Introduction, Pharma/Biotech Industry and Products

Question 1

Major Events

6 events

Not cool

Answer 1

Polymerase Chain Reactions
Louis Pasteur Fermentation
Antibiotics discovery/production
Watson/Crick DNA structure
CRISPR
Recombinant DNA technology

Question 2

Examples of Biotech Products

10 Examples

Answer 2

Fermentation products
Proteases for detergents
Flavor
Fragances
Antibiotics
Cell Biomass
Waste Treatment
Bioconversion products
Amino Acids
Vitamins
Biosensors
Recombinant Plants
Bioremedations
Viral Vaccines
Viral Insecticides
Transgenic Animals

Question 3

Meaning of Biologics

Answer 3

Biologics are medications developed from blood, proteins, viruses, or living organisms.

Question 4

FDA approval process

Phases and Key Issues

Answer 4

Phase I: Designed to determine the metabolic and phamacological actions of drug in humans. (key issue: safety).
Phase II: Obtain more data on durg efficacy (key issue: efficacy).
Phase III: Evaluate overall benefit-risk relationship of the drug. (key issue: efficacy and safety).

Cost: 0.2~1.3 Billion USD

Question 5

CRISPR/cas 9

Answer 5

Developed to edit mammalian cell genomes
Widely used for gene editing: snips undesired DNA

Clustered Regularly Interspaced Palindromic Repeats

Question 6

CAR-T cell therapy

Chimeric Antigen Receptor

Answer 6

Form of immunotherapy that uses specially altered T cells to fight cancer
T cells are collected from blood