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Semi-synthetic Artemisinin: A New Source of Artemisinin to Reduce Barriers to ACT Access
November 18, 2008London, UK
Presented By Philippe Desjeux, PhD
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iOWH Mission
The Institute for OneWorld Health Develops Safe, Effective, and Affordable
New Medicines for People with Infectious Diseases in the Developing World
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The Partnership
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Project Vision: Semi-synthetic Artemisinin
Increase Increase Access to ACT Access to ACT
CuresCures
Global Health Challenges
(Artemisinin Supply)
SyntheticBiology
(Biotechnology)
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Semi-Synthetic Artemisinin Project Goals
Create a complementary source of non-seasonal, high-quality and affordable artemisinin to supplement the current plant-derived supply
Contribute to stabilizing the price of artemisinin to benefit all stakeholders
Ensure semi-synthetic artemisinin is available to all high-quality derivatizers and ACT manufacturers
Enable millions of people infected with malaria to gain consistent access to affordable, high-quality, life-saving ACTs
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A Second Source Supplements & Stabilizes the Artemisinin Supply Chain
O
O
O
OO
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HHHO
O
H
H
H
Chemistry
ArtemisininArtemisinic Acid
Yeast+
Sugar
Fermentation
DERIVATIVES
ACT Therapy
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O
O
OO
H
HH
Artemisinin
ExtractionCultivation
Months
Days
Controlled Process
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Artemisinin As A Starting Material
Artemisinin
Dihydroartemisinin
Artesunate
Artemether
Artelinate
Arteether
Artemisinic acid
Raw material Defined specifications
Starting materialDefined specifications
API Compendial specifications
GMP manufacturing
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Achievements & GoalsAchievements
• Completed strain engineering to reach productivity targets at bench scale fermenter level
• Transferred technology (fermentation, purification, and chemistry) to manufacturing partner
• Reproduced laboratory data at pilot scale
Goals• Demonstrate chemical comparability between semi-
synthetic and plant derived artemisinin No need for bioequivalence studies
• Process optimization and development of industrial processes suitable for 100,000L scale
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Semi-synthetic Artemisinin Timeline
Process Development and
Scale up
Industrialization
2011 - 2012
Pre-Development
10,000L1000L 100,000L
CommercialProduction
2nd Source of Artemisinin for ACTs
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Market Impact
Supplement botanical supply to support projected increased demand for ACTs
Semi-synthetic artemisinin cost is anticipated to be comparable to the current cost of high quality field production
Semi-synthetic artemisinin will be made broadly available to those derivative and ACT manufacturers who will apply the principle of “no profit, no loss”
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Thank You