1. Prepurification of Paclitaxel by Micelle and Precipitation
Department of Chemical Engineering,
Kongju National University, Kongju , South Korea
Thank you for chairperson. My name is jong kwan park.
This study was carried out to synthesize of Fe-Si Alloy Nanoparticles
by Gas Phase Reaction.

2. Paclitaxel ? General name : Paclitaxel – Anticancer drug
Chemical formula : C47H51NO14 (M.W. : 853.9)
Trademark : Taxol(BMS), Genexol(Samyang Genex, Korea)
1992, FDA Approval of Ovarian Cancer
1994, FDA Approval of Breast Cancer
1997, FDA Approval of Kaposi’s Sarcoma
World Market Size : $1.4 Billion in 1998
Insoluble in water

3. Comparison of Paclitaxel Production Methods
Extraction
Semisynthesis
Plant Cell Culture
Needle (Yew tree)
10-DAB Taxol
Taxotere
Plant Cell Induction
Bioreactor
Advantages
Bark (Yew tree)
Inconsistency
High Cost
BMS (1995)
Rhone-Poulenc
Samyang Genex
BMS-Phyton
Mitsui
BMS
China

4. Traditional Purification Methods
Solvent Extraction
Paclitaxel Purity < 0.5%
Removal of Polar Impurities
Prepurification
Removal of Waxy Compounds
Paclitaxel Separation
Crude Paclitaxel
Paclitaxel Purity < 1∼4%
: Very low!
Purification

5. Research Objectives Problems of Traditional Purification Methods
Using Chromatography in prepurification step
The purity of crude paclitaxel is very low in prepurification step
: Increase solvent usage, size and complexity of HPLC operation
Impractical for Scale-up
Objectives
Improvement of traditional purification process
To obtain high purity of crude paclitaxel for final purification
To develop a new prepurification method for mass production of paclitaxel

6. Scheme of Prepurification Process
Biomass
Extraction
Aqueous phase
Polar
Nonpolar
Precipitation
Micelle Formation
Crude Paclitaxel for Purification
Purification

7. Extraction conditions
Effect of extraction time on paclitaxel recovery

8. Prepurification of paclitaxel
Removal of nonpolar impurities by micelle formation and phase separation
Phase Separation
Micelle formation
Nonpolar impurities
Solvent phase
Aqueous phase
Surfactant
Solvent : MtBE/Hexane(1/1)

9. CONCLUSION
Results obtained for the extraction/prepurification of paclitaxel from Biomass (200g)
Process step
Paclitaxel(mg)
Paclitaxel purity(%)
Biomass 39 -
MeOH extract＊ 38
<0.5
MtBE extract 32
29.4
Precipitation
(Crude paclitaxel) 31
65.8
＊Four times extraction

10. 생물공정의 scale-up 및 제품화 연구
원료의약품(APIs; active pharmaceutical ingredients)의 경우 최종 제품의 순도와 더불어 불순물의 농도, 잔류용매 함량, 제품형태(결정 또는 무정형), 수분 함량,
Endotoxin 함량 등을 고려한 제품화 연구를 수행하고 있다.
Scale-up 및 제품화 연구
항암제 Paclitaxel 잔류용매 제거 및 Morphology 조절 개념