteogenomics, all of which are promising for improving animal health, adaptation, welfare, and productivity. However, proteomics research in domestic animals faces challenges, such as sample preparation variation, data quality control, privacy and ethical considerations relating to animal welfare. We also provide recommendations for overcoming these challenges, emphasizing the importance of following best practices in sample preparation, data quality control, and ethical compliance. We therefore aim for this review to harness the full potential of proteomics in advancing our understanding of animal biology and ultimately improve animal health and productivity in local breeds of diverse animal species in a tropical context.

Impact of active pharmaceutical ingredient variables and oleaginous base on the in vitro drug release from ophthalmic ointments: An investigation using dexamethasone as a model drug

The present study systematically investigates the impact of active pharmaceutical ingredient (API) variables and oleaginous base characteristics on the in vitro release (IVR) performance of ophthalmic ointments, utilizing dexamethasone as a model drug. The interplay between selected attributes (i.e., particle size distribution, crystallinity, and polymorphic form for API, and rheological factors for compendial-grade white petrolatum) and IVR performance was investigated. APIs from different vendors exhibited variations in crystallinity and polymorphism. Ointments containing amorphous dexamethasone presented higher release amounts/rates compared to crystalline counterparts, emphasizing the role of physical state in release kinetics. Variations in particle size of this lipophilic API (5.4 – 21.2 µm) did not appear to impact IVR performance significantly. In contrast, white petrolatum's rheological attributes, which varied substantially within USP-grade petrolatum, were found to critically affect the drug release rate and extent of the ointment. The study’s comprehensive analysis establishes a coherent connection between the quality attributes of both API and petrolatum and IVR, delineating their intricate interdependent effects on ophthalmic ointment performance. These findings provide reference to formulation design, quality control, and regulatory considerations within the pharmaceutical industry, fostering a robust foundational understanding of commonly overlooked quality attributes in ophthalmic ointments.

Cholesterol Absorption Inhibition by Some Nutraceuticals.

Hyperlipidemia, characterized by elevated levels of lipids in the blood, represents a major risk factor for cardiovascular diseases, a leading cause of morbidity and mortality worldwide. Conventional pharmacological interventions have been effective in managing hyperlipidemia, but concerns about side effects and long-term use have prompted interest in alternative approaches, particularly the use of nutraceuticals. This comprehensive review aims to summarize and critically evaluate the current body of knowledge surrounding the role of nutraceuticals in the management of hyperlipidemia. We provide an overview of the different classes of nutraceuticals, including plant sterols, omega-3 fatty acids, soluble fiber, antioxidants, and various herbal extracts, which have been investigated for their lipid-lowering properties. The mechanisms of action of these nutraceuticals are discussed, highlighting their ability to modulate lipid metabolism, reduce oxidative stress, and promote cardiovascular health. Furthermore, we review the results of clinical trials and epidemiological studies that have assessed the efficacy of nutraceutical interventions in lowering cholesterol levels, improving lipid profiles, and reducing the risk of cardiovascular events. In addition to their lipid-lowering effects, we examine the safety profile, dosage recommendations, and potential interactions of nutraceuticals with conventional lipid-lowering medications. We also address the importance of patient adherence to dietary and lifestyle modifications in conjunction with nutraceutical supplementation. While nutraceuticals offer a promising avenue for managing hyperlipidemia, we emphasize the need for further research to establish evidence-based guidelines for their use in clinical practice. Challenges related to standardization, quality control, and regulatory considerations are also discussed. In conclusion, this comprehensive review provides valuable insights into the potential of nutraceuticals as adjunctive or alternative therapies for managing hyperlipidemia. While further research is needed, the accumulating evidence suggests that nutraceuticals can play a valuable role in promoting cardiovascular health and reducing the burden of hyperlipidemia- related diseases.

Identification of the efficacy of parentage testing based on bi-allelic autosomal single nucleotide polymorphism markers in Taiwanese population.

Parentage testing is crucial for forensic DNA analysis, using short tandem repeats (STRs). Single nucleotide polymorphisms (SNPs) with high minor allele frequency (MAF) are promising for human identification. This study aimed to develop SNP markers for parentage testing in the Taiwanese population and compare their accuracy with STRs. The TPMv1 SNP microarray (714,457 SNPs) was used to screen 180,000 Taiwanese individuals and analyze the SNP data using PLINK. After quality control, allelic distribution, and MAF considerations, a set of SNPs with significant inheritance information was selected. Parentage testing was conducted on 355 single parent-child pairs using both STRs and SNPs, employing three kinship algorithms: identity by descent, kinship-based inference for genome-wide association studies, and the combined paternity index/probability of paternity (CPI/PP). An Affymetrix signature probe for kinship testing (ASP) was also used. Based on the quality control and selection criteria, 176 SNPs with MAF > 0.4995 were selected from the Taiwanese population. The CPI/PP results calculated using SNPs were consistent with the STR results. The accuracy of the SNPs used in the single-parent-child parentage testing was > 99.99%. The set of 176 SNPs had a higher identification rate in the single parent-child parentage test than in the ASP. The CPI/PP value calculated using 176 SNPs was also more accurate than that calculated using ASP. Our findings suggest that these 176 SNPs could be used for single-parent-child parentage identification in the Taiwanese population.

PROBIOTICS UNVEILING THE MICROBIAL ALLIES IN HUMAN HEALTH AND BEYOND

The burgeoning field of probiotics has ushered in a new era in health and well-being, offering a deeper understanding of the intricate interplay between the human microbiome and our physiological systems. This review paper delves into the multifaceted world of probiotics, tracing their historical origins from traditional fermented foods to their modern applications in clinical settings. The paper explores the mechanisms through which probiotics exert their influence on human health, highlighting their role in enhancing gut barrier function, modulating the immune response, and producing antimicrobial substances. Probiotics are celebrated for their diverse health benefits, spanning from digestive health to mental well-being. They have demonstrated efficacy in managing gastrointestinal disorders, preventing antibiotic-associated diarrhea, and promoting oral health. Safety considerations and adherence to guidelines remain vital in their responsible use, particularly in individuals with compromised immune systems. The future of probiotics is illuminated with the promise of personalized regimens, targeted microbial therapies, and the discovery of novel strains. Challenges pertaining to regulation, quality control, and ethical considerations urge the adoption of informed practices in probiotic utilization. As the field continues to evolve, probiotics emerge as more than just "good" bacteria; they represent a transformative force in optimizing human health and well-being. This review navigates the complex terrain of probiotics, offering insights into their current state, future potential, and the implications they hold for holistic healthcare. Keywords: Probiotic, Gut microbiota, digestive health, Immune modulation, Clinical application, personalized nutrition, Gastrointestinal Disorders, Microbial therapies,

Measuring excess attenuation in littoral environments: Evolution of a measurement system

Atmospheric sound propagation measurements over long distances are generally lacking in the literature. This work presents the evolution of the system deployed to collect high spatial and temporal resolution synchronized acoustic and meteorological data. Specifically, the mature configuration includes: a long-range acoustic device capable of source levels up to 140 dB; up to four 7-channel acoustic arrays; two 7-m temperature profiling masts; and a scanning Doppler LIDAR system for volumetric wind profiling at ranges up to several kilometers. This work presents lessons learned over the various iterations of the system such as the design and evolution of the excitation signal used; physical configuration of the components of the system; logistics and planning concerns; post-processing challenges; and quality control considerations.

An exploration into the impact of citizen journalism on traditional journalism in Lesotho

In recent years, technological advancement in communication has given citizens opportunities to be recipients and purveyors of news. Social networking sites propagate citizen journalism, wherein ordinary citizens without professional training gather and disseminate information. This has presented a number of challenges due to limited quality control standards for determining what constitutes news. The study thus sought to establish the depth and breadth of the impact of citizen journalism on traditional journalism in Lesotho. The study used the qualitative methodology embedded in a case study design. The in-depth face-to-face interviews with (n=10) journalists were conducted to get insight into the impact citizen journalism has on traditional media. The respondents were selected using a purposive sampling technique. In this case, respondents were selected based on their availability and knowledge of the subject at hand. The findings were analysed using thematic analysis to interpret the findings. The results revealed that citizen journalism had posed an imminent threat to traditional journalism as it plays a complementary role. It was also discovered that the fast passed nature of citizen journalists compromises the quality of the content. The study also revealed that mainstream media professionals face fierce competition from citizen journalism, resulting in poor-quality stories. Therefore, the study recommends that mainstream media should have platforms where citizen journalists can submit content that can be vetted for quality control and ethical considerations.

City Wind Impact on Air Pollution Control for Urban Planning with Different Time-Scale Considerations: A Case Study in Chengdu, China

Economic development and fast growing urbanization in China have caused severe air pollution, with frequent pollution episodes endangering the health of inhabitants and disturbing social activities, and as an expanding metropolis, Chengdu has suffered ever since. The concentration variations of main air pollutants, such as PM10, PM2.5 and NO2, often show periodicity because of meteorological impact and anthropic activities, and display orientation discrepancies due to influences of wind speed (WS), frequency and pollutant sources. These features have complicated the mechanisms of pollution episodes and deepened the difficulty in pollution control evaluation. The WS has significant influences on the periodicity and orientation variations in pollutant concentrations, and quantifying the influence of which is of high significance and provides sustainable foundations for pollution alleviation strategies. Different time-scale cycles (i.e., Diurnal, weekly, seasonal and annual), along with the WS, wind frequency, wind and spatial orientations in urban areas, were analyzed in this paper. Results show that the periodicity of diurnal, seasonal and annual cycles is remarkable, and weekly cycle is obvious by adding the influence of the WS in 16 orientations. The WS has direct impacts on pollutants varying in the range of 1.5–2.5 m/s, and has a remarkable diffusion effect on pollutants once above 2.5 m/s. Over heavy pollution hours in diurnal, weekly, annual cycles and transitional seasons, the WS had more significant influences on pollutants, and whereas the wind frequency is not the main impact factor for orientation variations. For Chengdu, the northeast orientation is suitable to construct a wind panel with a remarkable diffusion effect on pollutants, while air pollutions in the northwest and southwest orientations were severe with the WS below 1.5 m/s, and pollution diffusion in the north-northwest orientation was the worst. This work can provide guidance and reference for urban planning optimization and air environment protection in cities with air quality control considerations impacted by city wind.

Data quality control considerations in multivariate environmental monitoring: experience of the French coastal network SOMLIT

IntroductionWhile crucial to ensuring the production of accurate and high-quality data—and to avoid erroneous conclusions—data quality control (QC) in environmental monitoring datasets is still poorly documented.MethodsWith a focus on annual inter-laboratory comparison (ILC) exercises performed in the context of the French coastal monitoring SOMLIT network, we share here a pragmatic approach to QC, which allows the calculation of systematic and random errors, measurement uncertainty, and individual performance. After an overview of the different QC actions applied to fulfill requirements for quality and competence, we report equipment, accommodation, design of the ILC exercises, and statistical methodology specially adapted to small environmental networks (<20 laboratories) and multivariate datasets. Finally, the expanded uncertainty of measurement for 20 environmental variables routinely measured by SOMLIT from discrete sampling—including Essential Ocean Variables—is provided.Results, Discussion, ConclusionThe examination of the temporal variations (2001–2021) in the repeatability, reproducibility, and trueness of the SOMLIT network over time confirms the essential role of ILC exercises as a tool for the continuous improvement of data quality in environmental monitoring datasets.

Tolerance of membrane with additive to iron contamination in PEM fuel cell

Contamination is one major contributor to the degradation of proton exchange membrane (PEM) fuel cell performance and lifetime. Aiming to evaluate the tolerance of PEM doped with radical scavenger additives to metal ions contamination, iron (Fe) ion was selected in this work as a representative of impurities that could come from current metal bipolar plates and directly introduced into the membrane. It has been found that the membrane additives could not only provide durability benefits but also enhance Fe3+ contamination tolerance without any performance loss. These scientific findings provide valuable guidelines for membrane developers and PEM fuel cell manufacturers on quality control (QC) considerations during the production of fuel cell components.

Mitochondrial single-cell ATAC-seq for high-throughput multi-omic detection of mitochondrial genotypes and chromatin accessibility.

Natural sequence variation within mitochondrial DNA (mtDNA) contributes to human phenotypes and may serve as natural genetic markers in human cells for clonal and lineage tracing. We recently developed a single-cell multi-omic approach, called 'mitochondrial single-cell assay for transposase-accessible chromatin with sequencing' (mtscATAC-seq), enabling concomitant high-throughput mtDNA genotyping and accessible chromatin profiling. Specifically, our technique allows the mitochondrial genome-wide inference of mtDNA variant heteroplasmy along with information on cell state and accessible chromatin variation in individual cells. Leveraging somatic mtDNA mutations, our method further enables inference of clonal relationships among native ex vivo-derived human cells not amenable to genetic engineering-based clonal tracing approaches. Here, we provide a step-by-step protocol for the use of mtscATAC-seq, including various cell-processing and flow cytometry workflows, by using primary hematopoietic cells, subsequent single-cell genomic library preparation and sequencing that collectively take ~3-4 days to complete. We discuss experimental and computational data quality control metrics and considerations for the extension to other mammalian tissues. Overall, mtscATAC-seq provides a broadly applicable platform to map clonal relationships between cells in human tissues, investigate fundamental aspects of mitochondrial genetics and enable additional modes of multi-omic discovery.

Application of Box-Behnken design for optimization of A RP-HPLC method for determination of palonosetron and netupitant in their combined dosage form in presence of their impurities

The use of (Netupitant and Palonosetron) combination to treat nausea and vomiting in cancer chemotherapy patients has been authorized by the Food and Drug Administration. For the simultaneous determination of Netupitant (NET) and palonosetron (PAL) in the presence of two of their related substances and in their dosage form, a sensitive and selective RP-HPLC method has been developed and validated. The aforementioned medications were separated and quantified with the help of experimental design. The Box-Behnken design was used in the experiment to optimize the chromatographic method’s analytical parameters. It employed RP-HPLC with a UV detector. Waters ODS-C18 column (3.5 µm, 75 × 4.6 mm) with a mobile phase composed of acetonitrile: 25 mM phosphate buffer (pH = 3.5) in a gradient mode at 254 nm was employed to separate the cited drugs and their impurities. Palonosetron was linear over the concentration range (1–50 µg/mL) and Netupitant (10–100 µg/mL). According to ICH guidelines, the new method underwent thorough validation. Between the proposed method’s results and those from the reported method, there was no significant difference. It is easy to apply the technique to the analysis of the specified drugs in their combination dosage form for quality control considerations.

A Review of State-of-the-Art on Enabling Additive Manufacturing Processes for Precision Medicine

Abstract Precision medicine is an emerging healthcare delivery approach that considers variability between patients, such as genetic makeups, in contrast to the current one-size-fits-all approach that is designed to treat the average patient. The White House launched the Precision Medicine Initiative in 2015, starting an endeavor to reshape healthcare delivery. To translate the concept of precision medicine from the bench to practice, advanced manufacturing will play an integral part, including the fabrication of personalized drugs and drug delivery devices and drug screening platforms. These products are highly customized and require robust yet flexible manufacturing systems. The advanced manufacturing field has rapidly evolved in the past five years. In this state-of-the-art review, products manufactured for precision medicine will be introduced, followed by a brief review of processing materials and their characteristics. A review on different manufacturing processes applicable to those aforementioned products is provided. The current status of the development of regulatory submission and quality control considerations are also discussed. Finally, this paper presents a future outlook on manufacturing processes used for precision medicine.

Radiopharmaceutical Quality Control Considerations for Accelerator-Produced Actinium Therapies.

Background: Alpha-particle-emitting radiotherapies are of great interest for the treatment of disseminated cancer. Actinium-225 (225Ac) produces four α-particles through its decay and is among the most attractive radionuclides for use in targeted radiotherapy applications. However, supply issues for this isotope have limited availability and increased cost for research and translation. Efforts have focused on accelerator-based methods that produce 225Ac in addition to long-lived 227Ac. Objective: The authors investigated the impact of 225Ac/227Ac material in the radiolabeling and radiopharmaceutical quality control evaluation of a DOTA chelate-conjugated peptide under good manufacturing practices. The authors use an automated module under identical conditions with either generator or accelerator-produced actinium radiolabeling. Methods: The authors have performed characterization of the radiolabeled products, including thin-layer chromatography, high-pressure liquid chromatography, gamma counting, and high-energy resolution gamma spectroscopy. Results: Peptide was radiolabeled and assessed at >95% radiochemical purity with high yields for generator produced 225Ac. The radiolabeling results produced material with subtle but detectable differences when using 225Ac/227Ac. Gamma spectroscopy was able to identify peptide initially labeled with 227Th, and at 100 d for quantification of 225Ac-bearing peptide. Conclusion: Peptides produced using 225Ac/227Ac material may be suitable for translation, but raise new issues that include processing times, logistics, and contaminant detection.

Opportunities and challenges for the use of common controls in sequencing studies.

Genome-wide association studies using large-scale genome and exome sequencing data have become increasingly valuable in identifying associations between genetic variants and disease, transforming basic research and translational medicine. However, this progress has not been equally shared across all people and conditions, in part due to limited resources. Leveraging publicly available sequencing data as external common controls, rather than sequencing new controls for every study, can better allocate resources by augmenting control sample sizes or providing controls where none existed. However, common control studies must be carefully planned and executed as even small differences in sample ascertainment and processing can result in substantial bias. Here, we discuss challenges and opportunities for the robust use of common controls in high-throughput sequencing studies, including study design, quality control and statistical approaches. Thoughtful generation and use of large and valuable genetic sequencing data sets will enable investigation of a broader and more representative set of conditions, environments and genetic ancestries than otherwise possible.

Momordica charantia L.—Diabetes-Related Bioactivities, Quality Control, and Safety Considerations

Momordica charantia L. (Cucurbitaceae), commonly known as bitter gourd or bitter melon, is widely cultivated in many tropical and subtropical regions of the world, where its unripe fruits are eaten as a vegetable. Apart from its culinary use, M. charantia has a long history in traditional medicine, serving as stomachic, laxative or anthelmintic, and, most notably, for the treatment of diabetes and its complications. Its antidiabetic properties and its beneficial effects on blood glucose and lipid concentrations have been reported in numerous in vitro and in vivo studies, but the compounds responsible for the observed effects have not yet been adequately described. Early reports were made for charantin, a mixture of two sterol glucosides, and the polypeptide p-insulin, but their low concentrations in the fruits or their limited bioavailability cannot explain the observed therapeutic effects. Still, for many decades the search for more reasonable active principles was omitted. However, in the last years, research more and more focused on the particular cucurbitane-type triterpenoids abundant in the fruits and other parts of the plant. This mini review deals with compounds isolated from the bitter gourd and discusses their bioactivities in conjunction with eventual antidiabetic or adverse effects. Furthermore, methods for the quality control of bitter gourd fruits and preparations will be evaluated for their meaningfulness and their potential use in the standardization of commercial preparations.

Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform.

Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.

Human Neural Stem Cells for Cell-Based Medicinal Products.

Neural stem cells represent an attractive tool for the development of regenerative therapies and are being tested in clinical trials for several neurological disorders. Human neural stem cells can be isolated from the central nervous system or can be derived in vitro from pluripotent stem cells. Embryonic sources are ethically controversial and other sources are less well characterized and/or inefficient. Recently, isolation of NSC from the cerebrospinal fluid of patients with spina bifida and with intracerebroventricular hemorrhage has been reported. Direct reprogramming may become another alternative if genetic and phenotypic stability of the reprogrammed cells is ensured. Here, we discuss the advantages and disadvantages of available sources of neural stem cells for the production of cell-based therapies for clinical applications. We review available safety and efficacy clinical data and discuss scalability and quality control considerations for manufacturing clinical grade cell products for successful clinical application.

Manufacturing Bacteriophages (Part 2 of 2): Formulation, Analytics and Quality Control Considerations.

Within this second piece of the two-part series of phage manufacturing considerations, we are examining the creation of a drug product from a drug substance in the form of formulation, through to fill-finish. Formulation of a drug product, in the case of bacteriophage products, is often considered only after many choices have been made in the development and manufacture of a drug substance, increasing the final product development timeline and difficulty of achieving necessary performance parameters. As with the preceding review in this sequence, we aim to provide the reader with a framework to be able to consider pharmaceutical development choices for the formulation of a bacteriophage-based drug product. The intent is to sensitize and highlight the tradeoffs that are necessary in the development of a finished drug product, and to be able to take the entire spectrum of tradeoffs into account, starting with early-stage R&D efforts. Furthermore, we are arming the reader with an overview of historical and current analytical methods with a special emphasis on most relevant and most widely available methods. Bacteriophages pose some challenges that are related to but also separate from eukaryotic viruses. Last, but not least, we close this two-part series by briefly discussing quality control (QC) aspects of a bacteriophage-based product, taking into consideration the opportunities and challenges that engineered bacteriophages uniquely present and offer.

Haplotype-resolved de novo assembly of the Vero cell line genome

The Vero cell line is the most used continuous cell line for viral vaccine manufacturing with more than 40 years of accumulated experience in the vaccine industry. Additionally, the Vero cell line has shown a high affinity for infection by MERS-CoV, SARS-CoV, and recently SARS-CoV-2, emerging as an important discovery and screening tool to support the global research and development efforts in this COVID-19 pandemic. However, the lack of a reference genome for the Vero cell line has limited our understanding of host–virus interactions underlying such affinity of the Vero cell towards key emerging pathogens, and more importantly our ability to redesign high-yield vaccine production processes using Vero genome editing. In this paper, we present an annotated highly contiguous 2.9 Gb assembly of the Vero cell genome. In addition, several viral genome insertions, including Adeno-associated virus serotypes 3, 4, 7, and 8, have been identified, giving valuable insights into quality control considerations for cell-based vaccine production systems. Variant calling revealed that, in addition to interferon, chemokines, and caspases-related genes lost their functions. Surprisingly, the ACE2 gene, which was previously identified as the host cell entry receptor for SARS-CoV and SARS-CoV-2, also lost function in the Vero genome due to structural variations.