Recombinant DNA Drugs
September 8, 2009

 

First Warm UP Assignment Due Thursday8/30 at Noon -
Go to Oncourse Test and Survey Tool!

 

I. Recombinant DNA Technology: At the heart of most biotechnology techniques is...the gene. Manipulating genes and making gene-based products is what Biotechnology is all about! (at least until we understand more about the genome!!!) We won't be able to go too in depth about genes and molecular biology, but here are the basics:

 

1. A (real quick) review: What is a gene?

A. Anatomy of a Eukaryotic, Protein-encoding Gene (Figure; Print out)

B. Pre-mRNA processing and alternative splicing

2. Recombinant DNA Technology: the standard tools for cutting, pasting, and analyzing DNA

A. Plasmids - the "vehicle" for cloning Figure:

B. Restriction enzymes - "cut and paste" DNA Figure

C. Host cells - to carry and replicate the cloned DNA Figure

 

II. Biotech's First Wave: Recombinant DNA Drugs - Homework!

 

The notes below are in OUTLINE form and require you to do a bit of homework (~2 hours of time before class). For each drug listed below, go to the link provided and read about the drug to determine:
(1) The Protein Product: what human protein is formulated as the drug?
(2) Indication: why is the drug prescribed and what it does it do in the body?
(3) Other notes: Alternate forms of this drug, competing products on the market, "the dark side" scandals, etc. More on this in class, but see if you can pick up any info beforehand.

It may be more difficult to get the info for some drugs than others - but get as much info as you can before class. This might be a great time to get to know your fellow students...split up the work...start thinking about a team project...!

 

Important Disclaimer: This is certainly not an inclusive list - but represents many of the best rDNA drugs on the market today. For an almost complete list of drugs in the pipeline, see List of biotech drugs in development Oct 2006 (rDNA and Monoclonals are in bold type). We will focus mainly on Drug Biotech companies (started as biotech firms) rather than the "Big Pharma" companies (Pfizer, J&J, Merck, Abbott, Wyeth, Bayer, Roche, etc) - many of which license biotech drugs and may even have developed a few of their own, but in general, aren't successful because of their biotech drugs (Lilly is an exception that we will discuss).

 

 

I. Amgen: (Nasdaq: AMGN)

 

	Protein Product: what human protein is formulated as the drug	Indication: why drug is prescribed and what it does in the body	Other notes (Alternate forms of this drug, competing products on the market, etc)
1:Epogen /Procrit
2. Aranesp
3: Neulasta
4. Infergen:

 

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II. Biogen (Nasdaq: BGEN)
rDNA products on the Market

	Protein Product: what human protein is formulated as the drug	Indication: why drug is prescribed and what it does in the body	Other notes (Alternate forms of this drug, competing products on the market, etc)
1. Avonex
2. Intron A
3. Engerix-B/ Recombivax
4. Amevive

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III. Chiron ( a Novartis partnership) recently acquired by Novartis, agrements with Bayer...

	Protein Product: what human protein is formulated as the drug	Indication: why drug is prescribed and what it does in the body	Other notes (Alternate forms of this drug, competing products on the market, etc)
1. Betaseron
2. Proleukin
3. Regranex

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IV. Genentech (NYSE: DNA)

rDNA products on the Market:

>

	Protein Product: what human protein is formulated as the drug	Indication: why drug is prescribed and what it does in the body	Other notes (Alternate forms of this drug, competing products on the market, etc)
1. Activase 1a.CathFlo Activase:
2. TNKase
3. Pulmozyme
4: Neutropin

 

Optional but interesting to scan (at least the beginning) if you are interested in how patents can be issued on human gne sequences and proteins!
1. US Patent 4,634,677, Issued January 6, 1987 to Goeddel and Genentech "Plasmid capable of expressing human growth hormone"
2. US Patent 4,670,393; Issued June 2, 1987 to Peter Seeburg and Genentech "DNA vectors encoding a novel human growth hormone-variant protein "
3. US Patent 5,424,199, Issued June 13, 1995 to Goeddel and Genentech "Human Growth Hormone"

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V. Eli Lilly: (NYSE: LLY)
rDNA products on the Market:

	Protein Product: what human protein is formulated as the drug	Indication: why drug is prescribed and what it does in the body	Other notes (Alternate forms of this drug, competing products on the market, etc)
1. Humulin Chart comparing Time Activity Profiles (go here)
1a: Humulin pens 1b: Humalog: 1c: Humalog Mix
2. Humatrope
3. Xigris
4. Forteo

5. Byetta

Gila Monsters!?!?

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And one from Merck:

	Protein Product: what protein is formulated as the drug	Indication: why drug is prescribed and what it does in the body	Other notes (Alternate forms of this drug, competing products on the market, etc)
1. Gardasil:

 

OK, that's all!

Objectives:
1. Know all the "parts" of a eukaryotic gene
2. Describe how restriction enzymes function to create recombinant DNA
3. Describe how bacteria can be used to produce eukaryotic proteins

For each of the companies studied, be able to list:
1. The Protein Product: what human protein is formulated as the drug?
2. Indication: why is the drug prescribed and what it does it do in the body?
3. Other notes we will discuss in class (Alternate forms of this drug, competing products on the market, "the dark side", etc)
4.You do not need to know who licenses what drug to what company, the annual revenues, the company history, or the dates of FDA approval...
5. Material on the readings may end up as exam material - so read those carefully!

ARE YOU getting a feel for a life-saving drug that YOU and your fellow students just might develop in the near future? HOPE SO!

.........................................................Copyright Kathleen A. Marrs 2009