Pronalyse is a protein characterization division of Creative Proteomics, an integrated CRO with rich experience in providing drug development services. Based on years of experience supporting the development of biosimilars, Creative Proteomics can provide comprehensive Biosimilar Analysis Solutions.
A biosimilar is a biological product that is similar to an approved biological originator, including monoclonal antibodies, recombinant proteins, blood products, etc. Biosimilar drugs are similar in quality, safety and efficacy to the approved originator drug (reference drug).
Biosimilar development is different from novel biotherapeutics or chemosimilars in that you need to introduce accurate testing analysis at all stages. “Whether it’s the determination of precise sequence, structural and quality properties of an originator or comparative head-to-head biosimilarity testing for a biosimilar to an originator, our biosimilar testing services can provide critical analysis,” stated Pronalyse’s project manager.
Creative Proteomics’s excellent biosimilar analysis solutions help laboratories meet the standards of regulatory agencies around the world. For similarities between innovative and biosimilar drug candidates, it provides sufficient analytical and biological evidence to reduce the number of clinical trials required for approval applications. Regardless of the name of these drugs (biosimilar, follow-on biologic, biosimilar, second-generation mAb, non-innovative protein, or even biosimilar drug), their goal is the same: to ensure therapeutic safety and efficacy and improve patient health.
Biosimilar analysis solutions at Creative Proteomics:
1. Characterization of protein biosimilar
Creative Proteomics helps you meet regulatory requirements through physical and chemical assays. Using advanced mass spectrometry and supporting technologies, the company determines the primary and advanced structures of glycoproteins and proteins at critical stages of development, including monoclonal antibody products, to help you meet ICH Q6B requirements.
2. Comparison of biosimilars and protein therapeutics
Creative Proteomics can provide a wide range of physicochemical and biological methods for comprehensive comparisons of biosimilars and original biologics using a variety of analytical methods such as liquid chromatography-mass spectrometry (LC-MS) for complete mass analysis, size exclusion chromatography (SEC), ion exchange chromatography (IEC), and more.
3. Different biosimilars analyses
Creative Proteomics has developed a suite of off-the-shelf assay packages to support biosimilar comparability and characterization to complete similarity studies for a range of biosimilar molecules.
“As an expert in biosimilar analysis, Creative Proteomics Pronalyse can meet all your testing requirements by providing the experience and expertise. We are also continually developing new methods to support the characterization and comparability of biosimilars. We are happy to discuss your special requirements and experimental details to provide optimized and customized analytical support for your comparative characterization of biosimilars and innovators,” he further added.
About Creative Proteomics Pronalyse
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 checks, and pharmacokinetics analysis, etc.
Contact:
Address: Shirley, NY 11967, USA
Email: contact@creative-proteomics.com