Objective To investigate the impact of annealing on the lyophilization process and the pharmacological activity of biological products.Methods According to the annealing temperature that obtained from Differential Scanning Calorimetry(DSC)method,the lyophilization process that with and without annealing during freezing were compared,and used the protein products after the determined annealing process for pharmacological activity testing.Results With annealing,the percentage of cracked lyophilized products decreased significantly and the lamination was almost disappeared,the pharmacological activity of protein products produced by annealing process met the requirements.Conclusion In the process of biological products lyophilization,annealing can yield a good drug product cake appearance without the cracks and lamination.Besides,annealing can also decrease the residual moisture of the product and increase the collapse temperature,so that can increase the efficiency of lyophilization,and did not affect the pharmacological activity of protein products.
维普
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