Creative Proteomics Releases Monoclonal Antibody Characterization Service for Dr

Posted by beauty33 on September 7th, 2021

Pronalyse is a new division of Creative Proteomics, which is an integrated CRO company with rich experience in providing drug development service for over 10 years. With years of experience in offering professional and high-quality products for academic use and pharmaceutical industries, Creative Proteomics Pronalyse offers monoclonal antibody characterization service.

As more and more companies join the production of monoclonal antibody drugs, monoclonal antibody drugs occupy an increasing share of the biopharmaceutical market. Monoclonal antibody (mAbs) drugs are widely used in diseases such as autoimmunity, tumors, transplant rejection, and viral infections due to their high specificity, good uniformity, high sensitivity, and mass production.

In order to ensure the safety and effectiveness of monoclonal antibody drug products, and promote orderly and benign R&D and competition in this field, relevant regulatory authorities continue to put forward new requirements for the characterization, analysis and quality control of monoclonal antibody biotherapeutics. Monoclonal antibody drugs need in-depth characterization to obtain approval for clinical trials and subsequent sales. The current quality standards of monoclonal antibody drugs mainly refer to the relevant technical guidelines of the International Human Drug Registration Coordination Conference (ICH), the Food and Drug Administration (FDA), the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP).

“Creative Proteomics provides customized solutions. We are confident to provide you with technical support related to special requirements such as drug development and production processes. At the same time, we are also equipped with many advanced technologies, such as nuclear magnetic resonance, hydrogen deuterium exchange, ion mobility mass spectrometry and other mass spectrometry, which can provide a variety of information to characterize advanced structures with key mass attributes. We also have transmission electron microscopy, X-ray diffraction and size exclusion chromatography combined with multi-angle laser light scattering to identify and characterize monoclonal antibody drug aggregates.” Said Senior Scientist of Creative Proteomics.

Creative Proteomics will provide customers with the physical and chemical structural characteristics, purity, impurities, content and other tests of monoclonal antibodies in strict accordance with various quality standards. The company can provide the following high-quality monoclonal antibody characterization services: complete monoclonal antibody analysism, analysis of peptide fingerprints and post-translational modification sites and monoclonal antibody drug glycoform analysis.

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 service to support manufacturers and researchers in biopharmaceutical development, mainly including antibodies, PEGylated proteins, peptide and protein drugs, vaccines, amino acids and their derivatives. The service provided contains in vitro characterization, purity analysis, protein structure modification, in vivo safety check, and pharmacokinetics analysis, etc.