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 can provide comprehensive biosimilar analysis solutions.
Biosimilar drugs have the same active ingredients as the original drugs, and there is no significant difference between the two in terms of dosage, dosage form, route of administration, safety and effectiveness, quality, therapeutic effects and indications. It has important economic and social benefits such as reducing medical expenditures, improving the availability of medicines, and improving the level of medical services.
Biosimilars can be produced when the patent of the original drug expires. However, due to the high molecular complexity of biosimilars, they may be more sensitive to small changes in the manufacturing process. Before conducting animal and clinical trials, it is necessary to characterize biosimilars in accordance with the guidance document ICH Q6B, which provides a unified set of internationally recognized specifications for the identification of biological and biotechnological products.
“Biosimilars will bring hope of survival to more patients suffering from major diseases. As experts in the field of biosimilars, we are well aware that it requires extremely complex processes to make biosimilars and reference preparations highly similar. We provide comprehensive testing and development services, from biosimilar cell line development, existing and custom analysis, to biosafety testing and cell bank manufacturing. We have unparalleled expertise and are your ideal supplier for complete solutions.” Said Senior Scientist of Creative Proteomics.
Based on years of experience to support the development of biosimilars, Creative Proteomics can provide comprehensive biosimilar analysis solutions including characterization of protein biosimilar, comparison of biosimilars and protein therapeutic, and different biosimilars analyses.
“At Creative Proteomics, we have many years of experience in researching a range of biosimilar molecules and integrated services that support the development of biosimilars. We also continue to develop new methods to support the characterization and comparability of biosimilars. We are happy to discuss your special requirements and experimental details in order to provide you with optimized and customized analysis support for the comparative characterization of biosimilars and innovative drugs.” Commented the Marketing Manager of Creative Proteomics.
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.