Array Bridge Inc. has developed a Protein Conformation Array (PCA) kit for three dimensional structural comparability analysis of Biologics and Biosimilars.
These PCA kits can provide valuable information on the 3-D structure and heterogeneity of biologics and can be used at many stages of biologics/biosimilars development including cell line selection, process development, formulation development and product release testing.
The kit is easy to use and in an ELISA format, and with a series of antibodies to overlapping peptides, spanning the entire length of the amino acid sequence of a Biologic, allows one to interrogate the entire surface of the biologic. The power of the system is that in its native form, few of the epitopes will be exposed on the surface of the biologic, but if the higher order structure of the biologic changes slightly, additional epitopes will be exposed, resulting in a signal increase in the well containing the antibody to that particular epitope. Effectively, the kit provides a ‘fingerprinting’ technique for the native biologic that is also primed to detect very small changes in structure due to the array of antibodies made to all the buried epitopes. It is highly sensitive to changes in structure or denaturation of the protein and is able to detect as little as 0.1% denaturation of a protein sample.
Array Bridge can perform the PCA analysis in-house from supplied samples, or can supply kits for customer use.
Source: Array Bridge