A NOVEL PRECIPITATION METHOD FOR SOLIDIFYING THERAPEUTIC MONOCLONAL ANTIBODIES: A COST-EFFECTIVE ALTERNATIVE TO LYOPHILIZATION

Therapeutic monoclonal antibodies (mAbs) have become integral in the treatment of various diseases, but their formulation and stability remain challenges for long-term storage and distribution. Traditionally, lyophilization (freeze-drying) is employed to convert mAbs into solid formulations; however, this process is time-consuming, costly, and can lead to protein instability. In contrast, a precipitation-based process offers a potential alternative for generating solid mAb formulations. This study explores the use of ammonium sulfate as a precipitating agent to solidify monoclonal antibodies while maintaining their bioactivity and stability. The process involved optimizing precipitation conditions, followed by characterizing the precipitated product using size exclusion chromatography (SEC), dynamic light scattering (DLS), and circular dichroism (CD) spectroscopy. Results demonstrated that the precipitation method achieved high yields (over 85%), with minimal aggregation and preserved structural integrity of the mAb. The solid formulation showed excellent reconstitution properties, and bioactivity assays confirmed that the mAb retained its therapeutic function. Additionally, the precipitated mAb exhibited long-term stability at room temperature, making this precipitation-based method a promising alternative to lyophilization for mAb formulation. This approach is cost-effective, scalable, and provides an efficient solution for producing stable monoclonal antibody therapies.