Applied Biosafety最新文献_第7页

Occupational Exposure Risks When Working with Protein Therapeutics and the Development of a Biologics Banding System. 使用蛋白质疗法时的职业暴露风险和生物制剂贴片系统的开发。

IF 1.5

Applied Biosafety Pub Date : 2021-12-01 Epub Date: 2021-11-24 DOI: 10.1089/apb.2021.0004

Jessica Graham, Hugh Yao, Elise Franklin

{"title":"Occupational Exposure Risks When Working with Protein Therapeutics and the Development of a Biologics Banding System.","authors":"Jessica Graham, Hugh Yao, Elise Franklin","doi":"10.1089/apb.2021.0004","DOIUrl":"https://doi.org/10.1089/apb.2021.0004","url":null,"abstract":"Background: As the pharmaceutical industry advances its understanding of biological processes and how they relate to (the causes and treatments of) disease, many new modalities such as protein therapeutics (PTs) are emerging as breakthrough therapies to treat both rare and common diseases. As PTs become more prevalent, occupational health and safety professionals are challenged with identifying potential occupational exposure risks, health hazards, and assessing best practice recommendations for workers who develop, manufacture, and administer PTs. Methods: To characterize airborne exposures to PTs, we conducted a retrospective analysis of industrial hygiene (IH) data for PTs spanning >15 years. This information was used to support the development of an occupational exposure control banding system designed for and applicable to biologically derived PTs (produced in living cells). Overall, 403 IH samples were evaluated that included exposure data for monoclonal antibodies, fusion proteins, PEGylated proteins, and surrogates. Results: Our evaluation of historical IH PT sample data indicated low exposure potential across manufacturing activities with >99% (400/403) being below an airborne concentration of 1 μg/m3. Processes with the highest potential for airborne exposure included high-energy operations (e.g., homogenization) and maintenance activities (e.g., cleaning and repairs). Conclusion: The observed low exposure potential is expected given that many biological manufacturing activities are closed to maintain product sterility. This evaluation indicated that the banding systems historically utilized for small molecules could benefit from being revisited for PTs.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"26 4","pages":"193-204"},"PeriodicalIF":1.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9134339/pdf/apb.2021.0004.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33443274","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}

引用次数: 4

Management System Approach for Addressing Biosafety and Biosecurity of Emerging Pathogens in a Biosafety Level-3 Core Facility. 在生物安全三级核心设施中解决新病原体生物安全和生物安保问题的管理系统方法。

IF 0.5

Applied Biosafety Pub Date : 2021-12-01 Epub Date: 2021-11-24 DOI: 10.1089/apb.2021.0007

Tessy Joseph

{"title":"Management System Approach for Addressing Biosafety and Biosecurity of Emerging Pathogens in a Biosafety Level-3 Core Facility.","authors":"Tessy Joseph","doi":"10.1089/apb.2021.0007","DOIUrl":"10.1089/apb.2021.0007","url":null,"abstract":"Introduction: The biosafety level-3 (BSL-3) core facility (CF) at Yong Loo Lin School of Medicine (NUS Medicine) in National University of Singapore (NUS) has adopted international standards and guidelines to establish a biorisk management (BRM) system that helps to improve its BRM system and consistently minimize the risks to employees, the public, and the environment to an acceptable level while working with SARS-CoV-2. Methods: When the NUS Medicine BSL-3 CF started its operations, the Occupational Health and Safety Assessment Series 18001:2007 and the CEN Workshop Agreement 15793:2011 guidelines were used to establish its first BRM framework. The BRM framework provided the roadmap of how to organize, systematically manage, and structure the various biorisk programs that was then modified according to International Organization for Standardization 35001:2019 during the coronavirus disease 2019 pandemic in 2020 to address the specific circumstances. Results: Adopting a management system approach allowed BSL-3 CF to efficiently manage its BRM even during unpredicted emerging pandemic situations. It resulted in integrating a risk management process into daily laboratory operations and ongoing identification of hazards, prioritization of risks, and the establishment of risk mitigation measures specific to SARS-CoV-2. In addition, the implementation of a BRM system in the BSL-3 CF has increased biorisk awareness among BSL-3 CF users and encouraged every stakeholder to take ownership of their activities, and continual improvements in mitigation of biorisks. Discussion: This article summarizes the systematic approaches and major elements of the BRM systems adopted by NUS Medicine BSL-3 CF for the implementation of biosafety and biosecurity precautions, and control measures to minimize the risk of research activities using various RG3 biological agents including SARS-CoV-2.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"26 4","pages":"210-220"},"PeriodicalIF":0.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9134332/pdf/apb.2021.0007.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33443275","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}

引用次数: 0

Development and Validation of Biosafety Climate Scale for Biological and Biomedical Science Laboratories in the United States. 美国生物和生物医学科学实验室生物安全气候量表的开发与验证。

IF 1.5

Applied Biosafety Pub Date : 2021-12-01 Epub Date: 2021-11-24 DOI: 10.1089/apb.2021.0006

Sivarchana Mareedu-Boada, Torsten Alwin Hopp, Riten Mitra

{"title":"Development and Validation of Biosafety Climate Scale for Biological and Biomedical Science Laboratories in the United States.","authors":"Sivarchana Mareedu-Boada, Torsten Alwin Hopp, Riten Mitra","doi":"10.1089/apb.2021.0006","DOIUrl":"https://doi.org/10.1089/apb.2021.0006","url":null,"abstract":"Introduction: Industry-specific safety climate scales that measure safety status have been published, however, nothing specific to biological laboratories has ever been established. Objective: This study aimed to develop and validate a biosafety climate (BSCL) scale unique for research professionals (RPs) and biosafety professionals (BPs) at teaching and research biological laboratories affiliated to public universities in the United States. Methods: BSCL scale was developed from literature review. In study 1, 15-item biosafety climate (BSCL-15) scale with 15 items and 5 factors was pretested with n = 9 RPs and n = 7 BPs to perform reliability, content, and face validity analyses. In study 2, revised 17-item biosafety climate (BSCL-17) scale with 17 items and 5 factors was pilot tested with n = 91 RPs and n = 88 BPs. Correlation tests, Kaiser-Mayer-Olkin, Bartlett's test of sphericity, Cronbach's alpha, and exploratory factor analysis (EFA) were conducted to validate the BSCL-17 scale. Results: EFA resulted in a 3-factor 17-item BSCL scale for both RPs and BPs. Internal consistency of the scale was > 0.8 for the BSCL scale and the underlying three factors, indicating high reliability. The factors identified for RPs are 1) management priority, communication and participation, 2) group norms, and 3) supervisor commitment. The factors identified for BPs are 1) management priority and communication, 2) group norms and participation, and 3) supervisor commitment. Discussion: A valid and reliable BSCL scale to measure safety climate and quantify safety culture in biological laboratories has been presented. It can be used as a key performance indicator and aid in targeted interventions as part of process improvement of biological safety programs.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"26 4","pages":"221-231"},"PeriodicalIF":1.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9134341/pdf/apb.2021.0006.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33443849","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}

引用次数: 1

Validation and Application of a Benchtop Cell Sorter in a Biosafety Level 3 Containment Setting. 台式细胞分选器在生物安全3级容器环境中的验证和应用。

IF 1.5

Applied Biosafety Pub Date : 2021-12-01 Epub Date: 2021-11-24 DOI: 10.1089/apb.20.0065

Lydia M Roberts, Rebecca Anderson, Aaron Carmody, Catharine M Bosio

{"title":"Validation and Application of a Benchtop Cell Sorter in a Biosafety Level 3 Containment Setting.","authors":"Lydia M Roberts, Rebecca Anderson, Aaron Carmody, Catharine M Bosio","doi":"10.1089/apb.20.0065","DOIUrl":"https://doi.org/10.1089/apb.20.0065","url":null,"abstract":"Introduction: Fluorescent-activated cell sorting (FACS) is often the most appropriate technique to obtain pure populations of a cell type of interest for downstream analysis. However, aerosol droplets can be generated during the sort, which poses a biosafety risk when working with samples containing risk group 3 pathogens such as Francisella tularensis, Mycobacterium tuberculosis, Yersinia pestis, and severe acute respiratory syndrome coronavirus 2. For many researchers, placing the equipment required for FACS at biosafety level 3 (BSL-3) is often not possible due to expense, space, or expertise available. Methods: We performed aerosol testing as part of the biosafety evaluation of the MACSQuant Tyto, a completely closed, cartridge-based cell sorter. We also established quality control procedures to routinely evaluate instrument performance. Results: The MACSQuant Tyto does not produce aerosols as part of the sort procedure. Discussion: These data serve as guidance for other facilities with containment laboratories wishing to use the MACSQuant Tyto for cell sorting. Potential users should consult with their Institutional Biosafety Committees to perform in-house risk assessments of this equipment. Conclusion: The MACSQuant Tyto can safely be used on the benchtop to sort samples at BSL-3.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"26 4","pages":"205-209"},"PeriodicalIF":1.5,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9134337/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33443273","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}

引用次数: 2

Demographic and Salary Trends of the 2020 Biosafety Workforce. 2020年生物安全劳动力的人口和工资趋势。

IF 1.5

Applied Biosafety Pub Date : 2021-09-01 DOI: 10.1089/apb.20.0066

Jennifer Fletcher, David Gillum, Rebecca Moritz, Antony Schwartz

引用次数: 2

Demystifying the Risk Assessment Process for Laboratory-Based Experiments Utilizing Invasive Genetic Elements: It Is More Than Gene Drive. 揭秘利用侵入性遗传元素的实验室实验的风险评估过程:它不仅仅是基因驱动。

IF 1.5

Applied Biosafety Pub Date : 2021-09-01 DOI: 10.1089/apb.20.0074

Zach N Adelman

{"title":"Demystifying the Risk Assessment Process for Laboratory-Based Experiments Utilizing Invasive Genetic Elements: It Is More Than Gene Drive.","authors":"Zach N Adelman","doi":"10.1089/apb.20.0074","DOIUrl":"https://doi.org/10.1089/apb.20.0074","url":null,"abstract":"Advances in recombinant DNA approaches have resulted in the development of transgene architectures that severely bias their own inheritance, a process commonly referred to as \"gene drive.\" The rapid pace of development, combined with the complexity of many gene drive approaches, threatens to overwhelm those responsible for ensuring its safe use in the laboratory, as even identifying that a specific transgene is capable of gene drive may not be intuitive. Although currently gene drive experiments have been limited to just a few species (mosquitoes, flies, mice, and yeast), the range of organisms used in gene drive research is expected to increase substantially in the coming years. Here the defining features of different gene drive approaches are discussed. Although this will start with a focus on identifying when gene drive could or could not occur, the emphasis will also be on establishing risk profiles based on anticipated level of invasiveness and persistence of transgenes in the surrounding environment. Attention is also called to the fact that transgenes can be considered invasive without being considered gene drive (and vice versa). This further supports the notion that adequate risk assessment requires information regarding the specific circumstances a given transgene or set of transgenes is capable of invading a corresponding population. Finally, challenges in the review and evaluation of work involving gene drive organisms are discussed.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"26 3","pages":"154-163"},"PeriodicalIF":1.5,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9134331/pdf/apb.20.0074.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10622001","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}

引用次数: 1

Applied Biosafety's Special Supplemental Issue on Global Biosafety and Biosecurity Initiatives 《应用生物安全》关于全球生物安全和生物安全倡议的补充特刊

IF 1.5

Applied Biosafety Pub Date : 2021-09-01 DOI: 10.1089/apb.2021.29001.intro

Barbara Johnson, K. Byers, S. Patlovich, David R Gillum

引用次数: 0

Strengthening Medical Laboratory Systems in Kenya: An Innovative Biosafety Training Model. 加强肯尼亚医学实验室系统:一种创新的生物安全培训模式。

IF 1.5

Applied Biosafety Pub Date : 2021-09-01 DOI: 10.1089/apb.20.0072

Doris Bota, Albert Bunyasi, Angela Amayo, Jedida Wangari Wachira, Jacob Onyango Okello

{"title":"Strengthening Medical Laboratory Systems in Kenya: An Innovative Biosafety Training Model.","authors":"Doris Bota, Albert Bunyasi, Angela Amayo, Jedida Wangari Wachira, Jacob Onyango Okello","doi":"10.1089/apb.20.0072","DOIUrl":"https://doi.org/10.1089/apb.20.0072","url":null,"abstract":"Background: With increased rates of laboratory-acquired infections from clinical and research laboratories globally, efforts have been made to improve awareness of modern practices and pursue innovations in biosafety to manage risks and laboratory exposures arising from infectious agents and other hazards. Objectives: This article demonstrates a sustainable biosafety training model developed to enhance laboratory quality and support accreditation in health facilities in Kenya. Methods: A biosafety technical working group was formed, and sensitization meetings held with health managers. Trainings were then conducted for training of trainers (TOTs) who then cascaded trainings in health facilities. This was followed by mentorships and monitoring for implementation. Results: Five sensitization meetings were carried out for 264 health managers. TOTs was done for 48 trained trainers and 1044 laboratory workers in 216 facilities covering 44 counties. Site visits were done in 51 facilities, with biosafety achievements measured in 21 (41%), respectively. Achievements in 21 facilities included the following: improvised eye wash stations in 16 facilities (76%), biological spill kits in 17 (81%), buckets of sand in 15 (71%), fire extinguishers in 12 (57%), hepatitis B vaccination in 14 (66%), establishment of phlebotomy areas in 18 facilities (85%), material safety data sheets in 18 (85%), documentation of incidents and exposures in 16 (76%), and proper waste segregation in 17 (81%). Conclusion: This model ensured rapid scale-up to multiple counties and enabled learners to understand biosafety principles. Due to management buy-in, resources were availed to implement interventions, and this was demonstrated by remarkable achievements across all assessed facilities.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"26 Suppl 1","pages":"S16-S26"},"PeriodicalIF":1.5,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9135156/pdf/apb.20.0072.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10254346","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}

引用次数: 1

Biological Select Agents and Toxins Management in Taiwan: From Past to Present. 台湾生物选择剂与毒素管理:从过去到现在。

IF 1.5

Applied Biosafety Pub Date : 2021-09-01 DOI: 10.1089/apb.19.0045

Li-Chi Hsieh, Wen-Chao Wu, Shu-Hui Tseng

{"title":"Biological Select Agents and Toxins Management in Taiwan: From Past to Present.","authors":"Li-Chi Hsieh, Wen-Chao Wu, Shu-Hui Tseng","doi":"10.1089/apb.19.0045","DOIUrl":"https://doi.org/10.1089/apb.19.0045","url":null,"abstract":"Introduction: Before 2016, there were no specific regulations or guidelines for the management of biological select agents and toxins (BSATs) in Taiwan. The Taiwan Centers for Disease Control responded to the global health security agenda in 2016 and made use of the Joint External Evaluation tool: International Health Regulations to evaluate Taiwan's epidemic prevention system capacities, including BSAT management. For technical areas that did not meet the highest requirements, the regulations and guidelines are now in place to strengthen the management of BSATs. Methods: In 2017, a survey on the BSAT entities management status in Taiwan was conducted to understand the gap between BSAT practice and international policies, and to improve BSAT management based on the findings. Results and Discussion: After 3 years of promotion, relevant management regulations and supervision mechanisms have been established. In 2021, the evaluation will be conducted again and it is expected that Taiwan's BSAT management capacity will reach the level of international biosafety and biosecurity.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"26 3","pages":"123-129"},"PeriodicalIF":1.5,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9134322/pdf/apb.19.0045.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9233650","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}

引用次数: 1

Mechanisms of Sporicidal Activity Induced by Ionized Hydrogen Peroxide in the Spores of Bacillus atrophaeus. 过氧化氢离子诱导萎缩芽孢杆菌孢子杀孢活性的机制。

IF 1.5

Applied Biosafety Pub Date : 2021-09-01 DOI: 10.1089/apb.20.0060

Miguel A Grimaldo, Nicole L Mendell, Nathen E Bopp, Donald H Bouyer, Claudio Mafra

{"title":"Mechanisms of Sporicidal Activity Induced by Ionized Hydrogen Peroxide in the Spores of Bacillus atrophaeus.","authors":"Miguel A Grimaldo, Nicole L Mendell, Nathen E Bopp, Donald H Bouyer, Claudio Mafra","doi":"10.1089/apb.20.0060","DOIUrl":"https://doi.org/10.1089/apb.20.0060","url":null,"abstract":"Introduction: Ionized hydrogen peroxide (iHP) is a new technology used for the decontamination of surfaces or laboratory areas. It utilizes a low concentration of hydrogen peroxide (H2O2) mixed with air and ionized through a cold plasma arc. This technology generates reactive oxygen species as a means of decontamination. Objectives: The purpose of this study is to review the effects of iHP on the structure of the spores of Bacillus atrophaeus by observing its effects using transmission electron microscopy (TEM) and also by evaluating the existence of DNA damage by fluorescence-based quantitative polymerase chain reaction (qPCR). Methods: Spore samples of B. atrophaeus decontaminated using iHP at different exposure times (Control, 1, 2, 6, and 12 h) were fixed for TEM. In addition, DNA was extracted for evaluation of DNA damages using fluorescence-based qPCR assays. Results: Damages to the spore structures of B. atrophaeus caused by the decontamination process with iHP at different exposure times (Control, 1, 2, 6, and 12 h) can be observed in micrographs. The effects of the decontamination to short DNA segment (132 base pairs [bp]) of the yaaH gene using qPCR present a linear degradation, and for the long DNA segment (680 bp), it presents a biphasic mode. Conclusion: The results of the qPCR analysis show two initial stages of damage to DNA with very noticeable damage at 12 h contact time, which confirms the observations of the TEM micrographs for the B. atrophaeus spores. The study demonstrates damage to the spore core DNA.","PeriodicalId":7962,"journal":{"name":"Applied Biosafety","volume":"26 3","pages":"130-138"},"PeriodicalIF":1.5,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9134323/pdf/apb.20.0060.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10248473","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}

引用次数: 0