EVALUATING THE QUALITY OF VERO 76 CELL BANK NATIONAL REFERENCE STANDARD USED FOR QUALITY CONTROL OF VACCINES AND BIOLOGICALS PRODUCTS USED IN TESTING VACCINES AND BIOLOGICALS PRODUCTS
The Master cell bank (Vero 76 NICVB/MCB01-18) and Working cell bank (Vero 76 NICVB/WCB01-19) are produced from international standard Vero cells ATCC 76 (ATCC CRLM- 1587TM) was studied and evaluated for quality according to the standards of the World Health Organization (WHO) including criteria such as (identification; sterility; homogeneity; viability; Mycoplasma; Retrovirus; tuberculosis bacteria; extraneous agents in vitro and in vivo). The research results show that the cell banks Vero 76 NICVB/MCB01-18 and Vero 76 NICVB/WCB01-19 meet the quality requirements according to WHO TRS 978, part 3, 2013 and WHO TRS 932 part 1, 2006 for National Reference Standard used for research and quality control of vaccines and biological products.
DOI:
https://doi.org/10.56086/jcvb.v3i3.101Từ khóa:
Vero 76 cell bank; MCB; WCB, Quality controlTóm tắt
The Master cell bank (Vero 76 NICVB/MCB01-18) and Working cell bank (Vero 76 NICVB/WCB01-19) are produced from international standard Vero cells ATCC 76 (ATCC CRLM- 1587TM) was studied and evaluated for quality according to the standards of the World Health Organization (WHO) including criteria such as (identification; sterility; homogeneity; viability; Mycoplasma; Retrovirus; tuberculosis bacteria; extraneous agents in vitro and in vivo). The research results show that the cell banks Vero 76 NICVB/MCB01-18 and Vero 76 NICVB/WCB01-19 meet the quality requirements according to WHO TRS 978, part 3, 2013 and WHO TRS 932 part 1, 2006 for National Reference Standard used for research and quality control of vaccines and biological products.
Đã Xuất bản
2023-09-21
Cách trích dẫn
Nguyen Thi Van Quynh, Pham Van Hung, Doan Huu Thien, Nguyen Hoang Tung, Trieu Thanh Hai, Nguyen Thi Mai Huong, Nguyen Khanh Ly, Pham Thi Thu Phuong, Nguyen Thu Quynh, & Le Thi Kim Thuy. (2023). EVALUATING THE QUALITY OF VERO 76 CELL BANK NATIONAL REFERENCE STANDARD USED FOR QUALITY CONTROL OF VACCINES AND BIOLOGICALS PRODUCTS USED IN TESTING VACCINES AND BIOLOGICALS PRODUCTS: The Master cell bank (Vero 76 NICVB/MCB01-18) and Working cell bank (Vero 76 NICVB/WCB01-19) are produced from international standard Vero cells ATCC 76 (ATCC CRLM- 1587TM) was studied and evaluated for quality according to the standards of the World Health Organization (WHO) including criteria such as (identification; sterility; homogeneity; viability; Mycoplasma; Retrovirus; tuberculosis bacteria; extraneous agents in vitro and in vivo). The research results show that the cell banks Vero 76 NICVB/MCB01-18 and Vero 76 NICVB/WCB01-19 meet the quality requirements according to WHO TRS 978, part 3, 2013 and WHO TRS 932 part 1, 2006 for National Reference Standard used for research and quality control of vaccines and biological products. JOURNAL OF CONTROL VACCINES AND BIOLOGICALS, 3(3), 4–17. https://doi.org/10.56086/jcvb.v3i3.101
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