Regeneron Pharmaceuticals, Inc.

Regeneran Pharmaceuticals, Inc.

Franco Tzul

Ravi Chari

Xiaolin Tang

Mary Kleppe

Dingjiang Liu

Bowen Jiang

Lyophilization methods for preparing protein formulations for long-term storage at room temperature or improved stability at refrigeration storage are provided. Specifically, the present application provides lyophilization methods to obtain a target percentage of residual moisture of a lyophilized product, such as 3-5% residual moisture. The secondary drying of the lyophilization can be conducted under controlling rate of desorption under a temperature which is similar to the shelf temperature of the primary drying. Alternatively, the lyophilization can be conducted without a distinguished secondary drying step.

Target residual moisture content for lyophilized drug product

Methods and systems for identifying capsid viral proteins in a sample containing viral vectors are provided, including determining the ratio of the capsid viral proteins of adeno-associated virus. The methods and systems comprise denaturing the capsid viral proteins in the sample, labelling the denatured capsid viral proteins with a lysine-conjugation dye, generating a separation profile of the denatured/labelled capsid viral proteins using microchip capillary electrophoresis, quantifying levels of the capsid viral proteins based on the separation profile, determining a quantification ratio of the capsid viral proteins based on the separation profile, and normalizing the quantification ratio based on lysine contents of the capsid viral proteins.

Characterization of adeno-associated virus using microchip capillary electrophoresis

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Hartsdale, NY, United States of America

Franco Tzul