Biotechnology

How is biotechnology defined?

Creation of a product from natural resources and biological processes.

What is considered the earliest known form of biotechnology?

Harvesting of grapes to make wine (seen in an Egyptian hieroglyph).

What is the root cause of Type I diabetes?

Immune system destroys beta cells in the pancreas; insulin isn't released, causing blood sugar to stay dangerously high (toxic).

What is insulin's primary function and who produces it?

Signal released by beta cells when sugar (glucose) is high; tells body/fat cells to take up sugar.

What is glucagon and what does it do?

Released by alpha cells when sugar is too low; tells the liver to release glucose to restore balance.

What were the initial sources of insulin used for human treatment?

Extract from dogs to treat diabetes, later switched to pig insulin (similar to human and an agricultural product).

What is Recombinant DNA?

The process of recombining DNAs from different sources.

In cloning, what is a vector, and what serves as the molecular vector?

A transportation tool that shuttles material from place to place. The molecular vector is the plasmid.

List the key steps in creating Recombinant Human Insulin.

• Synthesize the human insulin DNA gene,

• join with plasmid DNA,

• introduce into bacteria (E. coli),

• bacteria synthesize human insulin

• insulin is purified away from bacterial protein, which results in a finished product that diabetics inject

What are the main advantages of recombinant human insulin over animal sources?

• bacterial protein is IDENTICAL to human pancreatic insulin

• avoids rejection of animal insulins by the immune system

• recombinant protein can be obtained in unlimited supply/ is very pure

• recombinant protein is more expensive

What is the function of the Ampicillin resistance gene on a plasmid?

A selection marker that ensures only bacteria that took up the plasmid (and the gene of interest) survive antibiotics.

What is a DNA "library" in molecular cloning?

A collection of plasmids where each contains a different piece of the chopped-up genome/DNA fragments.

What is the approximate cost to produce one vial of insulin today, and why is it so low?

Estimated $2 to $4 per vial today, due to old technology

Name the major factors driving the high cost of insulin.

• Limited Competition (3 main companies: Eli Lilly, Sanofi, Novo Nordisk)

• PBMs (middlemen),

• Evergreening and Patents,

• the shift to expensive analogs.

What is the role of Pharmacy Benefit Managers (PBMs)?

Middlemen who negotiate rebates with drug companies, aiming to reduce costs for insurers

What is the pharmaceutical practice known as “Evergreening”?

Extending patent protection by patenting small modifications of an existing drug, potentially indefinitely, thus delaying generic production.

Explain the B Cell Attack concept (Concept 2 for vaccines).

B cell finds the antigen (target), creates a clonal army, which becomes plasma cells that fire out antibodies to neutralize the target

What is the purpose of Memory Cells generated after vaccination?

Members of the clonal army that remain after the target is gone. They enable a quicker, more robust response if the invader is seen again

Name three different methods to introduce a vaccine target protein (antigen).

• 1. Protein Vaccine (injecting purified protein).

• 2. RNA Vaccine (injecting instructions).

• 3. Vector Vaccine (using a harmless virus to carry instructions).