Publication number |
CLPUB00784 |
Authors |
Hawkins J.R., Stylianou M. |
Title |
Second replacement seed stock for MRC-5 cells. Proposal for WHO reference cell bank status. |
Citation |
(In technical document) World Health Organization publication WHO/BS/2018.2347; pp.1-7; WHO; Geneva; Switzerland (2018) |
Web pages |
https://www.who.int/publications/m/item/WHO-BS-2018.2347 |
Abstract |
The original seed stock of MRC-5 cells ("PDL7") was established in the
1960s at the laboratories later known as the National Institute for
Biological Standards and Control in the UK. These original stocks have
been released by NIBSC for the development of vaccines over several
decades. MRC-5 cells are a human diploid fibroblast culture which can be
passaged in vitro for approximately 60 population doublings, when they
become senescent and cease to replicate i.e. they are a 'finite cell line'.
The need to supply new vaccine manufacturers, particularly in the far east
and the need to periodically replace stocks at manufacturers who
previously received MRC-5 cells has meant that NIBSC stocks of these cells
have become depleted. This fact, combined with an observed deterioration
of the original glass vials in which the cells were originally frozen
resulted in the need to replace the stocks supplied to manufacturers to
ensure continuity of supply of these cells for vaccine development. A
proposal for a replacement stock was submitted to the ECBS in 2006 and
approved. The resulting replacement PDL12 bank (bank number: 660902-M01)
was endorsed by the ECBS in 2007. Due to concerns about inadequate cell
numbers per vial and the veracity of the population doubling level, the
'M01' bank has now been replaced with a new seed bank at a PDL13 (660902-M02).
This second replacement MRC-5 seed bank consists of 189 vials at ~4.3 x 10^6
cells/vial at PDL13 (bank number: 660902-M02) and is proposed for endorsement
by ECBS as a WHO Reference Cell Bank.
|
Cell lines |
CVCL_JF54; MRC-5 PDL12 |