Lec 6

Biosafety and Biosecurity College of Pharmacy / 2022-2023
Pathogen Hazards
The principal hazardous characteristics of an agent are: its capability to infect
and cause disease in a susceptible human or animal host, its virulence as
measured by: the severity of disease, and the availability of preventive measures and
effective treatments for the disease.
Biological agents include:
1. All microorganisms and their toxins

2. Viruses and sub-viral particles (including prions)
3. Recombinant products (plant, animal, microbial)
4. Parasites (microscopic, as well as macroscopic)
5. Cultured human and animal cells and the potentially infectious agents that
these cells may contain
6. Clinical specimens (human or animal blood, body fluids, cells, tissues, bone)
7. Whole animals and tissues from experimentally infected animals
8. Allergens (such as molds, microbial spores, and animal allergens)
Risk Groups
Classification of organisms according to risk group has traditionally been used
to categorize the relative hazards of infective organisms. The factors used to
determine which risk group an organism falls into is based upon the characteristics
of the organism, such as
1. Pathogenicity
2. Infectious dose
3. Mode of transmission
4. Host range
5. Availability of effective preventive measures
6. Availability of effective treatment.
1
The World Health Organization (WHO) has recommended an agent risk group
classification for laboratory use that describes four general risk groups based on
these principal characteristics and the route of transmission of the natural disease.
Human blood, blood products, body fluids, tissues, and cells
Infection is the factor that has been seriously concerned when handling blood and
products of human origin as HIV, Hepatitis B and Hepatitis C are examples of the
infectious materials from such samples. Other agents such as fungi, bacteria, or viral
agents may also present causing infections. Representative infections include
tuberculosis and brucellosis.
2
Recombinant DNA
Genetic material, either natural or synthetic, can be combined to construct novel
rDNA. rDNA technologies, are widely used in modern-day research and industry
and have many applications, including the production of transgenic animals, the
cloning of microbial toxin genes, drug resistance genes, or other genes in
expression vectors, as well as the production of full-length infectious viral clones.
While there are numerous beneficial uses for rDNA technology, there is also the risk
that this technology can be used to create new pathogenic organisms or to increase
the pathogenicity of existing organisms, whether intentionally or not.
Genetically Modified Organisms (GMOs)
GMOs are organisms (i.e., plants, animals, or microorganisms) that are created
through the alteration of genetic materials in a way that does not occur naturally
through mating or natural recombination. The best-known method for creating
GMOs is through the application of rDNA technologies. A GMO can be as simple
as a point-mutated bacteria strain (e.g., E. coli DH5-Alpha) or rDNA cloned into a
viral host (e.g., vaccinia virus vaccines) to overexpress a specific gene for further
study. More complex GMOs include transgenic and knock-out animals (e.g., severe
combined immunodeficiency mice) whose genome has been altered by the insertion,
deletion, or alteration of DNA segments.
Experiments involving the construction or use of GMOs should be conducted
after performing a biosafety risk assessment. The pathogenic properties and any
potential hazards associated with such organisms may be novel and not well-
characterized. The properties of the donor organism, the nature of the DNA
sequences that will be transferred, the properties of the recipient organism, and the
properties of the environment should be evaluated. These factors should help
determine the biosafety level that is required for the safe handling of the resulting
GMO and identify the biological and physical containment systems that should be
used.
Lec. Dr. Ali S. Jabbar

BSc, MSc, Ph D

Lec 6

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Biosafety and Biosecurity College of Pharmacy / 2022-2023

Biological agents include:

1. All microorganisms and their toxins

Human blood, blood products, body fluids, tissues, and cells

Lec. Dr. Ali S. Jabbar

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