Applied Biosafety最新文献

Introduction: Positive pressure breathing-air-fed protective suits are used in biosafety level 4 (BSL-4) containment laboratories as personal protective equipment to protect workers from high-consequence pathogens. However, even with the use of primary containment devices, the exterior surfaces of these suits could potentially become contaminated with those pathogens and result in their inadvertent removal from containment. To address the risk of such pathogens escaping from containment via contaminated protective suits, these suits are decontaminated in a disinfectant chemical shower situated in an anteroom prior to exiting the BSL-4 laboratory. Properly diluted chemical disinfectants such as Micro-Chem Plus™ (MCP) or peracetic acid are used for this purpose. However, whether these suits are properly decontaminated during the chemical shower process needs to be validated.

Methods: The purpose of this study was to develop a suit decontamination validation method for the BSL-4 chemical showers using a risk group 2 (RG2) surrogate virus for the high consequence pathogens that are handled in the BSL-4 laboratories. Here, we evaluated the efficacy of a 5% MCP shower using coupons made from different parts of protective suits (suit fabric, visor, boot, vinyl tape) laden with a dried-on mixture of vesicular stomatitis virus in tripartite organic soil load.

Discussion: This validation study demonstrated that a chemical deluge shower procedure using 5% MCP for 2 min followed by a 3-min water rinse was successful in decontaminating the positive pressure suits that were experimentally contaminated with the live RG2 virus. This offers valuable insights into the rigor of the decontamination process being undertaken in the BSL-4 laboratory chemical showers.

Introduction: Artificial intelligence (AI) tools continue to be developed and used within the life sciences. The impact of these tools on the biosecurity landscape surrounding mail-order DNA synthesis and how to address the impacts have not been critically examined in the literature.

Methods: The impacts of AI-driven chatbots and biological design tools on the biosecurity landscape surrounding mail-order DNA synthesis were analyzed and described. The findings are informed by the authors' experience in the field.

Results: Generally, chatbots lower barriers to access of information that could be misused while biological design tools may provide new abilities to users with the intent of misuse. Six recommendations to the United States Government that attempt to maximize the benefits of these new technologies while mitigating risks are provided.

Conclusion: Mandating mail-order DNA synthesis providers to screen DNA synthesis orders is a critical safeguarding step that should be taken as soon as possible. Over time, biological design tools will reduce the effectiveness of such a regulation and actions should be taken now to limit the negative impacts in the future.

Introduction: A safety data sheet (SDS) is an established hazard communication tool for chemicals, for which no comparable document exists in the biotherapeutics industry. As the cell and gene therapy (CGT) field expands, industry leaders have identified a growing need to address this gap in communication of the unique occupational health and safety risks posed by CGT materials and products.

Methods: Following the sections of a traditional chemical SDS, information was modified by industry subject matter experts, relevant to CGT biological materials. This guide was developed based on assumptions of a maximum biosafety level 2, and any chemical components present in the material were excluded from the hazard classification.

Results: The guide contains necessary information to conduct a workplace risk assessment and communicate the unique workplace hazards posed by potential exposures to the material. The target audience is intended to be entities handling and producing these materials, plus collaborators, contractors, or operations sites receiving and handling the CGT material. An example of a CGT SDS is provided in Table 1.

Discussion: The CGT SDS provides industry with a best practice to address an existing gap in hazard communication for CGT. We expect that, as the field evolves, so may the contents. The CGT SDS can be used as a reference for other biological modalities in the field.

Conclusions: This initial CGT SDS communicates workplace hazards and assesses the unique risks posed by these biological materials and can assist in creating exposure control plans specific to the workplace hazards.

Introduction: The virus formerly known as monkeypox virus, now called mpoxv, belongs to the Orthopoxvirus genus and can cause mpox disease through both animal-to-human and human-to-human transmission. The unexpected spread of mpoxv among humans has prompted the World Health Organization (WHO) to declare a Public Health Emergency of International Concern (PHEIC).

Methods: We conducted a literature search to identify the gaps in biosafety, focusing on five main areas: how the infection enters the body and spreads, how much of the virus is needed to cause infection, infections acquired in the lab, accidental release of the virus, and strategies for disinfecting and decontaminating the area.

Discussion: The recent PHEIC has shown that there are gaps in our knowledge of biosafety when it comes to mpoxv. We need to better understand where this virus might be found, how much of it can spread from person-to-person, what are the effective control measures, and how to safely clean up contaminated areas. By gathering more biosafety evidence, we can make better decisions to protect people from this zoonotic agent, which has recently become more common in the human population.