Full Spectrum Service Network
Welcom
e he world is experiencing Bio Revolution, often called the 2nd Industrial Revolution. Globally,
new drugs are being made, many of which are based on biotechnology.
In the course of drug development, pre-clinical research is an indispensable step, and new
evaluations are pronounced with the appearance of new bio substances. Pacing with such
global trend, the domestic demand for pre-clinical research is rapidly increasing. At the
same time, the safety demand is also increasing proportionally.
In order to satisfy such nationwide demand, Chemon was set up on January 11, 2000 as
the 1st CRO company in private sector. With ceaseless R&D, our technical level is now
widely recognized as explained with the KGLP Certificate in Carcinogenicity which we won
in March, 2006. With many experts in diverse fields, we now are engaged in the test and
analysis of drug effect along with toxicity test. In cooperation with business partners, we
provide distinctive and one-stop service including clinical research, agency work for diverse
approvals, development and commercialization of new compounds, and so on.
We always do our best to provide our customers with the best quality service. We promise
to continue our effort as a successful partner at the pre-clinical research stage.
Cheol seong Peck, C.E.O
Welcome to Chemon
T
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History
History
Opened Chemon Analysis Center in Gyeonggi Bio Center
KGLP Certificate(KFDA) - Phtotoxicity , Photosensitization
Designated by NIER as a Chemical substance test agency
Venture Certificate(SMBA Gyeonggi Office) - New Technology Company
KGLP Certificate(KFDA) - Carcinogenicity
Designated by MAF as an agrichemical test agency
Venture Certificate(SMBA Gyeonggi Office) - New Technology Company
Completed Yangji Lab and moved into it (Approval by KGLP)
Selected as Inni-Biz A Class
Re-certified as a venture company (SMBA Gyeonggi Office)
KGLP Certificate(KFDA) - Repeated, Reproductive, Immuno, Local
Technology Transfer(Anti-Depressant)
KGLP Certificate(KFDA) - Single Dose, Genetic Toxicology
Selected as an Inno-Biz
Certified as a venture company(SMBA)
Technology Transfer(Allergy Medication)
Chemon Inc. was established
Established an affiliate research institute
2007
2006
2005
2004
2003
2002
2001
2000
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Full Spectrum Service Network
About Chemon
Leading Company of Pharmacology/Efficacy & Safetyevaluation in Korea1. Many experiences of validity test evaluation
2. Maintaining a lot of Cell lines, Fungus and Bacteria for perfect in vitro test
3. Accumulated Know-How and experience in experiment
GLP Certified organization1. GLP Certification : covers all field
2. Reliability : GLP Facility approved by Korea Food & Drug Association
Customer-Oriented & High-Quality Service1. Direct consulting by many different field experts
2. Full service agency that covers from launching new product to registration
in Korea Food & Drug Administration
3. All toxicity studies performed by OECD & ICH Guideline
Universal Competitive Power Security1. The business tie-up with universal CRO companies
2. Current multinational non-clinical studies achievement
● Established as the 1st CRO Company in private sector
● Selected as an Inno-biz company
● Approved as a venture company
● Consultation for New Drug Development, Contract Research Service
● One-Stop Service for new drug development
● Synergetic Effect by the foremost experts in each field
About Chemon
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Solution For New Drug Development
Research Fields
● One-Stop Service from New Compounds to New Drug
- Efficacy Test and Analysis In Early Stage
- Toxicity/Efficacy Study
- Agency Business for Clinical Trials & Relevant Authorization
- Advice on New Drug Development
Research Fields
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Full Spectrum Service Network
Service
Service of Chemon
●Toxicity Study
General Toxicology
Single-dose toxicity study
• Studies performed in rodents and non-rodents (beagle dog)
• Studies using fixed dose, “up-and-down” and other protocols
Repeated-dose toxicity study
• Studies performed in rodents and non-rodents (beagle dog)
• Duration : from DRF and 2-4 weeks up to one year studies
• Routes : oral, intravenous, muscle, subcutaneous, percutaneous
• Toxicokinetics : evaluation of bioavailability from plasma samples
Genetic Toxicology
Microbial reverse mutation assay
• Studies used bacterial stains including Salmonella typhimurium (TA98, TA100, TA1535 and
TA1537) and Escherichia coli (WP2 and uvrA)
Chromosome aberration test
• Studies used Chinese Hamster lung cell line
Micronucleus test
• Studies performed in ICR mouse
• Detects immature erythrocytes with micronucli
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Service
Reproductive Toxicology
• Fertility and early embryonic development study in rats (SegmentⅠand ICHⅠ)
• Embryo-fetal development study in rats and rabbits (SegmentⅡand ICHⅢ )
• Pre-and post natal development and maternal function study in rats (SegmentⅢand ICHⅡ)
• One or two generation studies in rats
• Assessment of parental exposure, placental transfer, milk transfer
• Behavioural test in pups
• Extensive historical database
Immunotoxicology
Active systemic anaphylaxis (ASA)
Passive cutaneous anaphylaxis(PCA)
Skin sensitization test
Carcinogenicity study
• Species and strain : rat (Sprague-Dawley, Wistar, WistarHan, Fisher F344),
mouse (ICR, CDI, B6C3FI, C57BL/6)
• Routes of administration : oral, subcutaneous
• Toxicokinetics : alteration in kinetics over lifetime exposure
Local irritation
• Skin irritation
• Eye irritation
Phototoxic test
• Photosensitization test
• Phtotoxicity test
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Full Spectrum Service Network
Service
Categories
Safety Pharmacology
Anti-cancer
Metabolism
Digestion Trouble
Immunity
Nerve System
Menopausal Disorder
Pollutants Eliminator
Internal Organs
Beauty & Health
Others
Application
in vitro, Allograft, Xenograft
Diabetes, Osteoporosis, Sexual function improvement
Helicobacter, Gastritis, Ulcer
Allergic Trouble, Atopy, Immunity, Anti-inflammation
Memory, Depression, Dementia, Apoplexy
Blood Circulation, Arteriosclerosis, Senile Change,
Anti-Oxidizing Agent, Hyperlipemia
Nicotine, Hangover
Kidney, Liver
Whitening, Wrinkle Care, Skin Protect, Corneous Remedy
Virus / Mold infection, Obesity, Pain, Fever Remedy,
Constipation, Hair Tonic
Service of Chemon
●Efficacy Evaluation & Safety Pharmacology
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Service
●Analysis Service
- Method development and validation
- Stability testing(short or long testing)
- Physico-chemical properties
- Quality Control
- ADME studies
- Method development and validation using HPLC and LC-MS/MS
- Pharmacokinetics
- Pharmacodynamics
- Bioequivalence test
●Clinical and Histopathology
- Haematological test
- Blood biochemistry test
- Autopsy
- Tissue specimens and Histopathologic evaluation
• Microscopic finding/Photomicrograph
• Histopathologic Report
- Team of veterinary pathologists and peer review of pathological diagnostics
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Facilities
Preclinical Research CenterAddress
Area
Gross Area
Performance
334, Jeil-Ri, Yangji-Myeon, Cheoin-Gu, Yongin-Si,
Gyeonggi-Do, Korea
4,899m2
2,511m2
• Toxicity studies
• Efficacy studies
• Clinical & Histopathology test
3rd FL
2nd FL
1st FL
Others
QAU room, Archive (Samples/Documents), Temporary Date Depository
Rodent SPF Breeding Room, Rodent Autopsy Room, Histopathology Room, Clinical
Pathology Room, Reproductive Toxicology Room, Pathology Room, Genetic Toxicology
Room, Efficacy & Pharmacology Room
Behavior Checking Room, Bacterial / Cell Culture Room
Dog Breeding Room, Guinea Pig Breeding Room, Special Animal Experiment Room,
Operation Room, Autopsy Room, Carcass Room, Automatic Control Room, Research
Support Room, PM Room
4th Fl : Freezer, Boiler, Air-conditioner, Water Tank, etc.
Outdoor : Oil Tank, Emergency Generator, Infected Animal Breeding Room
Gyeonggi Bio Research Center Address
Area
Gross Area
Performance
15F, Gyeonggi Bio Center, 864-1, Iui-Dong,
Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea
607.2m2
343.2m2
• Analysis service
• Bioequivalence test
Analysis Room
Office Room
Archive(Samples/Documents/Reagents), Balance Room, Hood Room, Analysis Room,
Equipment Room, Warehouse
Business Development Department, Management Support Department, CEO’s Room,
Vice President’s Room
Full Spectrum Service Network
Facilities
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ContactInformation
Contact Information
Preclinical Research Center334, Jeil-Ri, Yangji-Myeon, Cheoin-Gu, Yongin-Si, Gyeonggi-Do, 449-826, Korea
TEL : +82-31-329-9900 / FAX : +82-31-329-9902
Gyeonggi Bio Research Center15F, Gyeonggi Bio Center, 864-1, Iui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, 443-766, Korea
TEL : +82-31-888-6632~6 / FAX : +82-31-888-6640
http://www.chemon.co.kr I e-mail : [email protected]
Location
Suwon Yongin
11
Seoul
IncheonInternational
Airport