Formulation Factors

Biologic drugs are highly complex molecules produced by living cells/organisms through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications or during the manufacturing process. The extent of the variation in each of the CQAs contributes to the quality of the biologic products. To this end, preventing deviation from the required specifications over time and avoiding the various implications is of paramount importance.

Formulation factors presented herein include adjuvants used for the injectable solution, manufacturing condition (e.g., freeze-dry cycle) and impurities. Impurities could be attributed to the host organ or cell components, resin residues for purification or container plasticizer. All the above-mentioned formulation components contribute individually or collectively to the stability, immunogenicity and thus efficacy and safety of the biologic products.