Introduction

We are pleased to introduce this themed section of Applied Biosafety that specifically focuses on biosafety innovations. The innovations described in these articles provide a model to address safe work practices and exposure prevention involving cell and gene therapy (CGT) as well as a new tool for the inactivation of zoonotic pathogens in an agricultural setting. They transform how conventional and unique situations are addressed, providing much needed and achievable solutions. The original research showcased in these articles has generated information, and tools that can be applied and adapted to solve problems in a variety of settings including but not limited to academic, research and development (R&D), biopharmaceutical, biotechnology, and agricultural.

CGT is currently growing exponentially, and rapidly emerging technologies result in synthesis and handling nontraditional, novel, or proprietary substances for which biosafety standards have not yet been firmly or universally established. Hodges et al. recognized that an analogue to the gold-standard technical document for communicating chemical risks, the Safety Data Sheet (SDS), does not currently exist for biological risks associated with biopharmaceutical to guide CGT practitioners.

The BioPhorum EHS and Biosafety working group developed an SDS template specifically for CGT materials that mirrors the global harmonized standard format of a chemical SDS, and they provide guidance for how to use the CGT SDS template. The CGT SDS is a helpful tool in conducting a workplace risk assessment and communicating workplace hazards posed by potential exposures. This template and guidance could potentially be used in defining, communicating, and mitigating risk with other evolving and novel biotherapeutic modalities that currently lack descriptive safety information that can be easily understood and interpreted.

In “EHS Biosafety Risk Assessment for a Theoretical Model of a Gene Therapy Process Transfer from R&D to Large-Scale Manufacturing,” Balbo et al. have developed a comprehensive risk assessment guide and table that can be used to identify risks and reduction strategies in clinical/commercial manufacturing settings using current good manufacturing practice (cGMP) during the production of human CGT products involving human cell lines. A global consortium of environmental health and safety and biosafety experts developed the guide to define biosafety controls and illustrated its application for a theoretical process involving transfer and scale up of a human cell bank from an R&D environment to a GMP manufacturing setting.

Certain specific elements of biosafety level 2 controls were identified that could safely be reduced to biosafety level 1 in production settings when implementing cGMP practices for well-characterized cell lines that are tested for adventitious pathogens. This approach could allow for retrofitting existing facilities to facilitate more rapid manufacturing timelines in the production of CGT products for patient use without compromising workplace biosafety.

Outbreaks of Mycobacterium bovis in cattle occur even in countries with control programs, since it can be transmitted by persistently infected wild animals. Guan, Chan, and Rohonczy evaluated the use of pressurized steam under freezing conditions in the presence of organic load to decontaminate disks (steel, rubber, and wood) inoculated with 10⁶ CFU of Mycobacterium terrae. M. terrae served as a surrogate for M. bovis, which is a zoonotic agent with a low infectious dose that threatens both animals and humans and causes disease that can lead to significant economic damage.

Challenges to the use of chemical decontaminants include toxicity to animals, damage to equipment, and lack of efficacy in freezing temperature or organic load, hence the innovative idea to use pressurized steam. The results demonstrated that short-term exposure to pressurized steam reduced viability of M. terrae by 6 logs. This technology could be important in decontamination of farms and equipment in countries that experience freezing weather.

The innovative articles in this issue of Applied Biosafety provide essential biosafety information for risk assessment in the biopharmaceutical industry and pathogen inactivation in harsh real-world environments. These articles are available online by our publisher Mary Ann Liebert, Inc., publishers at (https://home.liebertpub.com/publications/applied-biosafety/661/overview).