Service Overview

The panel based on the clear target refers to the experimental method based on the molecular level and the cellular level, using the microplate form as the experimental tool carrier, using the automated operating system to execute the experimental process, and collecting the experimental result data with sensitive and fast detection instruments. The computer analyzes and processes the experimental data, detects tens of millions of samples at the same time, and supports the technical system of the whole system with the corresponding database.

Service Content

Method development and methodological validation for macromolecular bioanalysis

• Development, transfer, optimization and validation of immunoassay methods for the determination of drug concentrations in biological matrices
• Develop optimized and own validated immunoassay methods such as Adalimumab, Bevacizumab, Trastuzumab, Pertuzumab, Antibody Drug Conjugates
• The Medicilon Macromolecular Biology Laboratory can quickly and efficiently complete methodological confirmation in a short period of time to support the needs of potential projects

Service Process

• The laboratory implements comprehensive information management, and uses the verified laboratory information management system (Watson LIMS 7.2) to establish a complete sample management chain and experimental data processing, tracking and storage chain;
• SensaTronics temperature monitoring system;
• Validated WinNonlin software for data analysis;
• The data is accepted by FDA and NMPA, providing biotechnology drug analysis services that fully meet the requirements of FDA/NMPA/OECD GLP regulations;
• Independent small molecule bioanalysis platform and biotechnology drug analysis platform;
• With SpectraMaxM4/M5/i3×, MSD, Luminex, Biacore 8K, Envision, Gyrolab, ABl7500qPCR and other comprehensive and multifunctional technology platforms;
• Flexible use of ELISA, ECL, IP, Co-IP, qPCR, FACS, Elspot, enzymology and other methods to support cutting-edge biological drugs, including proteins, antibodies (monoclonal antibodies, bi- or multispecific antibodies, antibody fragments), Early development of ADCs, peptides, nucleic acids, vaccines and cell gene therapy drugs, as well as preclinical and clinical research.
• Develop and verify analytical methods for different targets, such as CD-4, CTI-4, PD-1, PD-L1 and T-DM1 analog ADC, etc., support PK/TK/immunogenicity (TotalADA, Nab)/ Analysis of biomarkers/cytokines etc.

Service Advantage

• Development and methodological validation of immunoassay methods
• Analysis of proteins, antibodies, ADCs, peptide drugs, vaccines, cell and gene therapy products, etc.
• Screening and analysis of biomarkers, cytokine detection
• Antidrug Antibody (ADA) Immunogenicity Test Vaccine Determination
• Clinical Sample Bioanalysis
• Support PK pharmacokinetics, TK toxicokinetics, tissue distribution test, IND declaration

Representative Case

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