1.Quality control of recombinant oncolytic adenovirus/p53.
Kai GAO ; Hua BI ; Youxue DING ; Yonghong LI ; Chunmei HAN ; Ying GUO ; Chunming RAO
Acta Pharmaceutica Sinica 2011;46(12):1476-82
To establish a detection method of oncolytic adenovirus/p53 and standard of quality control, human telomerase reverse transcriptase (hTERT) promoter, CMV fusion promoter containing hypoxia reaction element (HRE) and p53 gene were identified by vector DNA restriction enzyme digestion and PCR analysis. The result conformed that all modified regions were in consistent with theoretical ones. Particle number was 2.0 x 10(11) mL(-1) determined by UV (A260). Infectious titer was 5.0 x 10(10) IU mL(-1) analyzed by TCID50. In vitro p53 gene expression in human lung cancer cell H1299 was determined by ELISA, and A450 ratio of nucleoprotein in virus infection group to control group was 5.2. Antitumor potency was evaluated by cytotoxicity assay using human lung cancer cell A549, and the MOI(IC50) of this gene therapy preparation was 1.0. The tumor cells targeted replication ability of recombinant virus was determined by TCID50 titer ratio of filial generation virus between human lung cancer cell A549 and human diploid epidermal fibrolast BJ cells after infected by virus with same MOI. TCID50 titer ratio of tumor cell infection group to normal cell infection control group was 398. The IE-HPLC purity of virus was 99.5%. There was less than 1 copy of wild type adenovirus within 1 x 10(7) VP recombinant virus. Other quality control items were complied with corresponding requirements in the guidance for human somatic cell therapy and gene therapy and Chinese pharmacopeia volume III. The detection method of oncolytic adenovirus/p53 was successfully established for quality control standard. The study also provided reference for quality control of other oncolytic viral vector products.
2.Practice and Exploration on Building a Financial Supervision System to Promote High-Quality Development of Public Hospitals
Yujiao YANG ; Chunmei BI ; Tao XU
Chinese Health Economics 2023;42(12):104-107
Public hospitals are the mainstay of China's healthcare service system and play a crucial role in promoting the construction of a Healthy China.A scientific financial and accounting supervision system can effectively ensure the realization of the financial and accounting supervision objectives of public hospitals.Through the construction of the"1455"framework,it determines the goals and requirements for financial supervision,clarifies the functions,scope,and path of financial supervision.Taking China-Japan Friendship Hospital as an example,it summarizes the innovative practices and achievements in improving systems,strengthening budget management,and promoting digitalization,based on the five major systems and five functions of the supporting framework.It provides practical experience for the establishment and improvement of the financial supervision system in public hospitals,promotes the realization of the goals of financial supervision in the healthcare industry,and advances the modernization of the healthcare governance system and governance capabilities.