Application of Quality by Design in a Commercialized Lyophilized Vaccine
AbstractThe pharmaceutical industry has being implementing regulatory practices to assure that consumers obtain products with quality, safety, and efficacy. The use of Quality by Design (QbD) for products on development has increased though the years to avoid issues related to quality parameters and has been suggested by Regulatory Agencies to standardize globally the documentation for the registration of new products. Although the concepts of QbD gain importance, it is still not a widespread practice to existing systems and products already on the market. This work aims to propose a case study with a vaccine using QbD concepts on the lyophilization unit operation production step to provide robustness and increase efficiency, leading to a lyophilization cycle time reduction. To this end, a reverse way of the use of QbD principles were applied based on historical batches database, down scale experiments, and finally in industrial scale to establish new boundaries in the lyophilization cycle. Experimental batches samples were analyzed through accelerated and real time stability study. At the end, this case became a possibility to establish new ranges to lyophilization process predicting risks and assure robustness to this production step with the maintenance of quality and safety of vaccine.
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