The development of biosimilars poses a major challenge for manufacturers: guaranteeing efficacy, safety and quality equivalent to the reference medicine, despite the complexity of their production. To meet the strict regulatory requirements (ICH Q6B), rigorous biosimilar characterization is essential. Thanks to advanced comparative analysis, including physico-chemical and biological tests, FILAB’s laboratory specialising in biopharmaceutical analysis ensures the compliance and reliability of biosimilars, making it easier to bring them to market.
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 analysis, biological tests, and clinical trials. These analysis 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 analysis 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)
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:
Using a laboratory for your biosimilar medicines
Using a laboratory is essential to guarantee the regulatory compliance, quality and stability of biosimilars throughout their development and production cycle.
To establish biosimilarity with the reference drug at an early stage, by carrying out in-depth comparative analyses (structure, purity, biological activity).
To control batch variability and ensure that process modifications (change of cell line, culture conditions, purification) do not compromise the quality of the biosimilar.
To meet the requirements of the authorities (EMA, FDA) by providing robust data derived from validated analytical methods, including physico-chemical and biological tests.
To guarantee the conformity of batches before they are placed on the market, by carrying out stability and forced degradation studies to anticipate any variations in the product.
To ensure continuous monitoring of biosimilars by regularly comparing their analytical profile with that of the reference medicinal product and detecting any production drifts.
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) analysis. We also analyze cell culture media (amino acids, vitamins, saccharides) to ensure the quality of biosimilar bioproduction processes.
FAQ
Biosimilars must demonstrate analytical similarity to their reference drug in terms of structure, function, purity and biological activity. Regulatory agencies such as the EMA and FDA require detailed comparative analyses to guarantee their efficacy and safety.
The production of biosimilars involves complex biological systems that can lead to post-translational variations (glycosylation, aggregation, isoforms). Rigorous protein characterisation and strict control of production parameters are essential to ensure the consistency and quality of the final product.
Advanced techniques include mass spectrometry for fine analysis of molecular structure, chromatography for purity and aggregation, to validate the functional activity of the biosimilar.
Manufacturers must establish a robust comparability plan, using validated analytical methods to assess structure, stability and bioactivity. Stress and long-term stability studies help to anticipate possible differences and ensure that the biosimilar meets the safety and efficacy criteria set by the regulatory authorities.
Stability is assessed by forced degradation studies, long-term stability tests and environmental stress analyses (temperature, humidity, agitation) to ensure product integrity.
Differences in cell lines, culture media and purification conditions can induce post-translational variations (glycosylation, aggregation) which must be strictly controlled.
The authorities are asking for a robust set of physico-chemical and biological analyses demonstrating functional equivalence, as well as appropriate pharmacokinetic and clinical studies.
Our specialist laboratories use state-of-the-art instruments, validated methods and biopharmaceutical expertise to guarantee reliable results that comply with regulatory requirements.
