Abstract
In the downstream process of recombinant hepatitis B surface antigen (rHBsAg), nano-colloidal silica adsorbent (Aerosil-380) is one of the possible methods to separate the antigen from other main impurities partially. The current study aimed to maximize the adsorptive capacity of Aerosil-380 as well as rHBsAg recovery for large-scale production of recombinant hepatitis B vaccine. The experimental design methodology was used to optimize the eight critical parameters influencing the efficiency, rHBsAg recovery, of the adsorption-desorption process in the lab-scale. These examined parameters were the adsorption–desorption temperature, pH, contact time, agitation speed, antigen concentration, and desorption buffer. Under optimal condition, the maximum adsorption capacity of Aerosil-380 was equal to 3333 μg.g−1 (rHBsAg/adsorbent), and we could recover about 95% of rHBsAg with purity of 54% (rHBsAg/total protein) in the lab scale. Using the optimum parameters for rHBsAg clarification process in large-scale by Aerosil-380, we recovered about 78% of rHBsAg with 43% purity. Based on the obtained experimental data, Langmuir adsorption isotherm and pseudo-first-order kinetic model provide the best correlations of experimental data for the adsorbent. Findings of this study significantly increase the recovery of clarification process of rHBsAg in large-scale compared to previous reports.
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