Viral-mediated gene therapy and genetically modified therapeutics: A primer on biosafety handling for the health-system pharmacist

Blind, Jill E; McLeod, Eileen; Campbell, Katie

doi:10.1093/ajhp/zxz056

Cited by 17 publications

(58 citation statements)

References 11 publications

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“…Most of the Investigator Brochures and also the product insert of ZOLGENSMA recommend 30-day universal or standard precautions. 126,128 In general, most health care facilities recommend universal/standard precautions with patient material between 14 and 30 days after administration for both health care staff and direct family members, dependent on viral shedding analysis. 128 Additionally, instructions are provided to family members and caregivers to practice good hand hygiene for a minimum of 2 weeks after the injection.…”

Section: Herpesviral Vectorsmentioning

confidence: 99%

“…126,128 In general, most health care facilities recommend universal/standard precautions with patient material between 14 and 30 days after administration for both health care staff and direct family members, dependent on viral shedding analysis. 128 Additionally, instructions are provided to family members and caregivers to practice good hand hygiene for a minimum of 2 weeks after the injection. 128 This requires washing hands with soap regularly and using appropriate protective gloves if coming into direct contact with patients' bodily fluids and waste.…”

Section: Herpesviral Vectorsmentioning

confidence: 99%

“…128 Additionally, instructions are provided to family members and caregivers to practice good hand hygiene for a minimum of 2 weeks after the injection. 128 This requires washing hands with soap regularly and using appropriate protective gloves if coming into direct contact with patients' bodily fluids and waste. 128 This provides an insight into the occurrence of shedding of vectors in clinical practice and can offer support for environmental risk assessment in future clinical gene therapy applications using different viral vector systems so that a consensus criteria can be developed.…”

Section: Herpesviral Vectorsmentioning

confidence: 99%

“…128 This requires washing hands with soap regularly and using appropriate protective gloves if coming into direct contact with patients' bodily fluids and waste. 128 This provides an insight into the occurrence of shedding of vectors in clinical practice and can offer support for environmental risk assessment in future clinical gene therapy applications using different viral vector systems so that a consensus criteria can be developed. Some recommendations for the Risk Assessment process for IBCs for gene therapy research using Viral Vector Systems is summarized in Figure 1.…”

Section: Herpesviral Vectorsmentioning

confidence: 99%

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Viral Vector Systems for Gene Therapy: A Comprehensive Literature Review of Progress and Biosafety Challenges

Ghosh

Brown

Jenkins³

et al. 2020

Applied Biosafety

123

113

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Introduction: National Institutes of Health (NIH) defines gene therapy as an experimental technique that uses genes to treat or prevent disease. Although gene therapy is a promising treatment option for a number of diseases (including inherited disorders, some types of cancer, and certain viral infections), the technique remains risky and is still under study to make sure that it will be effective and safe. Methods: Applications of viral vectors and nonviral gene delivery systems have found an encouraging new beginning in gene therapy in recent years. Although several viral vectors and nonviral gene delivery systems have been developed in the past 3 decades, no one delivery system can be applied in gene therapy to all cell types in vitro and in vivo. Furthermore, the use of viral vector systems (both in vitro and in vivo) present unique occupational health and safety challenges. In this review article, we discuss the biosafety challenges and the current framework of risk assessment for working with the viral vector systems. Discussion: The recent advances in the field of gene therapy is exciting, but it is important for scientists, institutional biosafety committees, and biosafety officers to safeguard public trust in the use of this technology in clinical trials and make conscious efforts to engage the public through ongoing forums and discussions.

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Section: Herpesviral Vectorsmentioning

confidence: 99%

Section: Herpesviral Vectorsmentioning

confidence: 99%

Section: Herpesviral Vectorsmentioning

confidence: 99%

Section: Herpesviral Vectorsmentioning

confidence: 99%

See 2 more Smart Citations

Viral Vector Systems for Gene Therapy: A Comprehensive Literature Review of Progress and Biosafety Challenges

Ghosh

Brown

Jenkins³

et al. 2020

Applied Biosafety

123

113

View full text Add to dashboard Cite

show abstract

“…Although the risk of seroconversion from contact with patients dosed with any gene therapy product is not available, caregivers and health care professionals are informed about how theoretically, seroconversion may limit the efficacy of future gene therapy treatment. 25 Recommendations are provided to families through the informed consent process to consider sequestering patient siblings from the treated patient to reduce the potential for exposure resulting in immunity to the viral vector. 25 In research laboratories, there is always an effort to minimize the use of sharps, and safer alternatives are used whenever possible.…”

Section: Work Environmentmentioning

confidence: 99%

Safeguards for Using Viral Vector Systems in Human Gene Therapy: A Resource for Biosafety Professionals Mitigating Risks in Health Care Settings

et al. 2020

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Introduction: Health care workers who work daily with human body fluids and hazardous drugs are among those at the highest risk of occupational exposure to these agents. The Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030) prescribes safeguards to protect workers against health hazards related to bloodborne pathogens. Similarly, the United States Pharmacopeia General Chapter 800 (USP <800>), a standard first published in February 2016 and implementation required by December 2019, addresses the occupational exposure risks of health care workers at organizations working with hazardous drugs. With emerging technologies in the field of gene therapy, these occupational exposure risks to health care workers now extend beyond those associated with bloodborne pathogens and hazardous drugs and now include recombinant DNA. The fifth edition of the Biosafety in Microbiological and Biomedical Laboratories ( BMBL) and the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) mostly govern work with biohazardous agents and recombinant DNA in a laboratory research setting. When gene therapy products are utilized in a hospital environment, health care workers have very few resources to identify and reduce the risks associated with product use during and after the administration of treatments. Methods: At the Abigail Wexner Research Institute at Nationwide Children’s Hospital, a comprehensive gap analysis was executed between the research and health care environment to develop a program for risk mitigation. The BMBL, NIH Guidelines, World Health Organization Biosafety Manual, OSHA Bloodborne Pathogens Standard, and USP <800> were used to develop a framework for the gap analysis process. Results: The standards and guidelines for working with viral vector systems in a research laboratory environment were adapted to develop a program that will mitigate the risks to health care workers involved in the preparation, transportation, and administration of gene therapies as well as subsequent patient care activities. The gap analysis identified significant differences in technical language used in daily operations, work environment, training and education, disinfection practices, and policy development between research and health care settings. These differences informed decisions and helped the organization develop a collaborative framework for risk mitigation when a gene therapy product enters the health care setting. Discussion: With continuing advances in the field of gene therapy, the oversight structure needs to evolve for the health care setting. To deliver the best outcomes to the patients of these therapies, researchers, Institutional Biosafety Committees, and health care workers need to collaborate on training programs to safeguard the public trust in the use of this technology both in clinical trials and as FDA-approved therapeutics.

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A comprehensive literature scoping review of infection prevention and control methods for viral-mediated gene therapies

Blind,

Ghosh,

Niese

et al. 2024

ASHE

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Objective: This comprehensive literature scoping review outlines available infection prevention and control (IPC) methods for viral-mediated gene therapies and provides one IPC strategy for the healthcare setting based on a single-center recommendation. Methods: A team of experts in pharmacy, healthcare epidemiology, and biosafety with experience in viral-mediated gene therapy was assembled within a pediatric hospital to conduct a comprehensive literature scoping review. The comprehensive review included abstracts and full-text articles published since 2009 and utilized prespecified search terms of the five viral vectors of interest: adenovirus (AV), retrovirus (RV), adeno-associated virus (AAV), lentivirus (LV), and herpes simplex virus (HSV). Case reports, randomized controlled trials, and bench research studies were all included, while systematic reviews were excluded. Results: A total of 4473 case reports, randomized control trials, and benchtop research studies were identified using the defined search criteria. Chlorine compounds were found to inactivate AAV and AV, while alcohol-based disinfectants were ineffective. There was a relative paucity of studies investigating surface-based disinfection for HSV, however, alcohol-based disinfectants were effective in one study. Ultraviolent irradiation was also found to inactivate HSV in numerous studies. No studies investigated disinfection for LV and RV vectors. Conclusions: The need to define IPC methods is high due to the rapid emergence of viral-mediated gene therapies to treat rare diseases, but published clinical guidance remains scarce. In the absence of these data, our center recommends a 1:10 sodium hypochlorite solution in clinical and academic environments to ensure complete germicidal activity of viral-mediated gene therapies.

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Viral-mediated gene therapy and genetically modified therapeutics: A primer on biosafety handling for the health-system pharmacist

Cited by 17 publications

References 11 publications

Viral Vector Systems for Gene Therapy: A Comprehensive Literature Review of Progress and Biosafety Challenges

Viral Vector Systems for Gene Therapy: A Comprehensive Literature Review of Progress and Biosafety Challenges

Safeguards for Using Viral Vector Systems in Human Gene Therapy: A Resource for Biosafety Professionals Mitigating Risks in Health Care Settings

A comprehensive literature scoping review of infection prevention and control methods for viral-mediated gene therapies

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