RESEARCH ON ESTABLISHING AND EVALUATING THE QUALITY OF CELL RK13 USED IN TESTING VACCINES AND BIOLOGICAL
DOI:
https://doi.org/10.56086/jcvb.v2i2.34Keywords:
Bank of cell line RK13, MCB, WCBAbstract
Background/Purpose: Research on the development of the Master Cell Bank (MCB) and
Working Cell Bank (WCB) and evaluated the quality of the bank RK13 cell line from the
RK13 International Reference cell line (ATCCRCCL-37TM).
Methods: Empirical description research invitro
Results: Research results have established the MCB banks include (252 tubes encoded
NICVB/MCB01-21 with a concentration of 2.25 x 106/tube) and the WCB bank includes
(356 tubes encoded NICVB/WCB01-21 with a concentration of 1.67 x 106/tube) which meets
the quality of specifications as requirement criteria Sterility; Mycoplasma; homogeneity; no
foreign agents contamination; and viability according to the WHO’s standards.
Conclusion: From the research results, it is possible to use the RK13 MCB and WCB cell
banks in the quality control of vaccines and medical-biological products at NICVB and
manufacturers’ testing laboratories