Toxicology Services

Medicilon's toxicology department has professional teams with rich experience in toxicology studies. We offer high-quality data and rapid turnaround period to support drug discovery and development. Our toxicological studies are conducted in various animal species. The toxicological evaluation from dose design, in-life studies to histology and pathology testing along with toxicokinetics studies are all compliant with GLP or NON-GLP standards. Our study platform is certified as one of the Shanghai Public Service Research Platforms.

Animal Facilities

50,000 Sq. ft. total area
12,500 Sq. ft. for function area
12,500 Sq. ft. for Canine housing: maximum capability for 350 canines
12,500 Sq. ft. for Nonhuman Primate housing: maximum capability for 400 NHPs
12,500 Sq. ft. for Barrier system for Rodent housing: Separate SPF and non-SPF area; maximum capability for 5000 animals of SPF area and 500 animals of non-SPF area
Design and Operation of the facility are under international and Chinese regulations

Drug Preclinical Safety Evaluations (SFDA, FDA GLP Compliance)

Single dose toxicity study
Repeated dose toxicity study
Safety pharmacology study
Genotoxicity study
Reproductive toxicity study
Immunogenicity study
Toxicokinetic study
Topical toxicity study

Drug evaluation research completed from 2008 to 2010
More than 1000 per year preclinical researches have been completed, including single-dose toxicity studies, repeated-dose toxicity studies, topical toxicity studies, toxicokinetic studies and pharmacokinetic studies, now the company has been expanding the safety evaluation to safety pharmacology study, immunogenicity study, genotoxicity and reproductive toxicity study. At present, evaluation and research of several IND packages are being conducted and will be submitted to FDA soon.

Histopathology Capabilities

Routine and special staining techniques
Preparation of slides with high quality
State-of-the-art automated equipment: Slide and cassette printing (Leica) ;Tissue processing (Leica) ; Hematoxylin & eosin staining(Leica)
Professional microscopic review by domestic and international pathologists

Clinical Pathology Capabilities

Hematology
Eukocyte count (total and 5 part differential), Erythrocyte count, Hemoglobin, Hematocrit, Mean corpuscular hemoglobin, Mean corpuscular volume, Mean corpuscular hemoglobin concentration, Absolute and percent reticulocytes, Platelet count, Blood cell morphology
Urinalysis
Volume, Specific gravity, pH, Color and appearance, Protein, Glucose, Bilirubin, Ketones, Blood, Urobilinogen, Nitrite, Leukocyte, Microscopy of centrifuged sediment
Coagulation
Prothrombin time, Activated partial thromboplastin time, Thrombin time, Fibrinogen
Clinical Chemistry

In Vitro Enzyme Activity Assay

Kinases play extensive and important roles in signal transduction and co-ordination of complex functions. Currently, about 300 kinase inhibitors have been approved for marketing, among which receptor tyrosine kinase (RTK) inhibitors are the main ones. Medicilon provides high-quality kinase profile screening and has one-stop kinase research services from assay development, high-throughput screening to selectivity analysis. In addition, Medicilon provides many other enzyme activity screens. Wide Variety Provides 200+ in vitro enzymatic detection methods; 100+ kinases, including CTK, RTK, AGC, CMGC and other kinase families as well as important common mutations Project Flexibility Various types of plates for screening, such as 96 and 384; Multiple flexible kinase profiles, including TK kinase family, CDK kinase family, etc., to meet different customer customization needs. Various Methods Fluorescence detection; Chemiluminescence detection; Absorbance detection LanthaScr...

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Custom Synthesis

Medicilon has synthesized over 10,000 individual compounds from gram to kilogram quantities, and many compounds are synthesized with more than ten synthetic steps. The overall synthesis success rate is over 95%. High quality products from mg to kg scale Reagents, intermediates, building blocks, and scaffolds Preparation of API or reference standards Development of synthetic routes for impurities and metabolites On-site analytical support Product delivered with COA Medicilon offers integrated drug discovery services -- Chemistry, Biology & Preclinical Services

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Fluorescence Probes Synthesis

Medicilon's fluorescent probes and labeling platforms can provide fluorescent probe design and synthesis services for scientific institutions, drug R&D companies, and other customers. Design and synthesis steps Fluorescent probes are tools used to detect, measure and analyze biomolecules, cells and tissues. They achieve these purposes by emitting and receiving fluorescent signals. Medicilon can complete the design and synthesis of fluorescent probes for biomolecules. Selection of target molecules and determination of target. Selection of fluorescent dyes. Design of molecular structure. Synthesize probe molecules. Testing the properties of probe molecules. Custom synthesis Medicilon's fluorescent probes and labeling platforms can provide fluorescent probe design and synthesis services for scientific institutions, drug R&D companies, and other customers. After years of development, Medicilon's fluorescent probes and labeling platforms have accumulated rich experience...

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Shanghai Medicilon Inc.

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