Pronalyse, a new division of Creative Proteomics, is an integrated CRO company with rich experience in providing drug development services for over 10 years. Creative Proteomics Pronalyse recently announced the launch of antibody-drug conjugates (ADCs) characterization service to ensure the safety and effectiveness of ADCs drugs.
In recent years, there has been a global upsurge in the research and development of antibody-drug conjugates (ADCs). ADCs are novel therapeutic biotechnology drugs that are conjugated with monoclonal antibodies and small-molecule drugs with strong cytotoxicity through biologically active linkers. It is a potent anticancer drug that targets cancer cells at a specific site, and is considered to be an important means of disease treatment in the future.
“Compared with monoclonal antibodies, ADC has a complex structure and a high degree of heterogeneity, which brings great challenges to its structural characterization and characteristic analysis. Among them, the determination of the poison-antibody coupling ratio (DAR), the analysis of the poison-conjugation site and the coupling ratio of the site are quite complicated and difficult. Creative Proteomics Pronalyse’s bioinformatics platform will help you solve these problems and challenges,” said the Senior Scientist of Creative Proteomics.
The mechanism of drug action is to specifically target cancer cells through monoclonal antibodies, and then kill cancer cells by coupling small molecule drugs. ADCs combine the high specificity and targeting of monoclonal antibody drugs with the high efficiency of small molecule drugs to remove cancer cells. It can synergize the advantages of antibody drugs and chemical drugs to reduce damage to biological systems.
Unconjugated naked antibodies, cytotoxic small molecules, and heterogeneity of conjugated drugs may all affect the efficacy and safety of ADC drugs. Therefore, in order to ensure the safety and efficacy of ADCs, in-depth characterization and quality monitoring of ADCs are required to obtain approval for clinical trials and subsequent marketing. The quality standards for testing mainly refer to the relevant technical guidelines (EP) of the International Conference on Harmonization of Registered Drugs for Human Use (ICH), the United States Food and Drug Administration (FDA), the United States Pharmacopoeia (USP) and the European Pharmacopoeia.
“Creative Proteomics has advanced high-performance liquid chromatography, high-throughput mass spectrometry and bioinformatics platforms. We developed a comprehensive set of methods to determine antibody-drug conjugate intact mass, deglycosylated intact mass, drug/antibody ratio, and polysaccharide composition. At the same time, we will strictly follow various quality standards and provide you with exclusive solutions,” commented the Pronalyse’s Project Manager.
About Pronalyse division of Creative Proteomics
Pronalyse is supported by specialists who are professional and skilled in protein chemistry, NMR, HPLC, mass spectrometry and bioinformatics. Currently, Pronalyse is dedicated to providing protein-oriented analysis services to support manufacturers and researchers in biopharmaceutical development, mainly including antibodies, PEGylated proteins, peptide and protein drugs, vaccines, amino acids and their derivatives. The services provided include in vitro characterization, purity analysis, protein structure modification, in vivo safety check, and pharmacokinetics analysis, etc.
Contact
Address: Shirley, NY 11967, USA
Email: [email protected]
website: https://www.creative-proteomics.com/pronalyse/antibody-drug-conjugates-adcs-characterization-service.html
