Optimization on Critical Parameters for Lyophilization of Reference Standard Viral Vaccines by Using Freeze-Drying Microscopy
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Abstract
Background: Freeze-drying or lyophilization is a process that preserves a suitable qualified for standard reference viral vaccine to control a viral vaccine quality. The exploration on real lyophilization state need the use of lots of vaccine samples and spent approximately 1-5 days a time, also it tested several times to get a suitable state.
Objective: The aim of this research was to develop a providing standard reference viral vaccine by using a freeze-drying microscopy that observed a changing of the samples while simulation, temperature, and pressure of lyophilization to verify a collapse temperature.
Methods: The study set four formulas to test the collapse temperature that under freeze drying microscopy, and took the temperature average that subsidence to calculate a primary freeze-drying temperature to set the state of lyophilization machine. Then, it trailed the real lyophilization and took these samples to test an appearance, potency, and stability.
Results: The primary drying temperatures of four formulas, that calculated, were -27.8, -28.8, -29.0, and -28.8 OC, respectively. The difference of all four formulas was not statistically significant. After taking the standards reference viral vaccines from the lyophilization to test an appearance; moisture content; reconstitution time; and percentage of potency lost (before and after lyophilization), it is found that four formulas had good characteristic and were on criteria of each testing. It excepted the test of stability at 37 OC in seven days that discovered the highest level of virus potency lost by 1.54 log PFU/0.5 ml.
Conclusion: The lyophilization method of standard reference viral vaccine by using freeze-drying microscopy was suitable for setting primary drying temperature. It was able to control temperature that was not too high until the samples collapsed and was not too low that caused using more time for lyophilization. It used the test time only 0.5-2 hours and used less samples at microliter level. Consequently, this method is suitable and able to use the country standard of freeze-drying parameter finding.
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References
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