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The Capability of Medicilon's Bioanalysis Department was recognized by the National Institutes for Food and Drug Control

2023-02-17
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Medicilon Preclinical Research (Shanghai) LLC (MPR), a subsidiary of Shanghai Medicilon Inc (Medicilon), has recently received the certificate of proficiency testing for "NIFDC-PT-358 Determination of Carbamazepine Metabolic Concentration in Human Plasma" and "Determination of Bevacizumab Concentration in Monkey Serum" organized by the National Institute for Food and Drug Control (NIFDC) and the evaluation results are all "satisfactory"!

Medicilon Bioanalysis Department

Medicilon's Bioanalysis Department, with a laboratory of about 1,500 square meters, has nearly 150 analytical scientists in the field of large and small molecules.  The lab has state-of-the-art equipment, implements the information management, and follows the requirements of FDA/NMPA GLP and GCP regulations.  The services cover various fields such as pharmacokinetics, toxicokinetics, pharmacodynamics, immunogenicity and bioequivalence, providing early screening and development of small molecule drugs, biotechnology drugs, vaccines and biomarkers, as well as preclinical and clinical research at various stages to provide a full range of bioanlysis services.

The state-of-the-art equipment, facilities and management system of Medicilon's large and small molecular bioanalysis department can provide clients with LC-MS/MS, HRMS, ELISA, ECL, FIA, qPCR/ddPCR, ELISPOT, FACS, Enzyme Activity, Cell-based Assay, Multi-Plex Assay and other technical platforms for biological analysis to support the needs of various projects.  Medicilon fully meets the research data requirements for IND declaration and NDA declaration of various drugs, and has extensive experience in the analysis of various small molecule drugs, macromolecular drugs, vaccines, and cell gene therapy drugs.

Medicilon's Bioanalysis Department for large and small molecular has passed the 2022 NIFDC's capability verification, which is an affirmation of Medicilon's ability and strength in the field of bioanalysis.  It is also another recognition of the quality level and technical strength of Medicilon's new drug R&D service system.

In the future, Medicilon will always adhere to the service concept of "innovation-driven, quality first", and utilize the professional technology to help global clients to complete their drug R&D efficiently, to shorten the R&D cycle, to improve the R&D quality, and to reduce the R&D costs.

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