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Lyophilization process design and development of human plasma derived Alpha 1 proteinase inhibitor
Sumita Bardhan1, Dhruv Parikh1, Sheetal Dolia1
1Intas Pharmaceuticals Ltd. (Plasma Fractionation Centre), Ahmedabad, India.
None:
Lyophilization is the preferred method to stabilize labile protein formulations in order to attain longer shelf life. Thus, the understanding of different parameters of lyophilization along with inherent properties of plasma protein formulations is very essential to achieve improved stability.
Objective:
The present study aims to optimize the lyophilization cycle of one of the plasma proteins, Alpha-1 proteinase inhibitor (A1PI) to obtain a homogeneous and consistent cake structure using different lyophilization cycle parameters: slow freezing, fast freezing, and fast freezing with annealing.
Methods:
Process analytical technology (PAT) tools like product probe temperature, Lyo Rx, LyoLogplus software were implemented for continuous lyophilization cycle monitoring, determination of freezing and eutectic points. Formulation parameters like fill volume and solid content were screened to study the impact on the product quality. Fast freezing with annealing demonstrated homogenized cake appearance, similar size crystals with more number of pores, optimum reconstitution time as well as moisture content. High fill volume proved to be beneficial for obtaining a homogenized cake structure.
Results:
The product quality attributes demonstrated similarity with the market comparator. Desired quality attributes of A1PI freeze dried cake were achieved by optimizing lyophilization cycle parameters along with formulation parameters.
Conclusion:
The understanding of different concepts of lyophilization can be utilized for the optimization of lyophilization parameters of other plasma proteins.
