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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
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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.
National Institute for Control of Vaccines and Biologicals
Title: 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
Description:
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.
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