Applied Biosafety最新文献

Introduction: This article will review the processes utilized to develop simple effective containment engineering controls. Short-Term Use Biocontainment Bubbles-Yale (STUBB-Ys), as Yale refers to them, were designed, built, tested, and implemented to protect members of the Yale University community from exposure to SARS-CoV-2 aerosols. STUBB-Ys were designed and created in conjunction with end users, constructed by Environmental Health and Safety (EHS) or partner groups, and tested onsite after installation to verify effective operation and containment.

Methods: A wide variety of devices in different settings were developed and installed. STUBB-Ys were used at COVID-19 indoor test centers, laboratories, and clinics. The devices were pursued to create infection prevention measures where existing processes could not be utilized or were inadequate. Each STUBB-Y was tested with a C-Breeze Condensed Moisture Airflow Visualizer to generate smoke and a Fluke 985 Particle Counter, which gives the particle counts from 0.3 to 10 μm to measure particle escape visually and quantitatively. Airflow rates were also tested where applicable with a TSI VelociCalc 9525 Air Velocity Meter.

Results: Students and faculty were able to safely continue vital research or clinical study in the targeted areas with the addition of these simple containment devices to confine aerosols.

Conclusion: From a biorisk management point of view, EHS was able to confine aerosols at their potential source using simple designs and equipment and adhering to the hierarchy of controls. This article demonstrates how a straightforward design process can be used to enhance worker protection during a pandemic.

Introduction: With the burgeoning growth of the gene therapy industry, the Food and Drug Administration (FDA) has produced various guidance documents intended to help gene therapy manufacturers design their preclinical testing and clinical trials to facilitate the process of obtaining marketing approval.

Discussion: Biosafety professionals and institutional biosafety committees (IBCs) with oversight of clinical trials or biopharmaceutical manufacturing stand to benefit from understanding how these guidance documents set the standard for writing the clinical research protocols that are reviewed by IBCs. Although the FDA guidance documents are typically meant for manufacturers (either pharmaceutical companies serving as research sponsors or investigators at academic institutions), much of the content is useful for biosafety professionals and IBCs during the IBC review process.

Conclusion: This article specifically addresses guidance documents pertaining to gene therapy vectors capable of genomic integration, testing for replication competent retrovirus, genome editing, and long-term follow-up of research subjects.

Introduction: Healthcare organizations faced unique operational challenges during the COVID-19 pandemic. Assuring the safety of both patients and healthcare workers in hospitals has been the primary focus during the COVID-19 pandemic.

Methods: The NIH Vaccine Program (VP) with the Vaccine Management System (VMS) was created based on the commitment of NIH leadership, program leadership, the development team, and the program team; defining Key Performance Indicators (KPIs) of the VP and the VMS; and the NIH Clinical Center's (NIH CC) interdisciplinary approach to deploying the VMS.

Results: This article discusses the NIH business requirements of the VP and VMS, the target KPIs of the VP and the VMS, and the NIH CC interdisciplinary approach to deploying an organizational VMS for vaccinating the NIH workforce. The use of the DCRI Spiral-Agile Software Development Life Cycle enabled the development of a system with stakeholder involvement that could quickly adapt to changing requirements meeting the defined KPIs for the program and system. The assessment of the defined KPIs through a survey and comments from the survey support that the VP and VMS were successful.

Conclusion: A comprehensive program to maintain a healthy workforce includes asymptomatic COVID testing, symptomatic COVID testing, contact tracing, vaccinations, and policy-driven education. The need to develop systems during the pandemic resulted in changes to build software quickly with the input of many more users and stakeholders then typical in a decreased amount of time.

Introduction: Universities were challenged during the COVID-19 pandemic to continue providing quality education for their students while navigating the uncertainties of the SARS-CoV-2 virus.

Objectives: The goal of this article is to describe strategies used by Colorado State University (CSU) to mitigate SARS-CoV-2 transmission among faculty, staff, and students and to describe procedures used in microbiology teaching laboratories.

Methods: Information concerning CSU's pandemic response was gathered via email communications to the CSU community, town hall meetings, and interviews with leaders, researchers, and staff who spearheaded public health initiatives.

Results: To date, there have been no known cases of transmission of SARS-CoV-2 in the classroom. Early strategies that contributed to this success included social norming of safe public health behaviors, development of low-cost, rapid screening and surveillance methods, an online COVID-19 reporting system, contact tracing and quarantine, rearranging classrooms to reduce the capacity by 50%, increasing air flow, enhanced cleaning and production of sanitizer, and flexible instructors who quickly changed their courses for remote delivery or launched extra risk management procedures for face-to-face delivery of laboratory, performance, or studio classes.

Conclusion: Intense collaboration among the CSU community, open and frequent communication, coordination of efforts, flexible instructors, and the willingness to follow safe public health behaviors allowed CSU to continue face-to-face teaching in courses that required hands-on learning or demanded in-person instruction. It is the hope of the authors that this information can provide both a historical account and useful information for others dealing with the COVID-19 pandemic.

Introduction: The ongoing COVID-19 pandemic has presented numerous challenges to education at all levels, but has been particularly challenging for professional schools and other educational sectors that require intensive hands-on training. Those institutions have had to deploy and continuously adapt new learning strategies in response to an ever-changing pandemic landscape over the past two years, while at the same time meeting the rigorous proficiency standards for their students.

Methods: This communication describes how two professional schools at Oregon State University, the College of Pharmacy and the Carlson College of Veterinary Medicine, pivoted in response to the COVID-19 pandemic to ensure continuity in student training. The adaptations included technological solutions, physical distancing, barriers, reduced group size and scheduling changes in the curriculum, and enhanced personal protective equipment.

Results: The available evidence suggest that the biosafety measures implemented to reduce the risk of COVID-19 in the hands-on educational setting appear to have been effective in preventing transmission during classroom and experiential learning activities. Professional licensing exam scores for the students of both colleges remain as high as pre-pandemic values, suggesting that the implemented changes in instruction did not have a detrimental impact on student learning. The scores will need to be monitored for several more years before firm conclusions can be drawn.

Discussion: Both colleges implemented creative solutions to the delivery of hands-on pedagogy that sought to balance risk of infection and the necessity to master critical skills that can only be acquired by active learning.

Introduction: The US regulatory environment is evolving to accommodate a boom in gene therapy research. The 2019 version of the National Institutes of Health (NIH) Guidelines on Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) lacks an appendix providing specific guidance for Institutional Biosafety Committee (IBC) review of clinical trials.

Discussion: As the field matures, the burden of Federal oversight for clinical trials of investigational products containing recombinant or synthetic nucleic acid molecules is shifting toward the Food and Drug Administration (FDA). This report summarizes recent FDA guidance documents on shedding and considerations for environmental impact assessments highlighting key points pertinent to IBC review.

Conclusion: This report helps biosafety professionals understand the evolving regulatory framework for gene therapy products. Knowledge of the guidance documents discussed in this report will assist biosafety professionals in addressing issues pertaining to shedding and environmental impact during IBC review of clinical trials.

Introduction: With the onset of the COVID-19 pandemic, a rapid adjustment of work tasks was necessary for many biosafety programs (and other safety programs) to address drastic shifts in workload demands amid pandemic-related shutdowns and subsequent needs for supporting COVID-19-related safe work protocols, diagnostic testing, research, vaccine development, and so forth. From a program management standpoint, evaluating and understanding these tasks were critically important to ensure that appropriate support and resources were in place, especially during such unprecedented times of rapid change and significant impact to normal life and routine.

Methods: Described here are examples of how the biosafety program at The University of Texas Health Science Center at Houston (UTHealth Houston) addressed these challenges.

Results: As part of this required pivot, key services and tasks emerged into three distinct categories: (1) those that were temporarily diminished, (2) those that had to continue despite COVID-19 and the associated shutdowns for safety or compliance purposes, and (3) those that dramatically increased in volume, frequency, and novelty.

Conclusion: Although the adjustments described were made in situ as the pandemic evolved, the cataloging of these tasks throughout the experience can serve as a template for biosafety programs to plan and prepare for the next pandemic, which will inevitably occur.

Background: The Animal Biosafety Level 3 Enhanced (ABSL-3+) laboratory at St. Jude Children's Research Hospital has a long history of influenza pandemic preparedness. The emergence of SARS-CoV-2 and subsequent expansion into a pandemic has put new and unanticipated demands on laboratory operations since April 2020. Administrative changes, investigative methods requiring increased demand for inactivation and validation of sample removal, and the adoption of a new animal model into the space required all arms of our Biorisk Management System (BMS) to respond with speed and innovation.

Results: In this report, we describe the outcomes of three major operational changes that were implemented to adapt the ABSL-3+ select agent space into a multipathogen laboratory. First were administrative controls that were revised and developed with new Institutional Biosafety Committee protocols, laboratory space segregation, training of staff, and occupational health changes for potential exposure to SARS-CoV-2 inside the laboratory. Second were extensive inactivation and validation experiments performed for both highly pathogenic avian influenza and SARS-CoV-2 to meet the demands for sample removal to a lower biosafety level. Third was the establishment of a new caging system to house Syrian Golden hamsters for SARS-CoV-2 risk assessment modeling.

Summary: The demands placed on biocontainment laboratories for response to SARS-CoV-2 has highlighted the importance of a robust BMS. In a relatively short time, the ABSL-3+ was able to adapt from a single select agent space to a multipathogen laboratory and expand our pandemic response capacity.

Introduction: The National Biodefense Analysis and Countermeasures Center (NBACC) is a national resource established to understand the scientific basis of the risk posed by biological threats, and to analyze evidentiary material from bioterror or biocrime events. Like many other U.S. research institutions, the emergence of the SARS-CoV-2 virus, and rapid development of the COVID-19 pandemic allowed only a few short weeks of preparations before infectious disease controls could be implemented. Due to the nature of its mission, the NBACC must be available on a 24/7 readiness posture to support bioforensic casework from the Federal Bureau of Investigation (FBI). It also serves to provide the Department of Homeland Security (DHS) with key scientific data to assess the hazard from biological agents, especially in this instance to inform the national response to COVID-19. These factors caused the operational tempo to significantly increase.

Methods: To accomplish our mission during a national emergency, laboratory staffing levels needed to be maintained at prepandemic levels. As a result, the Battelle National Biodefense Institute (BNBI) leadership took significant actions to prevent COVID-19 exposure and transmission within the workforce. These multiple actions included engineering changes to the facility, stockpiling of personal protective equipment and consumable products, educating the staff on the signs and symptoms of COVID-19, reducing the population of the nonlaboratory staff, and the completion of a comprehensive risk assessment to quantify the risk of COVID-19 infection for all NBACC staff.

Conclusion: These early actions, used in tandem, were successful in maintaining a healthy and stable workforce so that BNBI's research objectives could be met.