prof dr badr elsabah biosafety in biotech

Safety Aspects in Biotechnology:

Classifications, Safety Measurements

and Precautions for Biological Workers

Badr El-Sabah A. Fetoh

About Speaker:Professor and Head Research in Plant

Protection Research Institute, ARC, Egypt

Editor in Chief in Biochemistry and

Biotechnology Research Journal, UK.

Email: drabadrelsabah@hotmail.com

Prof. Badr El-Sabah A. Fetoh

When Biotechnology

begin?

What is Biotechnology?Processing of substances by biological agents to

produce goods and services.

Biological agents: mainly microbes, animal and

plant cells and enzymes.

Substances: renewable materials as well as those

produced by microbes.

Goods and services: food,, pharmaceuticals, etc.

Biotechnology• Biotechnology helps to meet

our basic needs.

• Food, clothing, shelter, health

and safety

Plants and animals are used in manufacturing food, clothing and materials for shelter

Biotechnology

Used to make products

more useful or desirable

Ex: conversion of milk into

cheese or yogurt

Biotechnology

• Improvements by using

science

• Science helps in production

plants, animals and other

organisms

Biotechnology

• Also used in maintaining a good environment that promotes our well being

Biotechnology

• Using scientific processes to

get new organisms or new

products from organisms.

Biotechnology

• Large area

• Includes many approaches

and methods in science and

technology

Application of Biotechnology :

No matter your research, likely to

encounter biotechnology……….

Green Agriculture/Envirnoment

Red Medical

Yellow Food Biotechnology

Blue Aquatic

White Gene-Based Industry

Grey Fermentation

Brown Arid

Gold Nanotechnology/Bioinformatics

Purple Intellectual

Dark Warfare/Bioterrorism/

Sunday, Sep. 20, 2009

Did the Plague Kill Illinois Scientist?

(AP / CHICAGO) — The University of Chicago Medical Center says the

infection that killed a scientist may be connected to bacteria he

researched that causes the plague.

The university said Saturday that its researcher studied the genetics of

harmful bacteria including Yersinia pestis, which causes the illness.

He died Sept. 13. His name and age haven't been released

The medical center says the bacteria he worked with was a weakened

strain that isn't known to cause illness in healthy adults. The strain

was approved by the Centers for Disease Control and Prevention for

laboratory studies.

An autopsy found no obvious cause of death but did find the presence

of the bacteria. More tests are planned. No other illnesses have

been reported.

In June 2014 about 75 American researchers faced to

anthrax.

After just one month, and during the cleaning routine

laboratory at the National Institute of Health in the United

States, appeared 16 vials containing the smallpox virus,

found in misplaced storage repositories.

Fortunately, no one gets sick, but the uproar caused by

this issue prompted the Obama administration to stop

funding the controversial research, which deliberately

make diseases such as bird flu and SARS more virulent.

What is Safety?

Safety from exposure to Infectious

Agents and dangerous conditions

Biosafety in Various Disciplines

Biosafety is related to severalfields……..

•ECOLOGY: referring to importedlife forms not indigenous to theregion (Reggie the alligator).

•AGRICULTURE: reducing therisk of alien viral or transgenicgenes, or prions such asBSE/"MadCow―; reducing the riskof food bacterial contamination.

•MEDICINE: referring to organs ortissues from biological origin, orgenetic therapy products, virus;levels of lab containment protocolsBSL-1, 2, 3, 4 in rising order ofdanger.

•CHEMISTRY: i.e., nitrates in water, PCB levels affecting fertility.

•EXOBIOLOGY: i.e., NASA's policy for containing alien microbes that may exist on space samples - sometimes called "biosafety level 5―.

Biosafety in Academic Research

Research Universities:

Promoting safe laboratorypractices, and procedures;proper use of containmentequipment and facilities;provides advice onlaboratory design and riskassessment of experimentsinvolving infectious agents,rDNA in-vitro and in-vivo.

Biohazard Symbol

• In 1991Charles Baldwin at National Cancer Institute at NIH, USA.

• Symbol to be ―memorable but meaningless‖ so it could be learned.

• Blaze orange – most visible under harsh conditions

Biosafety Issues

• Laboratory Safety

• Bloodborne pathogens (BBP).

• Recombinant DNA (rDNA).

• Biological waste disposal.

• Infectious substance and

diagnostic specimen shipping.

• Genetically Modified Organisms (GMO).

Biosafety Issues (con’t.)

• Respiratory Protection

• Bioterrorism and Select

agents

• Mold and indoor air quality

• Occupational safety and

health in the use of

research animals

• Biohazards used in animal

modelsProf. Badr El-Sabah A. Fetoh

Biohazardous Materials

• Viruses

• Bacteria

• Fungi

• Chlamydiae/Rickettsiae

• Prions

• Recombinant DNA

Biohazardous materials• Transgenic Plants, Animals and Insects

In 2014 Chinese team researchers announced the first birth of

monkeys genetically modified, by modifying the new Jenny called

"CRISPR / Cas9" system, and the promise of this technology with a

new generation of monkeys specially designed for research, for the

best ways to discover for the treatment of human disease.

This discovery raises many ethical questions about how we deal with

this emotional and intelligent creatures.

Biohazardous Materials

• Human and Primate Cells, Tissues, and

Body Fluids

• Brain Tissue from Demented Patients

• Viral Vectors

– Replication deficient viruses

Biosafety Concepts for Biotech.

• Practice and Procedures

– Standard Practices

– Special Practices & Considerations

• Safety Equipments

• Facility Design and Construction

• Increasing levels of protection

Principles of BiosafetyBiosafety Levels 1-4 (BSL)

• Increasing levels of employee and environmental protection

• Guidelines for working safely in research & laboratory facilities

Animal Biosafety Levels 1- 4 (ABSL)

• Laboratory animal facilities

• Animal models that support research

• Guidelines for working safely in animal research facilities

Biosafety Concepts

(1) Standard Microbiological Practices

• Most important concept / Strict adherence

• Aware of potential hazard

• Trained & proficient in techniques

• Supervisors responsible for: – Appropriate Laboratory facilities

– Personnel & Training

• Special practices & precautions– Occupational Health Programs

(2) Safety Equipments• Primary Containment Barrier

• Minimize exposure to hazard– Prevent contact / Contain aerosols

• Engineering controls/ equipment

• Personal Protective Equipment (PPE)– Gloves, gowns, Respirator, Face shield, Booties

• Biological Safety Cabinets

• Covered or ventilated animal cage systems

(3) Facility Design and Construction

• Secondary Barrier/ Engineering controls

• Contributes to worker protection

• Protects outside the laboratory

– Environment & Neighborhood

• Ex. Building & Lab design, Ventilation, Autoclaves, Cage wash facilities, etc.

Laboratory Design

Biosafety Level-1 (BSL-1)• Well characterized agents

• Agents not known to cause disease (in healthy human adults; now healthy immunocompetent adults)

• Prophylactic treatment available

• Open bench procedures

• Animals in open cage system or open environment (outdoors)

• Good laboratory practices

Risk Group 1 Agents

• E.coli K-12

• Transgenic Plants

• Plasmids

• Fungi

• Mold

• Yeast

BSL-1 Practices

• Bench-top work allowed

• Daily Decontamination

• Manual pipetting

• Required Handwashing

• Red bag waste

• Bio cabinet not required (unless

creating aerosols)

• 2˚ containmentProf. Badr El-Sabah A. Fetoh

Risk Group 2 Agents

• Human or Primate Cells

• Herpes Simplex Virus

• Replication Incompetent Attenuated Human Immunodeficiency Virus

• Patient specimens

BSL-2 Practices

Practices & Procedures• Agents associated w/ human disease

• Treatment for disease available

• Agent poses moderate hazard to

personnel and environment

• Direct contact or exposure

• Percutaneous exposure

– Scratch, Puncture, Needle stick

• Mucus membrane exposure

– Eyes, Mouth, open cut

BSL-2 Practices

• Limited access to lab when work

in progress

• Daily decontamination

• Mechanical pipetting

• Labcoat, safety glasses and

gloves required

• Red bag & sharps containers

required

BSL-2 Practices (con’t)• Biohaz. Sign posted at

entrance to lab

• Label all equipment

(incubators, freezers, etc.)

• TC room – negative air flow

• Documented training

• Baseline serology or pre-

vaccination may be

required

Risk Group 3 Agents

• Human

Immunodeficiency

• Mycobacterium

tuberculosis

• Coxiella burnetii

Biosafety Level 3Working in High

Containment

Biosafety Level-3 (BSL-3)

• Indigenous or exotic agents

• Aerosol transmission

• Serious health effects

• Treatment may or may not exist

BSL-3 Practices

• Public access NOT permitted

• Daily decontamination after spill and

upon completion of experiment

• Autoclave required and waste is

disposed at the end of day

• Required foot activated

handwashing sink and controls

• No sharps unless absolutely

necessaryProf. Badr El-Sabah A. Fetoh

BSL-3 Practices (con’t)• Aerosol minimization procedures required

• Wrap around disposable clothing is

required. Specialized equipment may be

required depending upon procedures

• Biohaz. Signs and labels posted

• Air flow from low hazard to high hazard

―Pressure Mapping‖

BSL-3 Practices (con’t)• Bench top work not permitted

• Documented training and personnel competency

certification (for BSL-3 procedures)

• Baseline serology

• Spills – report immediately and treat accordingly

• Vaccinations/post exposure protocols and

SOP’s, Biosafety Manual, Biosafety Officer

Biosafety Level-4Working in High Containment

Biosafety Level-4• Builds on BSL-3 practices

• Maximum containment facilities

• Pressurized Containment Suite– BSL-3 + Class III Biosafety Cabinet

• Chemical decontamination showers

• Liquid effluent collection / decontamination

Biosafety Level 4

• Lassa Fever Virus

• Ebola

Hemmorrhagic

Fever Virus

• Marburg Virus

• Herpes B Virus

Biosafety ConceptsWorking in High

Containment

Biosafety Level-4 (BSL-4 )

• Dangerous/exotic agents

• Life threatening disease

• Aerosol transmission

• Agents of unknown risk

of transmission or health affects

• No known treatment

Animal Biosafety Level-4Working in High Containment

General Good Lab Technique• Hygienic Practices

– No Smoking, Eating, Applying cosmetics, lip

balm, contacts

– Wash hands after procedures

– Decontaminate lab bench before and after

General Operational Practices

• Proper attire

– Minimum – lab coat, safety glasses, gloves

• Plan your work

– Know in advance what you are working

– Read available resources like:

Blue Book:

http://www.oecd.org/dataoecd/45/54/194

3773.pdf

http://www.hc-sc.gc.ca/pphb-dgspsp/msds-

ftss/index.html Prof. Badr El-Sabah A. Fetoh

Animal Containment Points

1957 2005

Risk Assessment

In-Vitro In-VivoHuman Clinical

Addressing Risk Assessments

• What is the organism?

• Is it Wild-type, attenuated, irradiated, or chemically treated? Look at kill data or kill curves.

• What is the max. concentration, volume, infectious dose?

• What is the work space like?

• Aerosolizing procedures? How do they contain their aerosols?

Risk Assessment, con’t• Are personnel trained? Do

personnel understand the organism, infectious dose and symptoms?

• What are their experimental procedures?

• Will they be transporting the material? Shipping intra, inter-state or international?

• Are they doing tissue culture?

• Do they have adequate containment equipment?

Risk Assessment, Con’t• Are they doing this

work in-vivo? Have you consulted and discussed this with the Vets and IACUC to determine special needs and housing?

• Waste issues addressed?

• Pregnancy issues with the organisms?

Risk Assessment, con’t

• Do they share their

Tissue Culture room?

• Do they have more

than 1 Biosafety

Cabinet?

• Occupational Health

informed and set up to

receive patient or offer

counseling?Prof. Badr El-Sabah A. Fetoh

Accidental Spills

Evacuate area, alert personnel and

cordon off so that aerosols may settle

Don PPE; Cover with paper towels and

apply bleach (1 part bleach : 9 parts water

Allow 15 – 20 min contact time

Wipe up working towards center

Use tongs if broken glass is involved

Is Recombinant DNA involved?

First Aid Measures

• Splash to Eye or Needlestick Injury

– Rinse thoroughly for 15 minutes at the eyewash or

What Helps?

To be safe in biotech lab you must

focus on the following items:

• Risks versus Benefits

• Hazardous Materials Used in

Biotechnology—Handling and

Disposal

• Good Manufacturing Practices

• Good Laboratory Practices

• Good Laboratory Practice Principles.

Thank you for your attention !

drabadrelsabah@hotmail.com

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