Biologic comparability is essential to the successful development of biosimilars; the 3-D conformation of a protein is an important factor in its biological function. Due to their large size and rotational characteristic, proteins generally exhibit complex 3-D conformations.
We are one of the few supplier in the market offering a wide range of 3D Conformational ELISA kits which provide a sensitive, systematic, and robust measurement of biosimilar conformation comparability at the molecular level. This assay can be used at every stage of biosimilar development, from cell line selection to product release.
The assay uses more than 30 polyclonal antibodies to cover an entire mAb, thereby measuring its surface –epitope distribution systematically and sensitively, providing a unique measurement of biosimilar mAb HOS Comparability.