Implementation of CQA (Critical Quality Attribute) Based Approach for Development of Biosimilars

Critical quality attributes (CQAs) of the product is one of the major factors that needs to be considered while developing and selecting the potential biosimilar candidates (clones/cell lines). In order to develop potential biosimilar molecules, we should implement CQA approach from transfection to final clone selection, process optimization to formulation development, and commercialization. The CQA-based product development approach allows the biopharmaceutical industries to develop the recombinant biosimilars with the highest quality and efficacy standards and a cost advantage that can be transferred back to the large population. This chapter provides a brief overview on a CQA-based approach for a successful recombinant biosimilar development. It summarizes the CQAs of the recombinant products at each stage of the product development cycle, and the advantages of identification and implementation of the CQA approach from clone to clinic in developing a high-quality and efficacious biosimilar product.