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!

What is preclinical testing?

In the process of preclinical testing of a compound or biological agent into a drug, the compound involved must go through the testing phase. First, we need to identify potential targets that can treat the disease. Then, a variety of compounds or preparations are screened out. Any compound that has shown potential as a drug for the treatment of this disease needs to be tested for toxicity before clinical testing to reduce the possibility of injury. preclinical testing What is the basis of preclinical testing? According to US Food and Drug Administration (FDA) regulations, a series of tests are required before a new drug is approved for use. In the first stage, basic research determines a hypothetical target for the treatment of a certain disease, and then screens small molecules or biological compounds to discover any substance with the potential to treat the disease. Then, a preclinical research phase followed, before which, as described above, the potential toxicity of the compou

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Inventory of the three major in vitro pharmacokinetic research methods

The metabolic properties of a compound are an essential factor in whether or not it can be used as a drug in the clinical setting, so pharmacokinetic studies of newly synthesized compounds are required in drug development. In vitro incubation with liver microsomes, recombinant CYP450 enzyme lines, and in vitro incubation with hepatocytes are some of the more common in vitro drug metabolism methods. 1. In vitro incubation method with liver microsomes The metabolic stability and metabolic phenotypes of candidate compounds in different species of liver microsomes are good predictors of the metabolic properties of compounds in vivo. They are practical tools for evaluating candidate compounds in the pre-development phase of drug development. Liver microsomes include rat liver microsomes, human liver microsomes, canine liver microsomes, monkey liver microsomes, and mouse liver microsomes. In in vitro incubation of the liver, microsomes are the "gold standard" for in vitro d

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Novel Parkinson’s Therapies Possible with New Mouse Model

Parkinson's disease (PD) is a neurodegenerative disorder that is marked by the accumulation of the protein, α-synuclein (αS), into clumps known as Lewy bodies, which diminish neural health. Now, researchers from Brigham and Women's Hospital (BWH) report the development of a mouse model to induce PD-like αS aggregation, leading to resting tremor and abnormal movement control. The mouse responds to L-DOPA, similarly to patients with PD. The team's study (“Abrogating Native α-Synuclein Tetramers in Mice Causes a L-DOPA-Responsive Motor Syndrome Closely Resembling Parkinson’s Disease”) on the use of this transgenic mouse model appears in Neuron . “α-Synuclein (αS) regulates vesicle exocytosis but forms insoluble deposits in PD. Developing disease-modifying therapies requires animal models that reproduce cardinal features of PD. We recently described a previously unrecognized physiological form of αS, α-helical tetramers, and showed that familial PD-causing missense mutati

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