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Pronalyse Division Supports Biopharma Research with Protein Homogeneity Analysis Service

Pronalyse, a new division of Creative Proteomics, is dedicated to providing professional analysis services in biopharmaceutical development. Creative Proteomics is an integrated CRO company with more than 10 years of experience in providing impurity analysis and analytical characterization service for bioprocess development. Recently, the product manager of Pronalyse division announced protein homogeneity analysis service to speed up the drug development process.


In the past 20 years, the biopharmaceutical industry has made great strides. These biological drugs specifically include amino acids and their derivatives, peptides, monoclonal antibodies, recombinant proteins, vaccines, oligonucleotides, etc. Before clinical research, the biological activity or potency of biomolecules must be defined to ensure their drug efficacy. However, the complexity of biopharmaceuticals often poses challenges for evaluating structure, heterogeneity, aggregation, physical and chemical properties, stability, and impurities.


Antibodies, protein-based therapeutics and other recombinant proteins are the final products in the biotechnology and pharmaceutical industries, and their purity and heterogeneity must be determined. Contaminants and modified forms in the product during the production process will greatly change the biological activity of these proteins. The contaminants and modified forms in the product should be removed to ensure high purity and then the safety and effectiveness of protein drugs. In order to successfully evaluate each step of the production system, it is important to develop sensitive and accurate analytical methods for protein purity and homogeneity.


Protein drug impurities can be divided into two types: modified forms or products and contaminants from the host, culture media, and separation processes (such as affinity chromatography). The purity and homogeneity of the protein are usually determined by SDS-PAGE, which can separate proteins according to their different sizes. Isoelectric focusing IEF is a more sensitive method for protein purity and homogeneity detection based on charge differences. HPLC is a simple and rapid method for purity and homogeneity analysis without any special sample pretreatment.


Creative Proteomics follows the ICH Q6B guidelines on biotechnological and biological products requirements, and analyzes the principles of identity, purity, quantity, and safety and effectiveness related to products and processes. With rich experience and capabilities in biopharmaceutical research, Creative Proteomics provides comprehensive biopharmaceutical analysis services tailored to the research, manufacturing and clinical application of protein biotherapies.


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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.




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Last Updated: 24-Feb-2021