Complex Protein Synthesis and Folding

Biosimilars are not simple chemical compounds but large, structurally complex proteins that require precise synthesis within living cells. Once the genetic instructions are introduced into engineered host cells, these cells produce the target protein through tightly regulated biosynthetic pathways. Proper protein folding is essential to ensure the correct three-dimensional structure, which directly influences the biologic’s function, stability, and immunogenicity. Inaccuracies in folding or modifications can lead to loss of activity or safety concerns. Therefore, maintaining fidelity in protein synthesis and folding is critical in achieving biosimilarity to the reference product.