The rDNA Protein Market

By: Lemuel Hermano

THE rDNA PROTEIN MARKET The up and down of the recombinant

DNA industry are enough to give a day trader indigestion. Many fledgling companies fail to bring their product to the marketplace. Numerous products are halted as late as Phase 3 of clinical trials because they either fail to show significant improvement over existing products or they have unintended side effects.

THE rDNA PROTEIN MARKET Movement from Phase 3 to regulatory review

occurs when efficacy has been demonstrated and the FDA (Food and Drug Administration) is tasked to conclude that the product is suitable for patients. The capital investment to set up a production system is substantial and the lead time between development and approval for marketing by the FDA (Food and Drug Administration) is on the average 5 to 6 years. Overall U.S. success rate for rDNA products for the period 1990 to 1997 was 35% (Pavlou and Raicher, 2004).

THE rDNA PROTEIN MARKET And additional obstacle to bringing an

rDNA product to market is the fact that increasing production capability of existing facilities for rDNA products and for monoclonal antibodies is estimated to take about five years and $300-500 million (Powell, 2003)

THE rDNA PROTEIN MARKET However, most prognosticians are

forecasting an imminent flood of new products that will enjoy high demand. In fact, there is concern that this fledgling industry is ill-equipped to address the demand

THE rDNA PROTEIN MARKET . A recent analysis by Keith Carson

(Carson, 2005) and others demonstrated that the manufacturing capability of the industry will be overwhelmed if only a fraction of the antibody products succeed, which are now in various stages of development. The industry may increasingly turn to alternative means of producing the human protein, namely transgenic animals and plants.

Test

1-5 True Or False 1. A recent analysis by Keith Carson (Carson, 2005)

and others demonstrated that the manufacturing capability of the industry will be overwhelmed

2. Movement from Phase 3 to regulatory review occurs when efficacy has been demonstrated

3. For monoclonal antibodies is estimated to take about five years and $350-500 million

4. Overall U.S. success rate for rDNA products for the period 1990 to 1997 was 10%

5. The capital investment to set up a production system and the lead time between development and approval for marketing by the FDA is on the average 5 to 6 years

ANSWER. 6. FDA means? 7. Most ___________ are forecasting an imminent

flood of new products that will enjoy high demand

8. The success rate for rDNA products for the period 1990 to 1997?

9. The up and down of the __________industry are enough to give a day trader indigestion

10. The industry may increasingly turn to alternative means of producing the ___________, namely transgenic animals and plants

Answers1. True2. True3. False4. False5. True6. Food and Drug Administration7. Prognosticians8. 35%9. recombinant DNA10. human protein