跳至主要内容

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

Related Articles:

What is Bioanalysis

评论

此博客中的热门博文

Medicilon and Binhui Biopharmaceutical Have Reached a Strategic Collaboration to Jointly Draw a New Blueprint for the Development of New Biological Drugs

  On March 18, Medicilon and Binhui Biopharmaceutical (Binui Bio) announced a strategic collaboration.  The two parties will work together to jointly explore the possibilities in cutting-edge fields such as oncolytic viruses, nucleic acid drugs and protein drugs. Gather and Work Together to Create Advantages      Facilitate the Research and Development of Oncolytic Viruses, Nucleic Acids, Proteins and Other Drugs As a one-stop biopharmaceutical comprehensive preclinical R&D service CRO, Medicilon has been developing and accumulating for 20 years, always adhering to the spirit of innovation, and has successfully constructed bi/multi-specific antibodies,  ADCs ,  mRNA vaccines ,  small nucleic acid drugs ,  PROTAC , and  CGT technical service platform  that have helped 421 INDs obtain clinical approval.  It is this outstanding achievement that has earned Medicilon wide recognition in the industry and laid a solid foundation f...

A Nickel-Catalyzed Reductive Alkylation of Aryl Bromides and Chlorides for Sp3-Sp2 Bond Formation

  In 2012, a nickel-catalyzed reductive alkylation method of aryl bromides and chlorides was reported. Under the optimized conditions, a variety of aryl and vinyl bromides as well as active aryl chloride can be reductively coupled with alkyl bromides in high yields. The protocols were highly functional-group tolerant and the reactions were not air or moisture sensitive. The reaction showed different chemoselectivity than conventional cross-coupling reactions. Substrates bearing both anelectrophilic and nucleophilic carbon resulted in selective coupling at the electrophilic carbon (R-X) and no reaction occurred at the nucleophilic carbon (R-[M]). The 2010 Nobel Prize in Chemistry was awarded for the Pd-catalyzed cross-coupling, and in the past decade the progress in cross-coupling has not only had a significant impact on academic research but has also influenced the industrial synthetic application. The transition-metal-catalyzed union of nucleophilic organo-boronic acids with elect...

What is Toxicokinetics?

Toxicokinetics  is essentially the study of “how a substance gets into the body and what happens to it in the body”. Four processes are involved in toxicokinetics. The study of the kinetics (movement) of chemicals was originally conducted with pharmaceuticals and thus the term pharmacokinetics became commonly used. In addition, toxicology studies were initially conducted with drugs. However, the science of toxicology has evolved to include environmental and occupational chemicals as well as drugs. Toxicokinetics is thus the appropriate term for the study of the kinetics of all toxic substances. Frequently the terms  toxicokinetics ,  pharmacokinetics , or disposition may be found in the literature to have the same meaning. Disposition is often used in place of toxicokinetics to describe the time-course of movement of chemicals through the body (that is, how does the body dispose of a xenobiotic?). The disposition of a toxicant along with its’ biological reactivi...