Applied Biosafety最新文献

The Coronavirus Aid, Relief, and Economic Security (CARES) Act was passed in response to both the global pandemic's immediate negative and expected long-lasting impacts on the economy. Under the Act, mortgage borrowers are allowed to cease making payments if their income was negatively impacted by Covid-19. Importantly, borrowers were not required to demonstrate proof of impaction, either currently or retrospectively. Exploring the economic implications of this policy, this study uses an experimental design to first identify strategic forbearance incidence, and then to quantify where the forborne mortgage payment dollars were spent. Our results suggest strategic mortgage forbearance can be significantly reduced, saving taxpayers billions of dollars in potential losses, simply by requiring a 1-page attestation with lender recourse for borrowers wishing to engage in COVID-19 related mortgage payment cessation programs. Additionally, we demonstrate the use of these forborne mortgage payments range from enhancing the financial safety net for distressed borrowers by increasing precautionary savings, to buying necessities, to equity investing and debt consolidation.

Introduction: We previously reported on the United States' regulatory environment evolving to accommodate an emerging boom in gene therapy research. Several important developments have transpired in the 2 years since that article was published, including the coronavirus disease 2019 (COVID-19) pandemic and the drive for large-scale testing of vaccines containing recombinant or synthetic nucleic acid molecules. This report highlights key developments in the field with a focus on biosafety and issues of note to biosafety professionals with responsibilities over clinical research. Discussion: We provide guidance for performing risk assessments on the currently approved gene therapy products as well as the most utilized types of investigational products in clinical trials. Areas of focus include the prominent approaches utilized in the three major areas of research: oncology, infectious diseases, and rare diseases. Conclusion: The COVID-19 pandemic has created several opportunities for continued growth in gene therapy. National vaccination campaigns will result in greater public acceptance of gene therapy research. Technological advancements that made the vaccine race possible will spur the next generation of research. Advancements born in the developed world set the stage for the creation of therapeutics to treat greater numbers in the developing world and have the potential for massive benefits to global public health. Biosafety professionals and Institutional Biosafety Committees play key roles in contributing to the safe evidence-based advancement of gene therapy research. Biosafety professionals responsible for clinical research oversight must be aware of emerging technologies and their associated risks to support the safe and ethical conduct of research.

Introduction: The emergence of biological threats that can potentially affect millions emphasizes the need to develop a policy framework in the Philippines that can mount an adequate and well-coordinated response. The objective of the study was to assess, strengthen, and harmonize efforts in biorisk management through the development of a National Biorisk Management Framework. Methods: The development of the National Biorisk Management Framework was carried out in two phases: (1) assessment of the current biosafety and biosecurity landscape and (2) framework development. Results: This study identified policy gaps in the incorporation of biosafety in course curricula, professional development, and organizational twinning. The desired policy outcomes focus on increasing the capacity and quality of facilities, and the development of the biosafety officer profession. The tabletop exercises revealed weak implementation of existing protocols and unclear coordination mechanisms for emergency response. Based on these, a framework was drafted composed of eight key areas in biosafety and biosecurity, and four key contexts in risk reduction and management. Discussion and Conclusion: Reforms in biosafety and biosecurity policies are expected to improve coordination, ensure sustainability, capacitate facilities, and professionalize biosafety officers. Because of the complexity of reforms necessary, success will require a consistent and coherent policy framework that (1) provides well-coordinated mechanisms toward harmonized risk reduction and management, (2) establishes and enforces guidelines on biosafety, biosecurity, and biorisk management, (3) regulates facilities essential for occupational safety and public health, and (4) is financed by the General Appropriations Act as part of the national budget.

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.