Study On The Quality Of Recombinant Trivalent Human Papillomavirus Vaccine Protein

Cervical cancer as the most common malignant tumor of modern women,seriously affected the health of women.In recent years,more and more cases of cervical cancer have been reported in China;morbidity and mortality rates also showed a rising trend year by year.At present,there is yet no effective treatment of cervical cancer worldwide.The development of preventive cervical cancer vaccine is the only effective means to prevent the occurrence of the disease.The main types of HPV virus infection in women with cervical cancer in China are HPV16,18 and 58.Our company has developed a vaccine based on the surface proteins of these HPV types.Through strict quality control to ensure the safety and effectiveness of the vaccine is the primary premise and protection of vaccine production and application.This study is to develop comprehensive and reasonable quality standard research projects and methods based on the relevant contents of the"Chinese Pharmacopoeia"(2015 edition)combining the production process and characteristics of this product.The results are as follows:(1)Preparation of the physiochemical reference substance of the protein bulk.The protein of physiochemical reference substance was characterized by mass spectrometry molecular weight determination,isoelectric point analysis,amino acid composition analysis,C-terminal amino acid determination,peptide fingerprinting-peptide sequence coverage analysis,and VLP electron microscopy observation.The results of these analyses confirmed that the structures of the HPV16,18 and 58 VLP proteins in the protein bulk are consistent with the theoretical design.(2)The establishment of test methods for the target protein.These mainly include protein content,purity,peptide map,antigen relative potency,GST tag residuals,recombinant GST-3C fusion protease residuals.(3)Testing of the produced protein bulks to ensure the safety and effectiveness of the vaccine.The tests included protein content,purity,peptide map,VLP average particle size,N-terminal amino acid sequencing,antigen relative potency,GST tag residual,recombinant GST-3C fusion.protease residual.The results showed that the vaccine is safe and effective.