Are you looking to conduct analysis and characterization of your biosimilars?
What are biosimilars ?
Biosimilars are biological products that are highly similar to already authorized biological medicines, known as reference material. They are produced from living organisms and are used to treat various diseases, including cancers, autoimmune diseases, and inflammatory disorders.
Why characterize biosimilars in the laboratory ?
Analyzing and characterizing biosimilars in a laboratory is essential to ensure that these medicines offer the same efficacy, safety, and quality as the reference biological medicines, always following guidelines such as ICH Q6B. Although they are not exact copies due to the complexity of their production, biosimilars must demonstrate equivalent efficacy, safety, and quality to their reference medicines. This process includes comprehensive comparative studies, such as physicochemical analyses, biological tests, and clinical trials. These analyses assess the structure, function, purity, and stability of the biosimilar in comparison to the original medicine.
Our solutions to meet your biosimilar analysis and characterization needs
Why choose FILAB ?
FILAB, a laboratory specialized in analytical expertise, offers in-depth expertise in the analysis and characterization of biosimilars, in compliance with current guidelines, particularly ICH Q6B. With this expertise, we design analyses tailored to your specific needs at each stage of development, especially for comparing your biosimilar to the reference product.
Our laboratory’s analytical services can be customized to meet your needs throughout the development and production cycle, with particular attention to the critical quality attributes (CQAs) of your biosimilars.
Our analysis services
Structural analysis and characterization of biosimilars
Reduced forms (HC, LC, Fab, FC)
Glycosylation profiling
De novo sequencing
Physicochemical characterization
Our laboratory provides precise data on the size, mass, and physicochemical properties of biosimilars, essential for their development, validation, and quality control :
Impurity identification in biopharmaceutical products
The detection, analysis, and characterization of impurities are crucial to ensuring the safety, efficacy, and regulatory compliance of biosimilars:
For process-related impurities, our laboratory offers specific tests, such as the quantification of elemental impurities according to USP 233 and ICH Q3D, as well as extractables and leachables (E&L) analyses. We also analyze cell culture media (amino acids, vitamins, saccharides) to ensure the quality of biosimilar bioproduction processes.
