• Azithromycin o Used to treat certain infections caused by bactera,

such as bronchitis, pneumonia, STDs, and infections of the ears, lungs, skin, and throat. This antibiotic, known as a macrolide antibiotic, works by stopping the growth of bacteria. Azithromycin was discovered in 1980 by a team of researchers at the Croatian pharmaceutical company, Pilva. Azithromycin is made from bacteria.

• Amoxicillin

o Used to treat certain infections caused by bacteria, such as pneumonia, bronchitis, honorrhea, infections of the ears, nose, throat, urinary tract, and skin. Like azithromycin, amoxicillin works by stopping the growth of bacteria. Amoxicillin was discovered in 1972 by scientists at Beecham Research Laboratories, located in the United States. Amoxicillin is made from bacteria.

• Tetracycline

o Used to treat bacterial infections including pneumonia and other respiratory tract infections as well as those caused by acne, infections of skin, genital and urinary systems. It is apart of a class of medications called tetracycline antibiotics, and works by preventing the growth and spread of bacteria. Tetracycline is made from bacteria.

• Ciclosporin

o Used as an immunosuppressant. It’s widely used before an organ transplant to reduce the activity of the immune system, which reduces the risk of organ rejection respectively. Ciclosporin was islated from the fungus Tolypocladium inflatum by Sandoz scientists in Hardangervidda, Norway in 1969.

Aspirin

• Plant: willow tree bark • When discovered: 460 B.C. –

377 B.C.; developed in 1853 • How drug is used in

medicine: to prevent heart attacks, strokes, and blood clot formation; for pain

relief Beano

• Plant: Aspergillus niger (fungus)

• When discovered: 1990

• How drug is used in medicine: used to reduce gas in the digestive tract; reduces bloating and

improves digestion. Quinine

• Plant: cinchona tree bark • When discovered: 17th century • How drug is used in

medicine: fever reducer, pain killer, anti-inflammatory, anti-malarial

Caffeine

• Plant: coffee plant • When discovered: 1820 • How drug is used in

medicine: stimulant

Cocaine

• Plant: coca plant • When discovered:

1855 • How drug is used

in medicine: stimulant

Steroidogenesis: the biological process by which steroids are generated from cholesterol and transformed into other steroids.

• Products of steroidogenesis o Androgens

Testosterone o Estrogens and progesterone o Corticoids

Cortisol Aldosterone

Steroids include estrogen, cortisol, progesterone, and testosterone. Estrogen and progesterone are made primarily in the ovary and in the placenta during pregnancy, and testosterone in the testes. Testosterone is also converted into estrogen to regulate the supply of each, in the bodies of both females and males. Certain neurons andglia in the cerntral nervous system express the enzymes that are required for the local synthesis of pregnane neurosteroids. The rate-limiting step of steroid synthesis is the conversion of cholesterol to pregnenolone, which occurs inside the mitochondrion.

Danazol is a derivative of the synthetic steroid ethisterone, a modified testosterone.

• Before becoming available as a generic drug, Danazol was marketed as “Danocrine” in the U.S.

• It was approved by the FDA as the first drug to specifically treat endometriosis, a gynecological condition, in the early 1970s.

• Although it’s an effective drug, its use is limited by its masculinizing side-effects.

• Danazol inhibits ovarian steroidogenesis resulting in a decreased secretion of estradiol (estrogen) and may increase androgens (testosterone), which help to balance the hormones within the endometrius (uterus lining).

Chemical formula for Danazol (modified testosterone).

Chemical formula for testosterone hormone (steroid).

Introduction

Target

Discovery

Lead

Optimization

Screening and Hits to

Leads

Target

Validation

Assay/Test

Development

Development

Clinical Trials

NDA Market

Typical Drug Development

Simplistic way of summing up the FDA Drug Approval Process

The more complicated way of summing up the FDA Drug Approval Process

Large Scale Bioreactors vs. Small Scale Bioreactors

• Complex design o Moving media (moving

bed biofilm reactor, MMBR)

o Packed bed o Fibrous bed o membrane

• Under optimum conditions, the microorganisms or cells are able to perform their desired function with a 100% success rate

• Fouling can harm the overall sterility and efficiency of large bioreactors that aren’t properly cleaned

• Produces a large amount of cell tissue

• Simple design, less efficient

o Petri dish o Agar gel o Flask

• Smaller amount of cell tissue produced

• Easily contaminated • Doesn’t need to be

monitored as closely as large-scale bioreactor, due to smaller amount of samples.

Both are devices/systems meant to grow cells or tissues in the context of cell culture. These devices are

developed for uses in biochemical engineering.

Okay, so let’s say I was in charge of a team of researchers at a pharmaceutical company that decided they wanted to find a cure to cancer. Where would I start? Being a vegetarian, I am highly aware of the numerous health risks that I easily dodge due to the fact that my limited diet is made up of healthy fruits, vegetables, and herbs that scientists have proven to have cancer-freeing capabilities. The most promising, in my opinion, would be the findings on dry green tea leaves. I happen to be a huge lover of green tea, but little did I know, the dry green tea leaves that green tea is derived from, has these antioxidants called polyphenols. Polyphenols, as studies have shown, are capable of preventing cancer cells from splitting. In dry green tea leaves, polyphenols make up about 40% of the structure (by weight). With these findings, scientists suggest that, if put to proper use, the antioxidants from these dry green tea leaves can reduce the risk of cancer of the stomach, lung, colon, rectum, liver and pancreas. So my plan would be to extract the antioxidants from these green tea leaves through genetic engineering, isolate the antioxidants, have them injected into a well known antibiotic, then expose the newly created antibiotic with green tea leave extract, to a number of different bacterial cultures that have been injected with different types of cancer cells. Sounds confusing? Here’s a couple of diagrams to make it easier to understand.

Making An Antibiotic

Set up a large scale bioreactor.

Add enzyme that will help break down the molecular structure of the leaves.

Add another enzyme that will break down the antioxidants

Crush dry green leaves in a crucible with mortar.

Extract the polyphenols that make up 40% of green tea leaves

Collect sample of dry green leaves.

Make lots of antibiotic solution

Let the elements settle. Now you have your antibiotic.

Take the extract(s) and add them to the antibiotic in the bioreactor

Making the Bacterial Cultures

• You will need the following types of cells o Stomach o Lung o Colon o Rectum o Liver o Pancreas

Isolate the cancer-causing gene for each type of cell (ligation)

Allow the bacteria to grow on the plate.

Insert genetically engineered plasmids into separate bacterial colonies, indicated by labeled petri dishes

Insert the isolated genes into respective plasmids (vectors)

The newly grown bacteria should exhibit the same characteristics as the plasmids

You should now have bacterial colonies for each type of cancer cell

Once you’ve prepared the antibiotic and the bacterial colonies, it’s easy sailing from there. Place a couple of drops of antibiotics in each of the labeled petri dishes and incubate the samples. In a couple of days, check out the samples to see which ones (if any) responded to the antibiotic that was derived from the dry green tea leaves. In this experiment, my path would be to determine which type of cancer cells, dry green tea leaves responds better towards (in terms of killing or stopping the growth of the cells). Once that is determined, I would work from there on trying to develop a drug, using genetically engineered extracts from the dry green tea leaves, that would help stop the spread of cancer(s) throughout that part of the body (depending on the location of determined cancer cells). Right now, my plan seems very elementary, but of course, I have to start somewhere. Some obstacles will include handling the carcinogens of course, making sure the environment is sterile enough to handle the procedure, making sure the antioxidants are the ONLY thing that’s being taken out of the tea leaves, making sure the RIGHT antioxidants are being extracted, etc. There are lots of things that could go wrong with this procedure, even when working with a large bioreactor, because its handling carcinogens, which makes for a dangerous environment, especially since the cells will be alive (I presume). Also, we would be dealing with enzymes, which are very sensitive to their surroundings. Temperatures, and other physical aspects will have to be ideal in order to ensure this lab run successfully. Still, I think my plan could work; it’s simple, yet determinative. If everything were to go diligently, and smoothly, it would be very effective in determining which cancer cells react more to the antioxidants.