Chemoprevention for liver Cancer

1. Chemoprevention for liver Cancer Manufacturing Process of Product By Ms. Davong Oumavong

2. 1. Why should we prevent cancer ? Prevention is the most successful of treatment 2. What’s new challenge for prevent liver cancer ? “ Taking compound product of non toxic agents as natural product of food supplementary ”

3. New Challenge of Natural products • Including Broccoli sprouted crushed (500 mg ) (Sulforaphane) and Turmaric crushed (450mg) (Curcumin)combined withSoy Lecithin(50 mg) per box /capsule Within two formulas 1. 250 cc Soy Milkper box, 1-2 boxes / day 2. 1000 mg Capsules,1-2 capsules/ time, 2 time/day (For exactly of their consuming amount will prove on Clinical trial)

4. What are our products’ benefits? • Can prevent all of aflatoxin, HBV and also HCV which induce to liver cancer • Prevent not only liver cancer but also other organs and can improve healthy • Clinically proven- it’s a natural product, has no side effect.

5. products’ benefits cont. • Soy milk product • Good taste, easy to buy and take for children or adult • Low cost, safety and give us more than chemoprevention - Including lecithin, mineral agent, vitamin • Capsule product • Easy to safe, take and transport • alternative challenge for people who do not like to drink soy milk Soy milk

6. I. Set up the Factory • Find outbuilding factory’s location-far from community • Design the building factory and structureand necessary equipments– Follow up WHO Guideline for Good Hygiene Practices, Drug GMP-close system, waste system, enough lighting, water supply system etc • Design storage- for raw materials, finished products and chemicalsand analysis laboratory room, testing animal house and cool house

7. I. cont. • Design processof extraction, analysis, packaging and manufacturing • Design useful things for personnel- toilet, changing room, eating room, relaxing room,… • Design responsibilityof personnel • Licensing the factory to controlling Agency-Environmental, Industrial, FDA,… and construct the factory

8. Finding out sources of medicinal plantsor raw materials • Find out location of good soil for cutural control and supply to production -need Good Agricultural Practices ( GAP) and Good Harvesting Practices (GHP)

9. II. cont. • Selecting factories who producestarting materials / intermediate / bulk /seeds – high quality of goods and has enough for producing supply ( - Broccoli seed and Soy Lecithin / Bean may be buy from companies, Curcuma Longa Rhizome can also plant ( in Thailand or Laos) or buy from Indian Company)

10. III. Agent Extraction Process • Substance Extraction– freezing driedRhizome ( Curcuma Longa ) and Broccoli sprouted seeds and crushing • Design for finished product formula and their ingredient quantity - capsules and soy milk with Lecithin

11. a. QC for raw/starting materials(Good laboratory practices in factory laboratory) • Purity - Bacteria contamination - Toxin contamination - etc. • Quantify for active compound - % of active agent

12. IV. Quality Control in Producing process • Quality Management – training personnel, equipments / materials, premises, complaints, internal quality audit, contract manufacture and analysis/ laboratorytesting etc • Quality control- sanitation & hygiene, ISO 22000, ISO 17025, Drug GMP ( Safety, effectiveness, Acceptability)

13. IV. cont. • Producing Control -labeling, clean up, testing lab, toxicology testing, batch product record, documentation, batch control & release • Instruction Product - place / house, cleaning control, good storage practice • Apply to FDA for registration/ licensing

14. Factory Structure Raw mat. Storage room Synthesis room Entrance Cleaning room Laboratory room Drug formulating room Chem. Storage room Animal testing house Packaging room Exit Office room Storage room ( Finished Products) Maintenance Hazardous waste holding room Eating room & relaxing Toilet and changing room Solid waste storage area

15. Crushed Broccoli sprouting freezing dried Producing Process for capsule Lecithin and necessary Ingredient5% Crushed extract 50 % ( Raw material ) Coating 1000 mg/capsule Chemoprevention compoundMixing Turmeric crushed ( Raw material) 45 % Packaging Crushed Rhizome freezing dried Finished

16. Equipment machines for capsule producing process • Freezer • Crush machine • Mixing machine • Capsule machine • Packaging machine

17. Producing Procession for soy milk Add sufficient water to batch tank + K citrate Add soy protein isolate and disperse well Add stabilizer mixed 1:15 with sucrose to water 25 ºC Add Broccoli sproutedCrushedTurmeric crushed and flavoring Add soy oil / Lecithin 5% Heat to70 ºC UHT process, cool to 27 ºC and pump to sterile surge tank Homogenize 2500 psi 1st stage and 500 psi 2nd stage( mixing) Fill sterilized containers or packs ( Finished )

18. Equipment machines for soy milk producing process • Tank, surge tank • High shear mixer • Heater • Mixer machine • Freezer • Pump • Packaging machine

19. Summary • Every process of manufacturing was done by following Good Development, Marketing and Ethic concern of New Product • Response to finished product quality, might pass International Standard for Quality Control , Safety to health and can reduce liver cancer

20. Thank you

21. Broccoli sprouting process • Seeds not treated with pesticides • Seeds surface-sterilized by a 1-min rinse in 70% ethanol, a 15-min exposure to 1.3% sodium hypochlorite containing 0.001% Alconox detergent, • and exhaustive rinsing with sterile distilled water. • The broccoli (Brassica oleracea var. italica) cultivar used was SAGA, • unless stated otherwise. • Sprouts were grown without added nutrients either aseptically on 0.7% agar or in inclined perforated trays (35 × 40 cm) • watered with four 15-s gentle spray cycles per h. • All sprouts were grown with a 16-h light and 8-h dark photoperiod • and a corresponding 25/20°C cycle for agar-grown sprouts or a constant 25°C for tray-grown sprouts. • Sprouts were rapidly and gently collected from the surface of the agar or spray tray immediately before extraction to minimize hydrolysis of glucosinolates by endogenous myrosinase. • Mature and frozen vegetables were obtained from local supermarkets. Plants not extracted on the day of collection were stored at 80°C.