Good Manufacturing Practice Research Articles

A RELEVÂNCIA DOS PROGRAMAS DE AUTOCONTROLE NA SAÚDE PÚBLICA EM INDÚSTRIAS DE PRODUTOS DE ORIGEM ANIMAL

Self-Control Programs (PACs) are fundamental for the agroindustry, aiming at food safety and reducing risks to public health. Along with Good Manufacturing Practices (GMP), Standard Operational Hygiene Procedures (PPHO) and the Hazard Analysis and Critical Control Points Program (HACCP). The research aims to demonstrate the importance of PAC as a tool capable of minimizing and controlling levels of contamination, infection and/or food poisoning in the food industry, discussing the regulations issued by supervisory authorities on the quality, health and safety of food, as well as good practices in the production of products of animal origin. The importance of studying this topic is that it has great relevance due to the fact that it addresses the importance of the hygienic-sanitary and technological quality of raw materials, animal health and public health. The study was carried out using articles, books and academic sources through electronic searches in SciELO, Google Scholar, PUBMED, PubVet of relevance in addition to Laws and books, bibliographical research and insights into the need to highlight and demonstrate the importance of programs in the food industry. It was concluded that PACs are essential to reduce risks to public health and enhance food quality and safety for consumers.

Upgrading of Quality Control for Herbal Medicine Use in South Korea by Introducing an Accreditation System: a brief report.

This study aimed to present a government-led accreditation system for upgrading the quality control of herbal medicine by introducing the process and evaluation standard of external herbal dispensaries (EHDs) of traditional Korean medicine (TKM) clinics in South Korea 2018 to refer to other countries where herbal medicine were used similarly in Korea. We organized an EHD accreditation committee for the establishment of an accreditation system. The committee consisted of 9 experts an official of the Ministry of Health and Welfare (MoHW), a professor expert of TKM, a good manufacturing practice expert, a hazard analysis and critical control point expert, and an accreditation system expert. After 3 meetings, a draft of the evaluation standard and evaluation system was established in 2017. Based on the draft, a pilot test was conducted to determine the applicability of the evaluation standards in 2017. Two additional meeting was held to confirm the accreditation standards and was finalized in 2018. The evaluation standard for EHDs was developed. In the case of herbal medicine EHDs, the evaluation standard consisted of 9 evaluation categories, 25 evaluation parts, and 81 evaluation items were developed. The results of the evaluation of the pilot tests are as follows, and the results show that there is a deviation between the EHDs. As a world's first, Korea MoHW successfully launched the accreditation system for upgrading the quality control system of herbal medicine not approved by Korea's Ministry of Food and Drug Safety in 2018. Our report hope to provide a good reference to other countries where having similar herbal medicine system in South Korea hoping to make better quality control of herbal medicines.

Innovative risk management techniques in food safety: A review of best practices and emerging trends

Effective risk management in food safety is critical to ensuring consumer protection and maintaining the integrity of global food supply chains. Traditional approaches, such as Hazard Analysis and Critical Control Points (HACCP) and Good Manufacturing Practices (GMP), have long been the foundation of food safety risk management. However, with the increasing complexity of food production and distribution, new challenges demand more advanced techniques. This review explores innovative risk management methods, focusing on best practices and emerging trends that are transforming food safety. Technological advancements are driving much of this innovation. Predictive analytics and machine learning now allow for real-time monitoring and hazard detection, improving the accuracy of risk assessments. Blockchain technology is being leveraged for enhanced traceability and transparency in the supply chain, ensuring faster recall management and improved accountability. The integration of IoT (Internet of Things) sensors provides continuous monitoring of environmental factors like temperature and humidity, which are critical in preventing contamination, especially in perishable goods. Additionally, risk-based inspection systems, supported by regulatory frameworks such as the Food Safety Modernization Act (FSMA), are becoming more prevalent, prioritizing resources where risks are highest. Emerging trends such as artificial intelligence (AI) for predictive risk management, big data analytics, and sustainability-driven risk approaches are reshaping the landscape. These innovations not only enhance risk mitigation but also align with consumer demands for greater transparency and environmental responsibility. Despite challenges such as cost, data privacy, and regulatory hurdles, the future of food safety lies in the continued development and adoption of these advanced techniques. This review highlights the potential of these innovative practices to improve food safety standards and protect public health in an increasingly interconnected world. Keywords: Innovative, Risk Management, Food Safety, Review.

Navigating the Regulatory Maze: The Vital Role of Regulatory Affairs in Pharmaceutical Safety and Quality

The real struggle of pharmaceutical industries for survival lies in performing processes by following the guidelines of various regulatory authorities around the globe to provide assured quality of the process under regulations [1]. A profession under-regulated industry, such as that controlling pharmaceuticals, medical devices, energy, and banking, is called Regulatory Affairs (RA) [2]. They may involve minor or major multinational corporations, including innovative biotechnology companies, which have a specific meaning and a separate specialized depart-ment of RA professionals. This department helps to guide the company on the regional and global laws and regulations set forth by different regulatory authorities and helps safeguard the products’ life cycle. The purpose of regulatory departments or pro-fessionals is to develop and promote heavily controlled therapeutic or pharmaceutical goods and build a platform for marketing approval. In addition to this, RA in the pharmaceutical industry is comparatively a new field to safeguard public well-being by monitoring the safety and efficacy of the products [3]. Furthermore, in the late 1950s, multiple tragedies resulted in an increase in legislation for pharmaceutical goods’ quality, safety, and efficacy. As a part of this, strict norms were made for Marketing Authorization (MA) and Good Manufacturing Practice (GMP) [4]. These tragedies included (i) sulphanilamide elixir; (ii) vac-cine tragedy; and (iii) thalidomide tragedy [4]. The present article covers the regulatory affairs’ responsibilities and importance in the context of pharmaceutical industries.

Suspected poor-quality medicines in Kenya: a retrospective descriptive study of medicine quality-related complaints reports in Kenya’s pharmacovigilance database

Poor-quality, substandard and falsified, medicines pose a significant public health threat, particularly in low-middle-income countries. A retrospective study was performed on Kenya's Pharmacovigilance Electronic Reporting System (2014–2021) to characterize medicine quality-related complaints and identify associations using disproportionality analysis. A total of 2767 individual case safety reports were identified, categorized into medicines with quality defects (52.1%), suspected therapeutic failure (41.6%), and suspected adverse drug reactions (6.3%). Predominantly reported were antineoplastic agents (28.6%), antivirals (11.7%), and antibacterial agents (10.8%) potentially linked to non-adherence to good manufacturing practices, inappropriate usage and supply chain degradation. Notably, analgesics (8.2%), and medical devices (3.5%) notified had quality defects, predominantly from government health facilities (60.0%). Antineoplastic agents (20.2%) and antivirals (3.7%) were frequently reported from suspected therapeutic failures and suspected adverse drug reactions, respectively, across both private for-profit facilities (26.5%) and not-for-profit facilities (5.4%). Underreporting occurred in unlicensed health facilities (8.1%), due to unawareness and reporting challenges. Pharmacists (46.1%), and pharmaceutical technicians (11.7%) predominantly reported quality defects, while medical doctors (28.0%) reported suspected therapeutic failures. Orally administered generic medicines (76.9%) were commonly reported, with tablets (5.8%) identified as potential sources of suspected adverse drug reactions, while quality defects were notified from oral solutions, suspensions, and syrups (7.0%) and medical devices (3.9%). The COVID-19 pandemic correlated with reduced reporting possibly due to prioritization of health surveillance. This study provides valuable evidence to supporting the use of medicine quality-related complaints for proactive, targeted regulatory control of high-risk medicines on the market. This approach can be strengthened by employing standardized terminology to prioritize monitoring of commonly reported suspected poor-quality medicines for risk-based sampling and testing within the supply chain.

Multidrug-Resistant Proteus mirabilis and Other Gram-Negative Species Isolated from Native Egyptian Chicken Carcasses.

Poultry carcasses may be reservoirs for the zoonotic transmission of antimicrobial-resistant bacteria to humans and pose a major public health hazard. During the isolation of Salmonella from poultry and other foods, many of the presumptive typical Salmonella colonies on xylose lysine deoxycholate (XLD) agar were found to lack the invA gene, which is the specific target gene for Salmonella spp. Therefore, the current study aimed to estimate the prevalence and antimicrobial resistance profiles of extensively drug-resistant invA-negative non-Salmonella isolates recovered from native Egyptian chicken carcasses as presumptive Salmonella colonies on XLD agar. The non-Salmonella isolates were detected in 84% (126/150) of the examined native Egyptian chicken carcasses and classified into five genera, with prevalence rates of 64% (96/150), 14% (21/150), 6.7% (10/150), 3.3% (5/150), and 1.3% (2/150) for Proteus, Citrobacter, Shigella, Pseudomonas, and Edwardsiella, respectively. One hundred and ninety-five invA-negative, non-verified presumptive Salmonella isolates were recovered and classified at the species level into Proteus mirabilis (132/195; 67.7%), Proteus vulgaris (11/195; 5.6%), Citrobacter freundii (26/195; 13.3%), Shigella flexneri (8/195; 4.1%), Shigella sonnei (6/195; 3.1%), Shigella dysenteriae (3/195; 1.5%), Pseudomonas fluorescens (6/195; 3.1%), and Edwardsiella tarda (3/195; 1.5%). All (195/195; 100%) of these isolates showed resistance against cefaclor and fosfomycin. Additionally, these isolates showed high resistance rates of 98%, 92.8%, 89.7%, 89.2%, 89.2%, 86.7%, 80%, 78.5%, 74.4%, and 73.9% against cephalothin, azithromycin, vancomycin, nalidixic acid, tetracycline, sulfamethoxazole/trimethoprim, cefepime, gentamicin, cefotaxime, and ciprofloxacin, respectively. Interestingly, all (195/195; 100%) of the identified isolates were resistant to at least five antibiotics and exhibited an average MAR (multiple antibiotic resistance) index of 0.783. Furthermore, 73.9% of the examined isolates were classified as extensively drug-resistant, with an MAR index equal to 0.830. The high prevalence of extensively drug-resistant foodborne Proteus, Citrobacter, Shigella, Pseudomonas, and Edwardsiella isolated from native chicken carcasses poses a great hazard to public health and necessitates more monitoring and concern about the overuse and misuse of antibiotics in humans and animals. This study also recommends the strict implementation of GHP (good hygienic practices) and GMP (good manufacturing practices) in the chicken meat supply chain to protect consumer health.

Salmonella in black pepper (Piper nigrum): From farm to processing

Contamination of black pepper (Piper nigrum) with Salmonella is a frequent problem in retail and imported shipments. However, there is scarce information about the prevalence of the pathogen in the initial stages of black pepper production chain. This study sought to bridge this gap in research by determining the prevalence, as well as quantifying, and identifying the main Salmonella serovars present during black pepper primary production and processing. Black pepper (233) and environmental (175) samples were collected from farms (354) and processing plants (54) in Espirito Santo, Brazil. The pathogen was detected in soil (16.7 %), drying waste (20.4 %), fallen berries (3.7 %), threshed berries (14.3 %), and dried peppercorns (22.2 %) collected from farms. Salmonella was also detected in samples of raw material (11.1 %), export products (16.7 %), and processing waste (16.7 %) collected from processing plants. A total of 12 serotypes were identified, and Salmonella Javiana showed the highest prevalence (38.8 %). According to the results, contamination occurring in the post-harvest phase is not eliminated or reduced during processing. Therefore, the adoption of good agricultural and manufacturing practices, supported by hazard analysis and critical control points (HACCP), is crucial to mitigate this kind of contamination. These practices should be combined with decontamination treatments to ensure the safety of the final product.

Assessment of bacterial and fungal contamination of herbal mixture vended within Kaduna metropolis, Nigeria

The consumption of herbal mixtures among Nigerians have been on the increase in recent years. Many herbal mixtures sold to the general public are likely to be contaminated by a diverse range of potentially pathogenic microorganisms due to lack of good manufacturing practices (GMPs). Therefore, this study is aimed to evaluate the bacterial and fungal profile of herbal mixtures sold within the Kaduna metropolis. A total of twenty samples of herbal mixtures were randomly purchased fromfour distinct locations within the Kaduna metropolis. The samples were subjected to microbiological analysis using standard methods. Bacterial genera isolated from the herbal mixture samples include Bacillus sp., Staphylococcus sp., Streptococcus sp. while the fungal genera were Aspergillus sp., Saccharomyces sp., Fusarium sp. and Penicillium sp. Herbal mixture obtained from Mandao and Malali district had the highest (9.68±1.70×105CFU/ml) and lowest (6.60±0.43×105CFU/ml) bacterial load while the corresponding fungal load involved samples obtained from Central market (1.48±11.25×104 CFU/ml) and Tudun Wada (1.48± 3.11 ×103 CFU/ml), respectively. Bacillus sp. (60%) and Aspergillus sp. (45%) were the dominant bacterial and fungal genera, respectively. Given the substantial microbial contamination of herbal mixtures and the potential pathogenicity of certain isolates, it is imperative to ensure that herbalists are wellinformed about the principles and implementation of GMPs. It is recommended that regular microbiological monitoring of herbal mixtures should be conducted.

Microbiological Quality of Coconut Water Sold in the Grande Vitória Region, Brazil, and Phenogenotypic Antimicrobial Resistance of Associated Enterobacteria.

This study aimed to evaluate the microbiological quality of coconut water sold from street carts equipped with cooling coils or refrigerated at bakeries in the Grande Vitória Region, Brazil. Additionally, it assessed the phenotypic and genotypic antimicrobial resistance profiles of isolated enterobacteria. The results indicated that coconut water sold at street carts had lower microbiological quality compared to refrigerated samples, as evidenced by significantly higher counts of mesophilic microorganisms. Using MALDI-TOF, the following opportunistic pathogens were identified: Citrobacter freundii, Enterobacter bugandensis, E. kobei, E. roggenkampii, Klebsiella pneumoniae, and Kluyvera ascorbata. Three isolates-E. bugandensis, K. pneumoniae, and K. ascorbata-were classified as multidrug-resistant (MDR). Widespread resistance to β-lactams and cephalosporins was detected, and some isolates were resistant to quinolones, nitrofurans, and phosphonic acids. The gene blaCTX-M-2 was detected in C. freundii, E. bugandensis, E. kobei, and K. ascorbata. However, genes blaNDM, blaKPC, blaCMY-1, and blaCMY-2 were not detected in any isolate. The findings underscore the need to enhance good manufacturing practices in this sector to control the spread of antimicrobial resistance (AMR). To our knowledge, this is the first study documenting the presence of potentially pathogenic enterobacteria in coconut water samples and their associated phenotypic and genotypic AMR profiles.

Green pharma supply chain: a review of existing practices and future directions

PurposeThe pharmaceutical industry is facing significant pressure to tackle antimicrobial resistance (AMR). Other ecological, societal and regulatory pressures are also driving the industry to “go green”. While such a (green) transition could be possible through appropriate green practices’ implementation, the present understanding about it is superficial and vague. A key reason is the lack of green practices’-related studies on pharmaceuticals, which are also insufficiently comprehensive. This knowledge gap is sought to be addressed.Design/methodology/approachA systematic literature review (SLR) was conducted with 73 carefully selected articles, then subjected to thematic content analyses for synthesising the relevant themes and sub-themes.FindingsAround 76 operational-level green practices covering all key stakeholders across the drug lifecycle were identified. It was revealed that designing drugs having accelerated environmental degradability is important to combat AMR. Also, redesigning existing drugs is environmentally more resource-intensive than developing new ones with significant cost-saving potential in solvent recycling and flexible manufacturing, both of which are not common at present. With regards to green-related barriers, stringent quality requirements on drugs (and therefore risks in making relevant green-oriented modifications) and time-consuming and costly regulatory approvals were found to be the key ones.Practical implicationsThe operational green practices’ framework developed for individual pharmaceutical supply chain stakeholders could help practitioners in benchmarking, modifying and ultimately, adopting green practices. The findings could also assist policymakers in reframing existing regulations, such as Good Manufacturing Practices or GMP-related, to promote greener drug development.Originality/valueThis work is the first systematic attempt to identify and categorise operational-level green supply chain practices across stakeholders in the pharmaceutical sector.Highlights•Biodegradability of drugs is more important than environmental degradability.•Flexible manufacturing process design (or quality by design) reduces resource wastage.•Ecopharmacovigilance is effective in combating PIE and AMR-related issues.•Upstream and downstream coordination is key to greening pharma operations.•Costly and time-consuming regulatory approval is a key barrier to greening pharma processes.

A Comprehensive Review on Studying and Developing Guidelines to Standardize the Inspection of Properties and Production Methods for Mycelium-Bound Composites in Bio-Based Building Material Applications.

Mycelium-bound composites (MBCs) represent a promising advancement in bio-based building materials, offering sustainable alternatives for engineering and construction applications. This review provides a comprehensive overview of the current research landscape, production methodologies, and standardization ideas related to MBCs. A basic search on Scopus revealed over 250 publications on MBCs between 2020 and 2024, with more than 30% focusing on engineering and materials science. Key studies have investigated the physical and mechanical properties of MBCs, optimizing parameters such as substrate type, fungal species, incubation time, and post-processing to enhance material performance. Standardizing the inspection of MBC properties is crucial for ensuring quality and reliability. Various testing standards, including those from the American Society for Testing and Materials (ASTM), the International Organization for Standardization (ISO), the Japanese Industrial Standard (JIS), European Standards (EN), Deutsches Institut für Normung (DIN), and the Thai Industrial Standards Institute (TIS), are utilized to evaluate density, water absorption, compression strength, tensile strength, insulation, and other critical properties. This review highlights the distinction between lab-scale and apply-scale testing methodologies, emphasizing the need for comprehensive evaluation protocols. Additionally, the production process of MBCs involves critical steps like substrate preparation, fungal species selection, and mycelium growth, necessitating the implementation of good manufacturing practices (GMPs) to ensure consistency and quality. The internal and external structures of MBCs significantly influence their performance, necessitating standardized inspection methods using advanced techniques such as scanning electron microscopy (SEM), X-ray computed tomography (CT) scanning, and surface profilometry. By establishing robust inspection protocols and production standards, the industry can enhance the reliability and adoption of MBCs, contributing to innovations in materials science and promoting environmental sustainability. This review underscores the importance of interdisciplinary collaboration, advanced characterization tools, and regulatory frameworks to address challenges and advance the field of MBCs.

Pharmacopeial parametric release strategy in microbiological quality control of radiopharmaceuticals

Nuclear medicine is used to assess body functionality at various levels of biological organization and is increasingly employed for both diagnostic and therapeutic purposes. Nearly 5% of radiopharmaceuticals are used therapeutically, whereas approximately 95% are used for diagnosis. Diagnostic radiopharmaceuticals are generally considered safe because they are administered in subpharmacological doses, and the radiotracer components are employed in minimal doses. Consequently, the radiation exposure to the body during nuclear medicine investigations is typically low. However, when radiopharmaceuticals are used for therapeutic applications such as tumor ablation and bone pain palliation, the emitted radiation is highly localized and potent. Radiotracers and radiation doses are more carefully selected for young patients, as the radiation-induced risk of adverse health effects is greater in children than in adults. Radiopharmaceutical preparations should adhere to the established standards of pharmacopoeia worldwide to ensure safety and efficacy. Adherence to current good manufacturing practices, sterility, and good radiation practices are prerequisites for ensuring effective quality assurance and quality control systems during radiopharmaceutical preparation. The quality control test parameter for radiopharmaceuticals primarily involves physicochemical and biological tests. However, significant concerns exist regarding the biological testing of radiopharmaceuticals, necessitating their parametric release. The time-intensive traditional sterility test, bacterial endotoxin test, and rabbit pyrogen tests have been critical quality control issues due to the short half-lives of most radiopharmaceuticals, as they should be dispensed at the earliest to ensure optimal diagnostic/therapeutic benefit. Therefore, manufacturers of radiopharmaceuticals, dispensers, and nuclear medicine specialists should be cognizant of the issues posed by biological quality control as a primary obstacle to ensuring consistent quality through parametric release from a compendial test method standpoint.

Regression of renal cell carcinoma by T cell receptor-engineered T cells targeting a human endogenous retrovirus

BackgroundWe discovered a novel human endogenous retrovirus (CT-RCC HERV-E) that was selectively expressed in most clear cell renal cell carcinomas (ccRCC) and served as a source of antigens for T...

GMP-compliant automated radiosynthesis of [18F] SynVesT-1 for PET imaging of synaptic vesicle glycoprotein 2 A (SV2A)

BackgroundA novel positron emission tomography (PET) imaging tracer, [18F] SynVesT-1, targeting synaptic vesicle glycoprotein 2 (SV2A), has been developed to meet clinical demand. Utilizing the Trasis AllinOne-36 (AIO) module, we’ve automated synthesis to Good Manufacturing Practice (GMP) standards, ensuring sterile, pyrogen-free production. The fully GMP-compliant robust synthesis of [18F] SynVesT-1 boosting reliability and introducing a significant degree of simplicity and its comprehensive validation for routine human use.Results[18F] SynVesT-1 was synthesized by small modifications to the original [18F] SynVesT-1 synthesis protocol to better fit AIO module using an in-house designed cassette and sequence. With a relatively small precursor load of 5 mg, [18F] SynVesT-1 was obtained with consistently high radiochemical yields (RCY) of 20.6 ± 1.2% (the decay-corrected RCY, n = 3) at end of synthesis. Each of the final formulated batches demonstrated radiochemical purity (RCP) and enantiomeric purity surpassing 99%. The entire synthesis process was completed within a timeframe of 80 min (75 ± 3.1 min, n = 3), saves 11 min compared to reported GMP automated synthesis procedures. The in-human PET imaging of total body PET/CT and time-of-flight (TOF) PET/MR showed that [18F] SynVesT-1 is an excellent tracer for SV2A. It is advantageous for decentralized promotion and application in multi-center studies.ConclusionThe use of AIO synthesizer maintains high production yields and increases reliability, reduces production time and allows rapid training of production staff. Besides, the as-prepared [18F] SynVesT-1 displays excellent in vivo binding properties in humans and holds great potential for the imaging and quantification of synaptic density in vivo.

Evaluasi Penerapan Good Manufacturing Practices Produk Minuman Botanikal Jahe Siap Minum di PT XYZ

<p><strong>In improving the quality of food products as an effort to build a competitive UMKM economic structure, it’s necessary to implement Good Manufacturing Practices to produce the quality and suitable for consumption products. GMP is used as a general reference for food industries which is designed to prevent problems related to the quality and safety of food products. The aim of this research was to evaluated the implementation of GMP for Ginger Botanical Drink product which includes 18 aspects of assessment based on the Minister of Industry's regulation regarding GMP. This research was conducted in a qualitative descriptive. The 11 respondents were employees in the management and production departments with the instruments were field observation and interview on each aspect of GMP parameters. The result of this research showed that GMP implementation at PT XYZ is classified as Level 3 with some non-conformities, there were 2 points in the mayor category from the building aspect, 2 points in the mayor category from the sanitation facilities aspect, 1 point in the mayor category and 1 point in the critical category from the machine and equipment aspect, 1 point in the mayor category from the final product aspect, 1 point in the critical category from the employee aspect, and 1 point in the mayor category from the storage aspect. This proves that the implementation of GMP at PT XYZ is still not good enough, therefore, several improvement recommendations need to be given.</strong></p><p><strong><em>Keywords </em></strong>- <em>Evaluation, GMP, Improvement Recommendations, UMKM</em><em>.</em></p>

Pharmaceutical Inspection Co-operation Scheme: An Overview.

To address the challenges posed by the globalization of regulatory agencies, it is essential to harmonize regulatory requirements, assess Good Manufacturing Practice (GMP) compliance, license production facilities, manage product recalls, and improve information exchange. The Pharmaceutical Inspection Co-operation Scheme (PIC/S) provides a robust framework for tackling these global issues. Through the PIC/S GMP Forum, PIC/S facilitates informal interactions among non-member authorities, professionals, and various organizations with the Committee, fostering networking and collaboration. Furthermore, PIC/S has developed a comprehensive guide on GMP requirements for inspectorates and organizations, ensuring consistent standards across borders. The scheme collaborates with other organizations to enhance and complement collective efforts. With 56 countries involved in PIC/S, whether as members or through the Accession and Pre-Accession Process, the exchange of inspection reports among authorities verifies compliance with PIC/S standards, leading to fewer and more targeted inspections and reducing redundancy. This study's purpose is to establish uniform GMP standards by providing extensive training for inspectors and promoting collaboration and networking among regional and international bodies, regulatory authorities, and other relevant organizations. This approach seeks to build trust in inspections, optimize resource use, and foster a more efficient regulatory environment. Through these efforts, PIC/S continues to play a pivotal role in advancing global pharmaceutical regulatory practices.

Mycotoxins in Fish Production and Impact on Fish Health

The aim of this review is to provide an assessment of mycotoxin contamination in fish feed. Focusing on major mycotoxins including aflatoxins, fumonisins, ochratoxins, trichothecenes, and zearalenone, the paper explores their diverse impacts on fish health, from growth inhibition to immunosuppression. It meticulously examines the sources of mycotoxin contamination in fish feed, addressing raw ingredients, storage conditions, and feed manufacturing processes. The review emphasizes the critical role of adherence to Good Agricultural Practices (GAP) and Good Manufacturing Practices (GMP) in preventing mycotoxin risks. Additionally, the paper elucidates mitigation strategies, encompassing the use of mycotoxin-binding feed additives, feed formulation optimization, and technological advancements for early detection. This comprehensive overview serves as a valuable resource for aquaculture practitioners, researchers, and policymakers aiming to enhance the safety and sustainability of fish production amidst mycotoxin challenges.

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

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

Prevention of Transition from Acute Kidney Injury to Chronic Kidney Disease Using Clinical-Grade Perinatal Stem Cells in Non-Clinical Study.

Acute kidney injury (AKI) is widely recognized as a precursor to the onset or rapid progression of chronic kidney disease (CKD). However, there is currently no effective treatment available for AKI, underscoring the urgent need for the development of new strategies to improve kidney function. Human placental mesenchymal stromal cells (hpMSCs) were isolated from donor placentas, cultured, and characterized with regard to yield, viability, flow cytometry, and potency. To mimic AKI and its progression to CKD in a rat model, a dedicated sensitive non-clinical bilateral kidney ischemia-reperfusion injury (IRI) model was utilized. The experimental group received 3 × 105 hpMSCs into each kidney, while the control group received IRI and saline and the untreated group received IRI only. Urine, serum, and kidney tissue samples were collected over a period of 28 days. The hpMSCs exhibited consistent yields, viability, and expression of mesenchymal lineage markers, and were also shown to suppress T cell proliferation in a dose-dependent manner. To ensure optimal donor selection, manufacturing optimization, and rigorous quality control, the rigorous Good Manufacturing Practice (GMP) conditions were utilized. The results indicated that hpMSCs increased rat survival rates and improved kidney function by decreasing serum creatinine, urea, potassium, and fractionated potassium levels. Furthermore, the study demonstrated that hpMSCs can prevent the initial stages of kidney structural fibrosis and improve kidney function in the early stages by mitigating late interstitial fibrosis and tubular atrophy. Additionally, a robust manufacturing process with consistent technical parameters was established.

Improvement of the Chemical Quality of Cachaça

The objective of this study was to determine the chemical composition of sugarcane spirits and commercial Cachaças, comparing them with the limits established by national legislation and with studies conducted in previous periods. Previous studies have shown that 50% of the samples of this distillate were above the contaminant limits allowed by national legislation, constituting one of the main factors responsible for the low volume of exports. In this research, 531 Cachaça samples were analyzed in order to verify whether they complied with the limits of contaminants and volatile compounds required by Brazilian legislation. The results obtained indicate that Brazilian producers have adapted to the use of good manufacturing practices during the production process, ensuring the standardization of this distilled beverage and consequent compliance with legislation.