Applied biosafety : journal of the American Biological Safety Association最新文献

{"title":"Emerging Use of Bacteriophages, Natural Predators of Bacteria, to Combat Antibiotic Resistance in the Clinic and Beyond: A Review of the Field and Biosafety Assessment.","authors":"Paul Gulig, Scott Swindle, Daniel Eisenman","doi":"10.1177/15356760251388486","DOIUrl":"10.1177/15356760251388486","url":null,"abstract":"<p><strong>Introduction: </strong>Bacteriophages (or phages) are viruses that infect and replicate within bacteria. Widespread use of antibiotics during World War II curtailed phage research in the western world. Unfortunately, clinical deployment of antibiotics has led to the prevalence of antibiotic resistance becoming so severe that the World Health Organization (WHO) has warned about the prospect of a postantibiotic world. The WHO is encouraging research into clinical use of bacteriophages as a means of countering antibiotic resistance.</p><p><strong>Methods: </strong>This review summarizes advances in phage research, particularly as it pertains to clinical use. Topics covered include considerations for research and development, genetic engineering, biosafety, One Health (clinical, veterinary, and agricultural use), as well as environmental and regulatory issues.</p><p><strong>Conclusions: </strong>Research and development of phage therapy is a promising avenue for combating the dangerous rise in antibiotic resistance and may eventually become a standard medical countermeasure to complement or replace antibiotics.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"31 1","pages":"4-23"},"PeriodicalIF":0.7,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13098823/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147937052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biosafety Officers and the Prevention of Laboratory Animal Allergy.","authors":"Gregg M Stave, Karen B Byers","doi":"10.1177/15356760251365286","DOIUrl":"10.1177/15356760251365286","url":null,"abstract":"","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"31 1","pages":"1-3"},"PeriodicalIF":0.7,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13098818/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147937043","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transporting Common Vampire Bats (<i>Desmodus rotundus</i>) by Land: Design of a Transport Container and Care During Transit.","authors":"Elsa M Cárdenas-Canales, Mathew C Bohne, Elizabeth A Falendysz, Jorge E Osorio, Tonie E Rocke","doi":"10.1089/apb.2025.0004","DOIUrl":"10.1089/apb.2025.0004","url":null,"abstract":"<p><strong>Introduction: </strong>To comply with biosafety regulations for the transport of wild-caught common vampire bats (Desmodus rotundus) by land from San Luis Potosí, Mexico to Madison, Wisconsin, USA, we designed a unique container that allowed for feeding (with bovine blood) while maintaining a sealed environment and preventing escape of animals or potential sources of infectious materials (e.g., spills, aerosols).</p><p><strong>Methods: </strong>The container was designed by modifying a commercially available mouse transport container and installing a tube/syringe system that allowed delivering and retrieving the blood during the feeding session and cleaning afterward. We transported 93 vampire bats in ten transport containers with no more than ten individuals per container.</p><p><strong>Conclusion: </strong>During transit, the vampire bats acclimated well to the novel environment and were able to access blood during feeding. Although one bat was found dead on arrival, the remaining 92 were transported without complications and deposited at a biosafety level 3 facility once in the U.S.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"31 1","pages":"48-55"},"PeriodicalIF":0.7,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13098819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147937113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Innovation in Personal Protective Equipment Decontamination During the COVID-19 Pandemic: The Powered-Air Purifying Respirator Hood Optimal Decontaminant Distribution System.","authors":"Antony Schwartz, Sarah Mikati, Fred Knipper, Andrea R Vogel, Matthew A Stiegel","doi":"10.1089/apb.2025.0006","DOIUrl":"https://doi.org/10.1089/apb.2025.0006","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic highlighted critical shortages in personal protective equipment (PPE), particularly respirators, which limited healthcare workers' safety worldwide. Decontamination and reuse of PPE, including powered-air purifying respirators (PAPR) hoods, became essential to mitigate shortages. Conventional methods were inadequate for complete decontamination, prompting innovative solutions.</p><p><strong>Objective: </strong>To design and evaluate a novel device, the PAPR Hood Optimal Decontaminant Distribution System (PHODDS), for efficient decontamination of PAPR hoods using hydrogen peroxide vapor, ensuring safety, sustainability, and scalability.</p><p><strong>Methods: </strong>PHODDS was constructed using polyvinyl chloride tubing to facilitate hydrogen peroxide vapor circulation throughout PAPR hoods. Three PAPR models were tested in incremental batches of one, six, 10, and 20 hoods. Biological and chemical indicators (BIs and CIs) were placed in challenging areas to verify decontamination efficacy. Off-gassing of the decontaminant was assessed over 7 days post-decontamination.</p><p><strong>Results: </strong>Conventional decontamination methods failed to achieve full decontamination, as indicated by positive biological indicator growth and lack of chemical indicator color change. In contrast, PHODDS demonstrated consistent 6-log reduction efficacy across hoods and batch sizes, with BIs and CIs yielding negative results. The retention of H₂O₂ was minimal, except in some comfort strips.</p><p><strong>Conclusion: </strong>PHODDS successfully achieved effective decontamination of PAPR hoods, offering a scalable, cost-effective solution for PPE shortages during a pandemic response. It enables safe PPE reuse, potentially supporting pandemic resilience and environmental sustainability.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 4","pages":"306-313"},"PeriodicalIF":0.7,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13000413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147501607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of Risk Factors of Laboratory-acquired Infections in Canada: 2016-2023 Data from the Laboratory Incident Notification Canada Surveillance System.","authors":"Christa Marlène Girincuti, Emily F Tran, Audrey Gauthier, Christine Abalos, Antoinette N Davis, Samuel Bonti-Ankomah","doi":"10.1089/apb.2024.0025","DOIUrl":"https://doi.org/10.1089/apb.2024.0025","url":null,"abstract":"<p><strong>Introduction: </strong>Laboratory-acquired infections (LAIs) remain a significant occupational hazard worldwide, with the potential for public health risks beyond the laboratory. This study examined 2016 to 2023 data from the Laboratory Incident Notification Canada (LINC) surveillance system to identify risk factors associated with LAIs in Canadian laboratories.</p><p><strong>Methods: </strong>LINC incident reports, focusing on LAIs resulting from exposures to human pathogens or toxins, were analyzed. Potential risk factors contributing to LAIs were identified through univariate, bivariate, and multivariate analyses. Logistic regression was used to assess the association between potential risk factors and the incidence of LAIs.</p><p><strong>Results: </strong>Between 2016 and 2023, there were eight LAI exposure incidents that met the inclusion criteria and 354 non-LAI exposure incidents. Bivariate analyses between 10 potential risk factors and LAI occurrence only identified failure of or inadequate personal protective equipment (PPE) to be statistically significantly associated with LAIs (<i>p</i> = 0.027). Regression analysis demonstrated the importance of PPE, where failure of or inadequate PPE was associated with increased odds of LAI (odds ratio = 4.53, 95% confidence interval: 1.07, 19.28), having adjusted for other potential risk factors. The time trend revealed some variance in the total number of affected persons, with a particular peak in 2018.</p><p><strong>Conclusion: </strong>Failure of or inadequate PPE was a significant risk factor for LAIs in Canadian laboratories, thus reinforcing the importance of safety protocol adherence, ongoing training, and targeted interventions to reduce the risk of LAIs.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 4","pages":"296-305"},"PeriodicalIF":0.7,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13000416/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147501612","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biosafety Guidelines for Viral Vector-Based Gene Therapies: A Resource for Healthcare and Pharmacy Professionals.","authors":"Sumit Ghosh, Jill Blind, Allison Fowler, Samantha Parsons, Kembral Nelson, Katie Campbell","doi":"10.1089/apb.2024.0057","DOIUrl":"10.1089/apb.2024.0057","url":null,"abstract":"<p><strong>Introduction: </strong>Viral vector systems are crucial in delivering therapeutic genetic material for gene and cell therapy in clinical settings. With new progress in viral vector-based gene therapies, healthcare professionals and pharmacists must stay informed and apply appropriate biosafety precautions when handling these products. Comprehensive guidelines covering biosafety measures for every viral vector-based gene therapy, including storage, preparation, administration, and disposal, remain scarce. As viral vector-based gene therapy advances rapidly, it is critical to equip healthcare professionals with the expertise to safely manage these agents in a clinical setting.</p><p><strong>Methods: </strong>As gene therapies become more integrated into mainstream medicine, with 43 cell and gene therapy products approved as of 2025, pharmacists, nurses, and caregivers face new safety challenges when handling these therapies. While guidelines such as United States Pharmacopeia (USP) 797 and USP 800 provide a foundation for handling viral vector-based gene therapies, no single resource consolidates all biosafety considerations for healthcare professionals. This review provides an overview of the viral vector-based gene therapy landscape. It compiles best practices from various sources to establish a potential standardized approach to guide safe handling procedures for viral vector systems in a healthcare setting.</p><p><strong>Discussion: </strong>By adopting the biosafety strategies outlined in this article, healthcare staff and pharmacists can safely manage viral vectors while developing standard operating procedures tailored to their specific clinical environments. Implementing these measures will support the continued advancement of gene therapy while ensuring the safety of healthcare providers, patients, and the environment.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 4","pages":"273-295"},"PeriodicalIF":0.7,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13006171/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147518003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using Embodied Artificial Intelligence Agents to Automate Biorisk Management Tasks in High-Containment Laboratories.","authors":"Leyma P De Haro","doi":"10.1089/apb.2024.0068","DOIUrl":"https://doi.org/10.1089/apb.2024.0068","url":null,"abstract":"<p><strong>Background: </strong>Recent advances in synthetic biology have raised new challenges in biosecurity and biorisk management (BRM), particularly in high-containment laboratories and other critical research settings.</p><p><strong>Objective: </strong>This article explores the use of artificial intelligence (AI) agents to automate BRM tasks, thus enhancing both safety and efficiency in these sensitive environments.</p><p><strong>Methods: </strong>We propose an integrated system combining machine learning models for risk assessment with embodied AI agents capable of executing physical containment and other tasks. Specifically, AI algorithms can be employed for predictive risk modeling, anomaly detection, and real-time decision-making, while embodied AI agents can serve to carry out operations that would otherwise expose humans to hazardous biological agents and other hazards.</p><p><strong>Results: </strong>Combined, these two technologies are known as a specialized AI agent for BRM. This dual approach aims to reduce the cognitive and physical burdens on human personnel, minimize human error, and ensure consistent adherence to BRM protocols. This combination optimizes laboratory workflows and introduces a robust layer of redundancy in managing biological risks. Conclusions: Here we present a novel and promising step forward in augmenting the safety of high-containment laboratories through implementation of specialized AI agents; thus, contributing to more resilient BRM frameworks.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 4","pages":"314-325"},"PeriodicalIF":0.7,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13000415/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147501644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding Work-as-Imagined and Work-as-Done in Biomedical Laboratories.","authors":"Viji Vijayan","doi":"10.1089/apb.2025.0012","DOIUrl":"https://doi.org/10.1089/apb.2025.0012","url":null,"abstract":"<p><strong>Introduction: </strong>Gaps between work-as-imagined (WAI) and work-as-done (WAD) have not been studied in biomedical laboratories. WAI takes the form of standard operating procedures (SOPs), and WAD is the way in which work is really done. The workers are often unable to follow the written procedures exactly. They will realise that they have degrees of freedom to perform tasks, and as they get more experienced, they will have more choices based on practice and know-how.</p><p><strong>Methods: </strong>Fifteen workers were interviewed to explore gaps between WAI and WAD. Participants were also asked how they assessed if the deviations they made were able to ensure safety and productivity and the best way to learn safe work in the laboratory.</p><p><strong>Results: </strong>Participants did not always follow the SOPs exactly, which resulted in gaps between WAI and WAD. All participants did a \"on the spot\" mental risk assessment and deviated from SOP based on that. They were able to discern the high-risk steps that they strictly followed. The most common reason for the gaps were work pressure and time constraint, especially in time-sensitive procedures with precious samples and reagents.</p><p><strong>Conclusion: </strong>Concepts like WAI and WAD and the inevitable gaps between them are new in the biomedical laboratories. Such gaps need to be identified, assessed, and addressed to ensure safe work. Organizations need to make safety SOPs relevant and ensure that the workers are consulted when developing SOPs. Some local variability is inevitable, and these skills can be strengthened by open communication and interactive safety training methods.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 4","pages":"326-335"},"PeriodicalIF":0.7,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13000418/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147501649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of Biocontainment Efficacy and Flow Cytometric Impact of a Novel Platform in High Containment Laboratories.","authors":"Melanie Cohen, Julie Laux, Iyadh Douagi","doi":"10.1177/15356760251378149","DOIUrl":"10.1177/15356760251378149","url":null,"abstract":"<p><strong>Introduction: </strong>Flow cytometry remains one of the most central technologies with broad applications in immunology and infectious disease research. In the lack of compatible measures for pathogen inactivation, cytometric analysis of live cells derived from infectious samples classically poses exposure risks to both operators and environment. Enclosing a cell analyzer in a biosafety cabinet (BSC) could significantly improve safety margins for laboratory operations but has unknown impacts on instrument performance. Here, we describe and characterize the performance of a novel, BSC-housed analyzer for cytometric analysis of infectious samples within a biosafety level-3 laboratory.</p><p><strong>Methods: </strong>We investigated internal BSC and ultraviolet (UV) laser temperature over time. System stability was assessed using quality control particles with the BSC on and off. Aerosol generation was tested at four locations in normal and simulated failure modes using fluorescent Dragon Green beads.</p><p><strong>Results: </strong>Under these conditions, the temperature of the BSC and UV laser was stable during operations. The BSC did not significantly impact instrument performance or stability. Low amounts of aerosols were detected from vulnerable points in the system, and 15-fold reduction in aerosol generation was achieved with the introduction of a plate seal.</p><p><strong>Conclusions: </strong>Utilizing a tailored platform for cell analysis in high-containment laboratory, we demonstrate that BSC enclosure of the analyzer preserved operational performance of both units. Aerosol measurement studies revealed the importance of a BSC-contained instrument when investigating infectious samples. Our findings stress the need to accelerate efforts toward the integration of cytometry-based technologies in high-containment laboratories.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":" ","pages":""},"PeriodicalIF":0.7,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13099074/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147795021","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Low-Energy Electron Irradiation Inactivates Viruses in Serum and Maintains Growth-Promoting Properties in Cell Culture.","authors":"Jasmin Fertey, Gustavo R Makert, Philipp Becker, Julia Finkensieper, Sebastian Ulbert","doi":"10.1089/apb.2024.0031","DOIUrl":"10.1089/apb.2024.0031","url":null,"abstract":"<p><strong>Background: </strong>Serum and other blood-derived products are widely used in biomedical and biopharmaceutical processes, especially for the production of vaccines or cell therapeutic applications. To ensure quality and safety, each serum lot undergoes testing for sterility to minimize the risk of disease transmission. A currently performed standard procedure is gamma-irradiation of serum for effectively killing pathogens. However, gamma irradiation can only be performed in highly shielded, specialized facilities. Low-energy electron irradiation (LEEI) is an alternative, Good Manufacturing Practice (GMP) compatible method for sterilizing serum in a standard laboratory environment.</p><p><strong>Results: </strong>We directly compared the sensitivity of viruses belonging to the family of flaviviruses (Zika virus and bovine viral diarrhea virus) and parvoviruses (minute virus of mice) against LEEI in 90% serum or buffer. Although the reduction is more effective in buffer than in serum, the calculated decimal reduction dose values suggest that LEEI can efficiently sterilize serum by inactivating viruses, thereby increasing product safety and extending shelf life. Furthermore, LEEI-treated serum was tested as a supplement in cell culture and showed comparable performance to nonirradiated or gamma-irradiated serum when used for the cultivation of different cell lines.</p><p><strong>Conclusion: </strong>LEEI is able to inactivate viral contaminants in serum and offers significant advantages over gamma irradiation, as no large amounts of radioactivity are generated, on-site irradiation is possible, and space requirements are reduced due to fewer protective measures. These advantages allow the technology to be used in a GMP-compliant irradiation process.</p>","PeriodicalId":520561,"journal":{"name":"Applied biosafety : journal of the American Biological Safety Association","volume":"30 3","pages":"264-271"},"PeriodicalIF":0.7,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12415166/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145031600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}