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

Contact Us:

Email : marketing@medicilon.com

Tel : +44 1223 981 792（Europe）

+82 (0)70-8269-5849（South Korea）

08044216898（Japan）

+86 021 58591500（China )

Website: https://www.medicilon.com

What is Bioanalysis

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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