A biosimilar (also known as follow-on biologic/subsequent entry biologic) is a biologic medical product which is a officially approved copy, or updated version of an original innovator biologic, and they can only be allowed to manufacture when the innovator product's patent expires.
Unlike the small-molecule drugs, macromolecular therapeutics generally exhibit high molecular complexity, and may be quite sensitive to changes in manufacturing, purification and storage conditions. And usually the follow-on manufacturers have no access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process. So drug regulation authorities have issued the guidance on requirements for demonstrating the similar nature of the biosimilars and innovator biologics, both in safety and efficacy.
Because of the enormous potential in medical care, a wide range of comparability programs are required for biosimilar to demonstrate similarity to the innovator macromolecule. Since tiny changes in the manufacturing of original products have shown comparable biologic products despite shifts in certain quality attributes, the biosimilars manufacturers need reliable analytical methods to establish the molecular similarity required by regulating agencies. In Creative Proteomics, our tech staff can perform a number of physicochemical and biological methods for comprehensive comparison between biosimilar and the original biologic is performed using multiple analytical methods, based on the following (but not limited to):
1. Reverse Phase-HPLC,Size Exclusion Chromatography, Ion Exchange Chromatography;
2. 2-aminoanthranilic acid derivation & Normal Phase HPLC;
3. Capillary Electrophoresis-SDS & Capillary isoelectric focusing;
4. Intact mass analysis by LC-MS;
5. Peptide mapping with LC-MS/MS
Both the primary and higher-order protein structures would be compared utilizing the characteristic approaches. The tech staff are glad to discuss the details of the experiments and your special requirements, to provide a customized, optimized analytical support to your comparative characterization of the biosimilar and innovator.