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What is Characterization of Biologics?

What is Characterization of Biologics?

Characterization of biologics plays an important role in the development of Biopharmaceuticals, such as monoclonal antibodies, fusion proteins, antibody drug conjugates, biosimilars etc. Characterization is the analysis of biologics to understand the primary, secondary, tertiary, and other higher order structure using physicochemical, biophysical and biological methods. During biologics drug development process, physicochemical, biophysical and biological properties can have an impact on the product's performance and safety.

Why characterize Biologics?

According to ICH Q6B guidelines, biologics characterization is the essential part of the successful development of bio-pharmaceuticals. In-depth knowledge of biologics and their chemistry, structure, and biological activities facilitates smoother process design to ensure the drug to attain critical product safety, purity, and potency.

Characterization and analysis of Biologics and Biosimilars requires highly sophisticated analytical workflows with significant emphasis on GMP and regulatory compliance. Development of both originator biotherapy and biosimilar products requires thorough characterization to ensure robust and well specified biological drug. Characterization of biologics includes identity testing, analysis of post translational modifications (PTM), physical testing, size distribution, analysis, sterility testing, impurities, etc.

Comprehensive support from discovery research into commercialization


Our capabilities

Our laboratories are well equipped with broad analytical technologies and our expertise in high end mass spectrometry (Orbitrap and QToF) analysis allows us the ability to provide High-Resolution Accurate-Mass (HRAM) data, that meets cGLP, cGMP and regulatory requirements.

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bd_global@crystalpharmatech.com +1-609-604-8303
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
Suite B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park, Suzhou, China, 215123
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
bd_global@crystalpharmatech.com +1-609-604-8303