Study on the Quality of Lyophilized Human Diploid Cell Rabies Vaccine Using Microcarrier Technology

Abstract

The aim is to study the potency, purity, safety, and stability of the lyophilized human diploid cell rabies vaccine (HDCV). The viruses were harvested from infected human diploid cells (MRC-5 strain) which were cultured in a microcarrier bioreactor. After harvest, purification, inactivation and lyophilization, HDCV was produced. The potency of vaccines was measured by NIH method; the bovine serum protein residual content and the antibiotic residues were tested by ELISA method; the endotoxin content was detected by semi quantitative gel method; the safety of vaccine was determined in vivo. Among 6 batches of HDCV, the lowest immunizing potency was 4.79 IU/ml, whilst the highest was 6.03 IU/ml; the lowest bovine serum protein residual content was 12.41 ng/dose, whilst the highest was 31.74 ng/Dose; the content of antibiotic residues was from 2.20 ng/ml to 4.00 ng/ml; endotoxin levels were all lower than 50 EU/dose. All the mice and guinea pigs vaccinated were all alive, and the body weight of each mouse also increased. The stability was investigated by determining the water content and potency of the vaccine placed in 37±1 °C for 4 weeks and 2-8 °C for 48 months, respectively. The results indicate all the quality index accords with the standards of “Pharmacopoeia of the People's Republic of China 2010, 3 Volumes”. HDCV shows satisfactory potency, purity, safety, and stability.