Optimization of a freeze-drying cycle of a viral vaccine based on changes in temperature, time and geometry of the vials.
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Date
2015-09
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Abstract
The freeze-drying process is used in pharmaceutical industry, however in terms of process management, the
process must be avoided at all cost because it has several disadvantages such as high 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 freeze-drying cycle time of a viral product and
consider loading this product at subzero temperatures to increase productivity of this product. Experiments were
carried out with freeze-drying cycles with less 15 and 20h in comparison to the original cycle. The experiments
were performed with the same formulation of the commercial batch and using a pilot freeze dryer. Modifications
were made in the physical properties of the current freeze-drying cycle (temperature, pressure and time) and the
loading temperature of the product, without changing the formulation of the vaccine or primary loading. Samples
of the lyophilized product trial were analyzed for their appearance, performance, residual moisture, strength and
accelerated thermostability in the amount currently used by the company quality control. All the results were
within the specifications of the company were close to or better when compared to commercial batches.
Description
Keywords
Freeze-Drying, Viral Vaccine, Vaccine productivity, Lyophilization, Optimization
Citation
Neves Alexander da Silva, Luna Aderval Severino, da Costa Antonio Carlos Augusto. Optimization of a freeze-drying cycle of a viral vaccine based on changes in temperature, time and geometry of the vials. Journal of Applied Pharmaceutical Science. 2015 Sept; 5(suppl_2): s22-s29.