Transcript Aflatoxin B1 metabolic pathway - Chulabhorn Research Institute

Chemoprevention for liver Cancer
Manufacturing Process
of Product
By Ms. Davong Oumavong
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 ”
New Challenge of Natural products
• Including Broccoli sprouted crushed (500 mg )
(Sulforaphane) and Turmaric crushed (450mg)
(Curcumin) combined with Soy Lecithin (50
mg) per box /capsule
Within two formulas
1. 250 cc Soy Milk per 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)
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.
products’ benefits cont.
• Soy milk product
Soy
milk
• 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
I. Set up the Factory
• Find out building factory’s location - far from
community
• Design the building factory and structure and
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 chemicals and analysis laboratory
room, testing animal house and cool house
I. cont.
• Design process of extraction, analysis,
packaging and manufacturing
• Design useful things for personnel - toilet,
changing room, eating room, relaxing room,…
• Design responsibility of personnel
• Licensing the factory to controlling
Agency - Environmental, Industrial, FDA,…
and construct the factory
II.
Finding out sources of medicinal
plants or 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)
II. cont.
• Selecting factories who produce starting
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)
III. Agent Extraction Process
• Substance Extraction – freezing dried
Rhizome ( Curcuma Longa ) and Broccoli
sprouted seeds and crushing
• Design for finished product formula and
their ingredient quantity - capsules and soy
milk with Lecithin
a. QC for raw/starting materials
(Good laboratory practices in factory
laboratory)
1. Purity
- Bacteria contamination
- Toxin contamination
- etc.
2. Quantify for active compound
- % of active agent
IV. Quality Control in Producing process
• Quality Management – training
personnel, equipments / materials,
premises, complaints, internal quality
audit, contract manufacture and analysis/
laboratory testing etc
• Quality control- sanitation & hygiene,
ISO 22000, ISO 17025, Drug GMP
( Safety, effectiveness, Acceptability)
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
Factory Structure
Raw mat.
Storage
room
Synthesis
room
Entrance
Laboratory
room
Drug
formulating
room
Cleaning
room
Packaging
room
Exit
Office
room
Eating room
& relaxing
Storage room
( Finished
Products )
Chem.
Storage
room
Animal
testing
house
Maintenance
Hazardous waste
holding room
Toilet and changing room
Solid waste storage area
Crushed Broccoli
sprouting freezing
dried
Producing Process for capsule
Lecithin and necessary Ingredient 5%
Crushed extract
50 % ( Raw
material )
Turmeric
crushed ( Raw
material)
45 %
Crushed Rhizome
freezing dried
Chemoprevention
compound
Mixing
Coating
1000 mg /capsule
Packaging
Finished
Equipment machines for capsule
producing process
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Freezer
Crush machine
Mixing machine
Capsule machine
Packaging machine
Add
sufficient
water to
batch tank +
K citrate
Producing Procession for soy milk
Add Broccoli
sprouted Crushed
Turmeric crushed
and flavoring
Homogenize
2500 psi 1st stage
and 500 psi 2nd
stage( mixing)
Add stabilizer
mixed 1:15 with
sucrose to water
25 ºC
Heat to 70
ºC
UHT process,
cool to 27 ºC
and pump to
sterile surge
tank
Add soy
protein
isolate and
disperse well
Add soy oil /
Lecithin 5%
Fill sterilized
containers or
packs ( Finished )
Equipment machines for soy milk
producing process
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Tank, surge tank
High shear mixer
Heater
Mixer machine
Freezer
Pump
Packaging machine
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
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.