Applied Biosafety最新文献

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.

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.

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.

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.

Introduction: This study attempts to understand the demographics and salaries of the biosafety workforce worldwide. It builds upon previous surveys of biosafety professionals. Methods: Using multiple regression, this study explored what factors significantly predict salary. Moreover, this study examined whether significant differences existed regarding salary. These differences were analyzed in isolation (i.e., the variable itself) and while controlling for the variables that predicted salary. Results: In this article, eight factors significantly predicted salary: right-to-work state first, biosafety certifications, place of employment, data entry responsibilities, percentage of biosafety job responsibilities, number of direct reports, level of education, and finally the cumulative years of experience in the field. Discussion: This study highlighted certain trends that have remained consistent and new trends that have emerged over time. This research had increased international participation as compared with previous studies.

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.

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.

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.

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.