Otimização do ciclo de liofilização de uma vacina viral

Abstract

Lyophilization or Freezing drying is a complex multistage process - where the product is first frozen and dried by sublimation. Do to this process, the lyophilization becames an attractive process particularly important to stabilizing hydrated and labile organic compounds of biological origins. The lyophilization process is widely used in pharmaceutical industry, however in terms of process management, the process must be avoided at all cost This process has several disadvantages, such as costly equipment investment, high energy demand, a process that requires long times and products easily to moisturize and fragile and needs to be carefully packed and stored. This work aims at reducing the lyophilization cycle time of a viral vaccine and consider loading this product at subzero temperatures in order increase productivity. To this end, experiments were carried out with lyophilization cycles with 17 and 20h unless the original cycle of commercial vaccine. The experiments were performed with the same formulation of the commercial batch and using a pilot freeze dryer. The modifications were made in the physical properties of the current lyophilization cycle (temperature, pressure and time) and the load temperature of the product, without changing the formulation of the vaccine or original packing. Samples of the lyophilized product trial were analyzed for their appearance, performance, residual moisture, strength and accelerated thermostability and compared due to Minimum Requirements of Health Word Organization. All the analyzed results were within the specifications and the results were close to or better when compared to commercial batches of origin