兽医科技

Individual and Multiplex PCR Assays for the Detection of Adventitious Bovine and Porcine Viral Genome Contaminants in the Commercial Vaccines and Animal Derived Raw Materials

Abstract

Maroudam Veerasami, Chitra K, Mohana Subramanian B, Thamaraikannan P, Srinivasan VA, Dhinakar Raj G

Animal derived raw materials such as trypsin and Fetal Bovine Serum are used in vaccine manufacturing and pose the threat of introducing animal pathogens as contaminants into the final products. Thus screening for adventitious virus/ genome is part of quality control in manufacturing of biologicals. Various in-vitro and in-vivo detection assays have been developed for the detection of potential viral contaminants in vaccines. However, these assays are expensive, time consuming, labor intensive and incomplete limiting their ability to meet the increasing demands of the biological industry. Polymerase chain reaction technology scores over the in-vitro and in-vivo assays in speed, specificity, sensitivity and robustness of detection and can replace them in regular use. In the present study, a set of multiplex and individual PCRs were developed for the detection of porcine (n=6) and bovine viral genomes (n=5). Veterinary vaccines (10), human vaccines (9), porcine typsin lots (9), and fetal bovine serum (8) were screened for adventitious viral genomes using multiplex PCRs. It was observed that 60% of veterinary vaccines, 77.7% of trypsin, and 62.5% of fetal bovine serum were contaminated with adventitious viral genomes.