Medicilon's newly added facilities have obtained the GLP certification qualification of the National Medical Products Administration

On April 20, Medicilon Preclinical Research (Shanghai) LLC (MPR), a wholly-owned subsidiary of Shanghai Medicilon Inc. (Medicilon), has obtained the GLP (Good Laboratory Practice) certification of the National Medical Products Administration (NMPA) for the newly added facilities at Nanhui Park. In addition, Medicilon obtained two GLP certification approvals for the reproductive toxicity test (Stage III) and the carcinogenicity test qualification. Medicilon also passed the three-year regular review of NMPA drug GLP.

As of now, the service area of MPR GLP services has been increased from 8 to 9, which are single and multiple dose toxicity studies (rodent), single and multiple dose toxicity studies (non-rodent), reproductive toxicity test (Stage I, II, III), genetic toxicity test (Ames, micronucleus, chromosomal aberration), local toxicity test, immunogenicity test, safety pharmacology test, toxicokinetic test, and carcinogenicity test. The total GLP laboratory area of Medicilon increased from 11,000 square meters to 29,000 square meters. The newly added GLP certification is an important milestone in the 19-year development of Medicilon!

❖Medicilon's Drug Safety Evaluation

Medicilon has a quality management system for drug safety evaluation based on the internationally certified AAALAC quality standard and compliance with international and domestic GLP regulations.Since 2008, we have continued to meet international standards and completed high-quality GLP safety evaluation services, establishing a long-term brand effect. Medicilon can perform systematic evaluation services covering multiple toxicity endpoints and has internationally recognized pathology studies to support our safety evaluation studies.

In this rigorous and meticulous GLP certification inspection, the experts from NMPA highly recognized and praised the management system, scientific research personnel, experimental facilities, instruments and equipment, and the operation and management of projects of Medicilon GLP Laboratory. All the experts unanimously agreed to pass the Medicilon’s GLP test.

GLP is the standard that drug non-clinical safety research must abide by, and it is also the basis for international mutual recognition of drug research data. Medicilon’s wholly-owned subsidiary, MPR, is one of the earliest CRO companies in China to establish the preclinical animal experiment facilities in accordance with international GLP standards, and has obtained the certification of the International Laboratory Animal Assessment and Accreditation Committee (AAALAC) GLP certificate. Medicilon has also met the GLP standard of the US FDA and has rich experience in application for clinical trials in China, the United States, Australia and other places around the world.

Break through the situation with hard work and innovation, and empower R&D with dedication, Medicilon will continue to standardize the quality management of non-clinical drug research, through independent iterative innovation and benchmarking with international cutting-edge technology. Medicilon will also fulfill the responsibility and mission entrusted by the era of new drugs, and empower the development of the pharmaceutical industry!

Medicilon and Binhui Biopharmaceutical Have Reached a Strategic Collaboration to Jointly Draw a New Blueprint for the Development of New Biological Drugs

On March 18, Medicilon and Binhui Biopharmaceutical (Binui Bio) announced a strategic collaboration. The two parties will work together to jointly explore the possibilities in cutting-edge fields such as oncolytic viruses, nucleic acid drugs and protein drugs. Gather and Work Together to Create Advantages Facilitate the Research and Development of Oncolytic Viruses, Nucleic Acids, Proteins and Other Drugs As a one-stop biopharmaceutical comprehensive preclinical R&D service CRO, Medicilon has been developing and accumulating for 20 years, always adhering to the spirit of innovation, and has successfully constructed bi/multi-specific antibodies, ADCs , mRNA vaccines , small nucleic acid drugs , PROTAC , and CGT technical service platform that have helped 421 INDs obtain clinical approval. It is this outstanding achievement that has earned Medicilon wide recognition in the industry and laid a solid foundation f...

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A Nickel-Catalyzed Reductive Alkylation of Aryl Bromides and Chlorides for Sp3-Sp2 Bond Formation

In 2012, a nickel-catalyzed reductive alkylation method of aryl bromides and chlorides was reported. Under the optimized conditions, a variety of aryl and vinyl bromides as well as active aryl chloride can be reductively coupled with alkyl bromides in high yields. The protocols were highly functional-group tolerant and the reactions were not air or moisture sensitive. The reaction showed different chemoselectivity than conventional cross-coupling reactions. Substrates bearing both anelectrophilic and nucleophilic carbon resulted in selective coupling at the electrophilic carbon (R-X) and no reaction occurred at the nucleophilic carbon (R-[M]). The 2010 Nobel Prize in Chemistry was awarded for the Pd-catalyzed cross-coupling, and in the past decade the progress in cross-coupling has not only had a significant impact on academic research but has also influenced the industrial synthetic application. The transition-metal-catalyzed union of nucleophilic organo-boronic acids with elect...

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What is Toxicokinetics?

Toxicokinetics is essentially the study of “how a substance gets into the body and what happens to it in the body”. Four processes are involved in toxicokinetics. The study of the kinetics (movement) of chemicals was originally conducted with pharmaceuticals and thus the term pharmacokinetics became commonly used. In addition, toxicology studies were initially conducted with drugs. However, the science of toxicology has evolved to include environmental and occupational chemicals as well as drugs. Toxicokinetics is thus the appropriate term for the study of the kinetics of all toxic substances. Frequently the terms toxicokinetics , pharmacokinetics , or disposition may be found in the literature to have the same meaning. Disposition is often used in place of toxicokinetics to describe the time-course of movement of chemicals through the body (that is, how does the body dispose of a xenobiotic?). The disposition of a toxicant along with its’ biological reactivi...

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