Manufacturing and Formulation Development of Lyophilized Crude Taq DNA Polymerase Extract

Finding the optimal formulation for the lyophilization of biomolecules, such as antibodies and other proteins, is an essential component in drug development to preserve the drug product and increase its shelf life. In this study, we developed a lyophilization formulation for crude Taq polymerase, a common DNA polymerase enzyme used to amplify DNA through the Polymerase Chain Reaction (PCR) technique. Lyophilization is a standard process to stabilize and preserve biomolecules such as antibodies, enzymes, peptides, and small molecules. Through a formulation screen, we identified optimal lyophilization (lyo) formulations that resulted in a lyo cake with good physical characteristics while maintaining polymerase activity upon reconstitution. Subsequently, we found that our lyo formulation preserved the polymerase activity even after the Taq crude extract was stored at elevated temperatures for weeks.