Chemon. Solution for New Drug Development

Transcription

1 Chemon Solution for New Drug Development

2 Welcome Welcome to Chemon The world is experiencing Bio Revolution, often called the 2 nd 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 2 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, 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 Full Spectrum Service Network

3 History Opened Chemon Analysis Center in Gyeonggi Bio Center KGLP Certificate(KFDA) - Phtotoxicity, Photosensitization Designated by NIER as a Chemical substance test agency History Venture Certificate(SMBA Gyeonggi Office) - New Technology Company KGLP Certificate(KFDA) - Carcinogenicity 3 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

4 About Chemon Solution For New Drug Development Leading Company of Pharmacology/Efficacy & Safety evaluation in Korea 1. 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 4 GLP Certified organization 1. GLP Certification : covers all field 2. Reliability : GLP Facility approved by Korea Food & Drug Association Customer-Oriented & High-Quality Service 1. 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 Security 1. The business tie-up with universal CRO companies 2. Current multinational non-clinical studies achievement About Chemon 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 Full Spectrum Service Network

5 Research Fields 5 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

6 Service of Chemon Service Toxicity Study General Toxicology Single-dose toxicity study 6 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 Full Spectrum Service Network

7 Reproductive Toxicology Fertility and early embryonic development study in rats (Segment and ICH ) Embryo-fetal development study in rats and rabbits (Segment and ICH ) Pre-and post natal development and maternal function study in rats (Segment and ICH ) Service One or two generation studies in rats Assessment of parental exposure, placental transfer, milk transfer Behavioural test in pups 7 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

8 Service of Chemon Service Efficacy Evaluation & Safety Pharmacology Categories Application 8 Safety Pharmacology Anti-cancer Metabolism Digestion Trouble Immunity Nerve System Menopausal Disorder Pollutants Eliminator Internal Organs Beauty & Health Others 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 Full Spectrum Service Network

9 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 Service 9 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

10 Facilities Facilities 10 Preclinical Research Center Address 334, Jeil-Ri, Yangji-Myeon, Cheoin-Gu, Yongin-Si, Gyeonggi-Do, Korea Area 4,899m 2 Gross Area 2,511m 2 Performance Toxicity studies Efficacy studies Clinical & Histopathology test 3 rd FL QAU room, Archive (Samples/Documents), Temporary Date Depository 2 nd FL 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 1 st FL 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 Others 4 th Fl : Freezer, Boiler, Air-conditioner, Water Tank, etc. Outdoor : Oil Tank, Emergency Generator, Infected Animal Breeding Room Gyeonggi Bio Research Center Address 15F, Gyeonggi Bio Center, 864-1, Iui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, Korea Area 607.2m 2 Gross Area 343.2m 2 Performance Analysis service Bioequivalence test Analysis Room Archive(Samples/Documents/Reagents), Balance Room, Hood Room, Analysis Room, Equipment Room, Warehouse Office Room Business Development Department, Management Support Department, CEO s Room, Vice President s Room Full Spectrum Service Network

11 Contact Information Preclinical Research Center 334, Jeil-Ri, Yangji-Myeon, Cheoin-Gu, Yongin-Si, Gyeonggi-Do, , Korea TEL : / FAX : Gyeonggi Bio Research Center 15F, Gyeonggi Bio Center, 864-1, Iui-Dong, Yeongtong-Gu, Suwon-Si, Gyeonggi-Do, , Korea TEL : ~6 / FAX : Contact Information 11 I webmaster@chemon.co.kr Location Seoul Incheon International Airport Suwon Yongin

12 Chemon A company that cares for people and life,