Bio-containment has potent compounds, focused primarily on chemically derived drug substances and drug components, while analogous to chemical potent compounds. Biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring life forms and their by-product write Herman F. Bozenhardt and Erich H. Bozenhardt in pharmaceuticalonline.com.
Difference between Chemical Reactor and Bioreactor
The main difference between the chemical reactor and the bio-reactor is that the chemical reactor has a finite life in the vessel, while the biological agent is adaptive to our planet and humanity notes the report.
The diversity and complexity of pharmaceutical products developed over the years have pushed the research to explore the humongous types of bacteria, fungi, viruses, and animal forms (including the exotic) on the earth. “We utilize cell cultures from humans, insects, plants, and animals and with impunity genetically engineer them for our therapies. We must, therefore, practice a very careful assessment of our biological processes and develop robust containment strategies and designs for the safety of our environment and personnel”, says the report.
Stating that the bio-containment might seem like a relatively new topic for the industry, the report goes on to add that the practice of bio-containment actually dates back to the days of development of the smallpox vaccine (1796), research by Louis Pasteur (mid-1800s), and the development of the Salk vaccine (1955).
What is more, it is also pertinent to recall that, way back in 1955, the pharmaceutical industry was shocked by the “Cutter Incident,” in which a breach of containment caused thousands of children to be exposed to the live polio virus, resulting in paralysis and death for some of them the report pointed out.
The Cold War drove countries to develop laboratories and facilities (e.g., Fort Detrick, Pine Bluff, Porton Down, Zagorsk, Sverdlovsk, etc.) that practiced bio-containment. These facilities and their methods provided the early guidelines for the U.S.-based National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), which continues to provide our primary guidance today. The CDC and its analogous organizations around the world have harmonized on bio-containment and have developed the concept of bio-safety levels, or BSL, to categorize the risks and threats of biological agents and methods to contain them, the report said.
The handling of any biological agent requires an understanding of the agent and the risk of exposure to personnel, the facility, and the environment. The CDC and the NIH have used risk assessment to develop four ascending bio-safety levels of containment required for use with biological agents, as follows:
BSL 1 – work or processing involving well-characterized agents not known to cause disease in healthy adult humans, and of minimal potential hazard to personnel and the environment
BSL 2 – working with or processing agents of moderate potential hazard to personnel and the environment
BSL 3 -- processing or handling of indigenous or exotic agents that may cause serious or potentially lethal disease as a result of exposure by the inhalation route
BSL 4 –working with or processing a dangerous and exotic agent that poses a high individual risk of aerosol-transmitted laboratory infection and life-threatening disease.
In April 2002, the NIH published guidelines specifically directed at the industry that took a similar approach, but with more detail, called NIH Guidelines on Recombinant DNA:
Risk Group 1 (RG1) – the agents used are not associated with disease in healthy adult humans
Risk Group 2 (RG2) – the agents are associated with human disease that is rarely serious and for which preventive or therapeutic interventions are often available
Risk Group 3 (RG3) – the agents are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available
Risk Group 4 (RG4) – the agents are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available
If you are designing or building facilities around the world, most countries have their own equivalent regulations, and you are required to adopt their terminology.
European Economic Community (Directive 93/88/EEC) is very similar to the NIH guidelines but adds the concept of hazards spreading to the community as part of the risk criteria. Furthermore, the Canadian Laboratory Bio-Safety Guidelines use the same terminology as the U.S. NIH; however, they take a matrix approach, looking at both individual risk and community risk as equal factors, added the report.