1. Biosafety and Bioethics of Biotechnology ABS-832
Dr Attya Bhatti
Assistant Professor
Head of Department
ASAB-NUST

2. Course Contents Principles of Biosafety
Biotechnology: benefits and concerns/risks
Procedures and good laboratory practices (GLPs)
Bioethics and social issues: Theories of bioethics
challenges facing modern biotechnology research and application
Standard operating procedures for research involving microbes and recombinant DNA
Management of intellectual property: patenting copyrights and trademarks
Designing of containment facilities: laboratories
Biosafety cabinets
intellectual property rights as applied to biotechnology
Greenhouses
Ethical theories
intellectual Property key policy issues in the research setting
Ethical principles
Protection of traditional knowledge for biotechnology innovation
Ethical issues surrounding GMOs and recombinant DNA research
national and international and legal and regulatory framework for Intellectual property and relevance to biotechnology
National policies for biotechnology products and research
Principles of Risk assessment and management
Challenges of Biotechnology policy development and implementation
Biosafety procedures: Assigning of Biosafety levels
Features of the Uganda biotechnology and Biosafety policy and its linkage to other national and global policies
The concept of Biosecurity
National guidelines for research with GMOs and microbes

3. Recommended Books Bioethics and Biosafety by M. K. Sateesh
Bioethics and Biosafety in Biotechnology by V. Sree Krishna
(Online available)
Toward a More Natural Science: Biology and Human Affairs by Kass, Leon
Cutting-Edge Bioethics by Kilner, John. Eerdmans
Biological Safety: Principles And Practices (Biological Safety: Principles & Practices) by Diane O., Diane O., Ph.D. Fleming and Ph.D. Fleming
Biotechnology, Biosafety, and Biodiversity: Scientific and Ethical Issues for Sustainable Development by Sivramiah Shantharam, Jane F. Montgomery and Satellite Symposium on Biotechnology and Biodiversity

4. Assignments: Every Student will present Assignment/seminar
Quiz: Class Quizzes will held after 2-3 lectures
Total Credits: 3(3-0)
Class Timing: (11 30 hrs – 1300hrs)
Tuesday
Thursday

5. Marks Distribution
Ist sessional Exam = 15%
2nd sessional Exam = 15%
Assignments= %
Quiz= %
Class attendance= 1%
Final Exam= %

6. Biosafety
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health.
The maintenance of safe conditions in biological research to prevent harm to workers, non-laboratory organisms, or the environment.
A fundamental objective of any biosafety program is the containment of potentially harmful biological agents.
The term “containment” is used in describing safe methods, facilities and equipment for managing infectious materials in the laboratory environment where they are being handled or maintained.

7. Technical Definitions
Biohazard: An agent of biological origin that has the capacity to produce deleterious effects on humans, i.e. microorganisms, toxins and allergens derived from those organisms; and allergens and toxins derived from higher plants and animals.
Biosafety: The containment principles, technologies and practices that are implemented to prevent the unintentional exposure to pathogens and toxins, or their accidental release.
Biosecurity: Control of accidental and deliberate release of biohazardous material

8. Why we need Biosafety

9. Some unfortunate examples of disease outbreaks in research labs:
1950‐1976:
•A survey of 5000 labs showed 3921 cases of disease outbreaks
•Most commonly reported were: Hepatitis, tuberculosis, typhoid, brucellosis, rabbit fever :
•SARS infects researchers in a lab in Singapore
•A US and a russian scientist are infected by Ebola. One survives, one dies.
•Polio virus escapes from two idian labs
•Scientists from Boston University contract rabbit fever (a serious bacterial disease)
•Anthrax exposure in a Huston lab due to aerosols leaked inside an unshielded
Centrifuge
Dengue
Ebola

10. Support medical and scientific research on microbes and the human immune response to them.
Apply such research to the discovery and development of vaccines, drugs, and diagnostic tests designed to protect the general population
Ensure that the every has sufficient research facilities to carry out these activities.

11. Biosafety in Various Disciplines
Biosafety is related to several fields
ECOLOGY
AGRICULTURE
MEDICINE
CHEMISTRY
EXOBIOLOGY

12. Biosafety in Academic Research
Research Universities:
Promoting safe laboratory practices,
Procedures; proper use of containment equipment and facilities;
Provides advice on laboratory design and risk assesment of experiments involving infectious agents, rDNA in-vitro and in-vivo.
Bottom Line: Risk & Containment

13. Biohazard Symbol
In 1966, Charles Baldwin at National Cancer Institute at NIH.
Symbol to be memorable but meaningless” so it could be learned.
Blaze orange – most visible under harsh conditions

14. Biosafety Issues Laboratory Safety Bloodborne pathogens (BBP)
Recombinant DNA (rDNA)
Biological waste disposal
Infectious substance and
diagnostic specimen shipping

15. Biosafety Issues Respiratory Protection Bioterrorism and Select agents
outdoor and indoor air quality
Occupational safety and health in the use of research animals
Biohazards used in animal models

17. Biohazardous Materials
Viruses
Bacteria
Fungi
Chlamydiae/Rickettsiae
Prions
Recombinant DNA

18. Types of pathogens Bacteria – Size: 0.3 to 2 μm
– Single‐celled organisms
– Various morphologies
– Examples: Salmonella spp., E. coli, Vibrio spp. (Cholera),
Mycobacterium (Tuberculosis)

19. Virus
– Size: 18‐200 nm
– Basic structure: capsid (protein) + nucleic acid
– Obligate parasites
– Enveloped vs. non‐enveloped
– Examples: Hepatitis, polio, HIV

20. Protozoa – Size: 5‐10 μm – Single‐celled eukaryotes
– Numerous morphologies
– Examples: Cryptosporidium spp., Plasmodium spp. (Malaria), Giardia spp.

21. Helminths – Size: 20‐100 μm – Multi‐cellular eukaryotes
– For transmission mainly concerned with eggs

23. Biohazardous Materials
Transgenic Plants, Animals and Insects
     
   

24. Biohazardous Materials
Human and Primate Cells, Tissues, and Body Fluids
Brain Tissue from Demented Patients
Viral Vectors
Replication deficient viruses

25. Biosafety Concepts Biosafety In Microbiological
and Biomedical Laboratories
“BMBL” (acronym)
CDC/NIH Publication
Safety “Guidelines”
Regulations of Institution receives
NIH funding
Code of Practice and “Gold” Standard in Industry
Gold Standard
HHS Publication No. (CDC)