Shanghai Medicilon Inc.

  Cell & gene therapy has developed by leaps and bounds in recent years, providing the possibility for many refractory diseases.  With the rapid development of gene transduction and modification technology, delivery vector system, cell culture technology and other technology, breakthroughs have been made in cell & gene therapy, providing a new treatment concept and train of thoughts. Medicilon's preclinical research services cover pharmacodynamic research,  drug safety evaluation , pharmacokinetic research, bioanalysis, etc.  The establishment of a complete gene therapy R&D platform can provide one-stop services for research on pharmacological efficacy, biodistribution and safety evaluation of cell and gene therapy products. Medicilon has established a one-stop research platform for the preclinical research and development of cellular immunotherapy drugs, covering a variety of immunotherapy methods including CAR-T, TCR-T, CAR-NK and TIL cells, etc.  Using a wealth of an

  What is General Pharmacology Research? General Pharmacology research refers to the study of extensive pharmacological effects of new drugs other than the main pharmacological effects. It mainly studies the effects of drugs on the spirit, nervous system, cardiovascular system, respiratory system, and other systems. General Pharmacology Research of New Drugs is divided into three categories, namely Primary Pharmacodynamic, Secondary Pharmacodynamic and Safety Pharmacology. In addition, additional and/or supplementary studies on safety pharmacology (Follow-up and Supplemental Safety Pharmacology Studies) may be required according to experimental requirements. Safety pharmacology is mainly to study the potential undesired adverse effects on physiological functions of drugs at doses within or above the therapeutic range, that is, to observe the effects of drugs on the central nervous system, cardiovascular system, and respiratory system. Additional and/or supplementary safety pharmaco

  Many impurities in drugs can produce toxic and side effects, which is a crucial factor affecting the   safety and effectiveness of drugs , especially genotoxic impurities that can cause serious harm to human health with minimal exposure. Therefore, to ensure API quality and preparations, Genotoxic impurities are a class of impurities that must be paid attention to in the drug synthesis process. Genotoxic impurities from chemical reagents, chemical synthesis, and reaction are involved in all aspects of the drug synthesis process and the subsequent stability and possible degradation of the drug, which is a complex process. For potential carcinogenic or mutagenic substances and impurities with warning structures, the Ames test can generally be used to test the mutagenic ability of impurities. The Ames test is short-term in vitro test method for preliminary screening of the mutagenicity of chemical substances by using the properties of the reverse mutation of the histidine auxotrophic mu

  The   preclinical services   that Medicilon offers focus on  preclinical pharmacokinetic   and   drug safety assessment (evaluation)   for foreign and domestic clients.     Preclinical Drug Safety Testing  : In vitro and in vivo testing to determine if the drug is safe enough for human testing. OUR SERVICES:   ❖ Single dose  toxicity test  (rodent and non-rodent)   ❖ Repeated dose toxicity study (rodent and non-rodent)   ❖ Safety pharmacology test : telemetry and non-telemetry to monitor the electrocardiogram and respiration of dogs and monkeys, rats FOB    ❖ Genotoxicity tests   ❖ Reproductive toxicity test   ❖ Immunogenicity test    ❖ Toxicokinetic    ❖ Partial toxicity test Preclinical Safety Testing Requirements Selection of the  relevant animal species ; Age; Physiological state; Dose, route of administration, and treatment regimen; and Stability of the test material under the conditions of use. Platform The technical service platform of evaluation of biotech drug safety on non-

  1 .  Preclinical drug research (1) Pre-clinical research content 1. Literature research includes drug name and naming basis, the purpose and basis of the topic. 2. Pharmacy research. Raw material technology research, formulation prescription and technology research, confirmation of chemical structure or component test, drug quality test, drug standard drafting and description, sample inspection, auxiliary materials,  stability test , packaging material and container related test, etc. 3.  Pharmacology  and  Toxicology Research . General pharmacology tests, main pharmacodynamic tests,  acute toxicity tests , long-term toxicity tests, allergic, hemolytic and local irritation tests, mutagenicity tests,  reproductive toxicity tests , carcinogenic toxicity tests, dependence tests, animals  Pharmacokinetic tests , etc. The  drug safety evaluation  research must implement the “Pharmaceutical Non-Clinical Research Quality Management Standards” ( GLP ) preclinical study 2. naming of drugs 1.