What is CRO,CMO,CDMO

❖ Contract Research Organization CRO

Contract Research Organization, referred to as CRO, mainly provides drug discovery, preclinical research, clinical trials and other new drug R&D contract research services for multinational pharmaceutical companies and pharmaceutical companies. At present, biomedical R&D outsourcing has gradually become an indispensable link in the pharmaceutical industry chain and plays an important role in the industrial structure.

❖ Medicilon’s Preclinical Research Services

Medicilon is a Preclinical Research Outsourcing (CRO) company. With our more than 10 years experience on preclinical research services, we dedicated to provide our clients with customized preclinical services program in drug metabolism, pharmacokinetics, efficacy studies, and toxicology. We provide our clients a high-quality data and rapid turnaround time to support their drug development, preclinical studies and clinical research and to help them to select the most valuable drug candidates into clinical trials stage.

Medicilon's preclinical research services consist in three major parts: pharmacokinetics, disease transplantation models and drug safety evaluation. Our preclinical research services cover all of the aspects including design, in vivo studies, sample analysis, professional data analysis, IACUC review, and the preparation of application materials.

❖ Contract Manufacturing Organization CMO

Pharmaceutical CMO mainly accepts the entrustment of pharmaceutical companies to provide customized production services, providing process development, formulation development, clinical trial drugs, chemical or biosynthetic API production, intermediate manufacturing, preparation production (such as powder, injections) and packaging services.

❖ Contract Development and Manufacturing Organization CDMO

It is an institution that mainly provides multinational pharmaceutical companies and biotechnology companies with customized R&D and production services such as process R&D and preparation, process optimization, scale-up production, registration and verification batch production, and commercial production of pharmaceuticals, especially innovative drugs.

The value chain extension of the CDMO industry is the future development direction of CMO enterprises.

Medicilon will plan to establish a CDMO service platform to engage in the research and development, process optimization and large-scale production of new drugs in the preclinical and clinical research stages, new marketed raw materials, generic drugs and cGMP standard intermediates, providing customers with chemical and drug production and control CMC solutions for integrated services.

❖ Medicilon’s CDMO Services

Medicilon has constructed the GMP Drug Products Pilot Plant to meet the rising needs for innovative medicine R&D, production, packaging, inspections and stability tests. We are aiming for qualified CDMO services for clients with requirements for the development of innovative medicine.

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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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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Pharmacokinetics Services

Pharmacokinetics Services Our pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, ranging from small molecules to large molecules, such as protein and antibody. The animal species involved in our services are non-human primate, canine, mice, rat, rabbit and hamster. Meanwhile, non-human primate experimental platform and isotope platform for protein/antibody are certified by the Shanghai government. Preclinical Pharmacokinetics Method development and validation (GLP,Non-GLP) Bioanalysis Pharmacokinetics (Tumor bearing rodents, Bioavailability, Crossover studies, Cassette (N in 1) dosing and analysis, effects of gender on pharmacokinetics, BBB penetration ) Stability in vehicles and plasma Drug interaction studies In vitro metabolic stability CYP 450 inhibition Plasma protein binding studies Distribution studies Excretion studies Prediction an...

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Shanghai Medicilon Inc.

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