Share thisBiocontainment is a unique area of operations for Contract Research Organizations.
In this, our latest in a series of articles focusing on contract research organization, we chose to obtain insight on a more unique area of CRO operations – biocontainment and animal biosafety. The biocontainment concepts discussed by the authors below focus on the need to contain infectious agents during work with them in animals. These concepts, combined with the procedures involved in the defined animal biosafety levels, allow for safe research on organisms that could otherwise cause harm to people working in the laboratories, other animals in the facilities, or the environment. Increasingly, many organizations are seeing the need to outsource studies involving infectious agents to CROs who specialize in such work. These studies support antimicrobial, bioweapon detection, and human and animal health vaccine development.
The Uniqueness of a Biocontainment CRO
Gloria Sivko, DVM, Ph.D.
Work performed at a biocontainment CRO is similar to other CROs across the nation – sponsors come looking for a facility to test their products under Good Laboratory Practice (GLP) guidelines. What ‘ups the ante,’ so to speak, is that these sponsors want their products tested against pathogens that you wouldn’t want to meet on the street; i.e. those categorized as select agents or toxins by the United States Department of Health and Human Services (DHHS) [Center for Disease Control and Prevention (CDC)] and/or United States Department of Agriculture (USDA). Most of this work must be performed in a Biosafety Level 3 (BSL-3)/Animal BSL-3 facility according to the guidelines presented by DHHS in the Biosafety in Microbiological and Biomedical Laboratories publication (2007). These guidelines are in addition to the required accreditations, policies, and procedures discussed in the previous articles for CROs performing animal studies in general.
What does this all mean for the animal technician, microbiology technician, study director, or quality assurance auditor who chooses to work for a biocontainment CRO? In two words – more showers! Seriously, up front, it means security paperwork, vaccinations, medical monitoring; and training, training, and more training. An awareness of the hazards of what one is working with, the engineering controls in place within the facility, and the appropriate personal protective equipment (PPE) required to conduct work safely are essential. Powered Air Purifying Respirators, the funny-looking hoods you’ve seen in movies, are an essential part of daily life. Learning to live with the constant whirring, flow of air over your face, heavy battery pack around your waist, and the feeling that you’re in your own little world takes some getting used to; not to mention makes scratching that random itch on your nose or pushing up your glasses rather difficult. And don’t even think about sneezing!
Those who work in the BSL-3 on a daily basis find themselves having to be more proactive, prepared, organized, and detail-oriented. Once you’re in the lab, you’re there – to come out because you forgot something means another shower and more time wasted. There is no such thing as a five minute snack break. In a BSL-3 lab, everything has an added layer of complexity. Animal technicians must effectively and safely handle infected animals while avoiding teeth and claws, all the while working under the weight of additional layers of PPE and/or the nuances of containment caging. Microbiology technicians working with infected samples or agents in biosafety cabinets are required to wear aprons, sleeves, and double gloves. Anything removed from the cabinet (including hands and arms) must be decontaminated prior to removal. Just reaching out to grab a forgotten item isn’t an easy task.