Medicilon's Preclinical Bioanalysis

Biotechnology drugs are known as one of the most promising fields in drug research and development in the 21st century. In recent years, more and more drug development has focused on this, and its bioanalysis has therefore attracted more and more attention.

Medicilon’s preclinical bioanalysis service team is composed of nearly 20 experienced technical personnel, which can provide domestic and foreign customers with better quality, greater throughput and higher efficiency bioanalysis services.

Medicilon’s preclinical biological analysis service department has a professional scientific research team, the analysis laboratory is equipped with advanced instruments and equipment, and a lot of new instruments have been added, such as the gold standard instrument for immunogenicity analysis-US MSD electrochemiluminescence immunoassay Analyzer etc.

The laboratory implements comprehensive information management, and has established a complete sample management chain and experimental data processing, tracking and storage chain with the aid of the verified laboratory information management system (Watson LIMS 7.2), which can provide customers with global quality service. Implementation of information management, experimental research meets the requirements of FDA/NMPA GLP standards, service content covers pharmacokinetics, toxicokinetics, pharmacodynamics, immunogenicity and bioequivalence and other research aspects, providing customers with small molecule drugs , Screening and development of biologics, vaccines and biomarkers, as well as preclinical and clinical research.

At present, most of the advanced treatment methods for major diseases in the world are related to biotechnology drugs, including tumor immunotherapy, which has been receiving wide attention recently. Antibody drugs, genetically recombinant protein drugs, vaccines, and other biotechnological drugs have shown remarkable effects in the treatment and prevention of diseases, which have attracted the attention of governments all over the world. Since the first monoclonal antibody drug entered the market in 1986, more and more pharmaceutical companies have been developing new biotechnology drugs. Among them, pre-clinical bioanalysis is an important link in the early stage of research and development, which is used to evaluate and explain pharmacokinetics, The scientific basis for research on toxicokinetics, pharmacodynamics, immunogenicity and bioequivalence.

Accurate and reliable analysis methods and true and effective data analysis are an integral part of the laboratory quality system. The preclinical bioanalysis department of Medicilon provides professional technical services in full compliance with FDA/CFDA GLP standards to support the screening and development of protein drugs, antibody drugs, vaccines and biomarkers, as well as preclinical and clinical research.

Preclinical Bioanalysis of Macromolecular Drugs

Medicilon’s preclinical bioanalysis department can provide FDA/NMPA GLP-compliant macromolecular drug bioanalysis services to support the screening and development of protein drugs, antibody drugs, vaccines and biomarkers, as well as preclinical and clinical research.

Macromolecule bioanalysis method development and methodological confirmation

Develop, transfer, optimize and validate immunoassay methods for the determination of drug concentration in biological matrices;
Develop optimized and have a variety of monoclonal antibodies (adalimumab, bevacizumab, trastuzumab, pertuzumab, etc.) and validated immunoassay methods for antibody-conjugated drugs

Protein, antibody, peptide and drug analysis and detection

Bioequivalence test
Pharmacokinetics, toxicology and immunogenicity tests
Radiolabeling (C14, H3, I125) and tissue distribution and pharmacokinetic research

Biomarker analysis and detection

Bone markers
Inflammation markers
Tumor markers
Metabolic disease markers
Cardiovascular disease markers

Vaccine analysis and testing

Multiple serotype antibodies
Monovalent and multivalent vaccines

Immunogenicity testing

Screening test
Deterministic test
Titer determination