Medicilon Biotechnology Pharmaceutical Bioanalysis Service Platform

Biotechnology drugs are known as one of the most promising areas 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. The Pharmaceutical Bioanalysis Department of Medicilon Biotechnology can provide domestic and foreign customers with better quality, greater throughput and higher efficiency biological analysis services.

Medicilon’s drug bioanalysis service team is composed of nearly 20 experienced technicians. Compared with the past, the equipment not only meets multiple configurations in quantity, but also adds a lot of new instruments, such as immunogenicity analysis. The gold standard instrument-the 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 help of the verified laboratory information management system (Watson LIMS 7.2), which can provide customers with global quality service.

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 achieved remarkable results in the treatment and prevention of diseases, which have attracted the attention of governments of all countries. Since the first monoclonal antibody drug entered the market in 1986, more and more pharmaceutical companies have carried out biotechnology drug research and development. Among them, bioanalysis is an important link in the early stage of research and development, which is used to evaluate and explain pharmacokinetics and toxicology. The scientific basis for research on kinetics, 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 Pharmaceutical Bioanalysis Department of Medicilon Biotechnology provides professional technical services that fully comply 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.

Part of biotechnology drug bioanalysis equipment:

Services available for bioanalysis of biotechnology drugs

(Mainly applicable to antibodies, ADCs, vaccines, proteins, etc.):

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, toxicity 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

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