Biologicals

WHO Reference Cell Banks (RCBs)

WHO Vero RCB 10-87

The WHO Vero RCB 10-87 was established in 1987 and was subjected to a broad range of tests to establish its suitability for vaccine production. This WHO RCB provides a unique resource for the development of future biological medicines where a cell substrate with a safe and reliable history of use is desired. The WHO Vero RCB 10-87 is considered suitable for use as a cell seed for generating a Master Cell Bank (MRC).

WHO MRC-5 RCB

The WHO MRC-5 RCB was established in 2007 because of stability issues associated with the original vials of MRC-5 cells, which dated to 1966. This RCB was prepared in a qualified cleanroom environment and subjected to specified quality-control testing endorsed by the ECBS.

The principle of establishing RCBs under WHO auspices is one that offers potential solutions to future challenges for the development of vaccines and biotherapeutics in developing regions. However, WHO does not intend that cells supplied to manufacturers from any RCB be used as a MCB. The purpose of WHO RCBs is to provide well characterized cell seed material for the generation of a MCB by manufacturers with the expectation that such MCBs will comply with this guidance document and be fully characterized.

The WHO RCBs provide key advantages for vaccine development worldwide that include:

  • Traceability to origin of cells and derivation of cell line and materials used in preparation of seed stock,
  • Subjected to open international scientific scrutiny and collaborative technical investigations into the characteristics of the cells and the presence of adventitious agents,
  • Results of characterization were peer reviewed and published,
  • Investigations evaluated under auspices of WHO expert review and qualified as suitable for use in vaccine production,
  • Supply of cells free of any constraint related to intellectual property right on final products, and
  • Single source of cells with growing and scientifically and technically updated body of safety-testing data and safe history of use, giving increasing confidence for manufacturers, regulators, and public policy makers.

The Vero cell line is the most widely used continuous cell line for the production of viral vaccines over the last two decades. The WHO Vero RCB 10-87 was established in 1987 and was subjected to a broad range of tests to establish its suitability for vaccine production. This WHO RCB provides a unique resource for the development of future biological medicines where a cell substrate with a safe and reliable history of use is desired.

As concluded by an expert review in 2002, the WHO Vero RCB 10-87 is not considered suitable for direct use as MCB material. However, the WHO Vero RCB 10-87 is considered suitable for use as a cell seed for generating a MCB, and its status has changed from "WHO Vero cell bank 10-87" to "WHO Vero reference cell bank 10-87".

The WHO Vero RCB 10-87 is stored in the:

  • European Collection of Animal Cell Cultures (ECACC), Salisbury, Wiltshire, UK
  • The American Type Culture Collection (ATCC), Manassas, Virginia, USA.

These public service culture collections have distributed ampoules under agreements with the WHO to numerous manufacturers and other users. The WHO Vero RCB 10-87 is the property of WHO, and there are no constraints relating to intellectual property rights. The WHO Vero RCB 10-87 is available free of charge on application to WHO. However, due to the limited number of vials remaining, distribution of these vials is restricted solely for the production of vaccines and other biologicals. Potential replacement of the WHO Vero RCB 10-87 is currently under consideration.

WHO also has overseen the establishment of seed stocks of MRC-5 for the production of vaccines. The WHO MRC-5 RCB was established in 2007 because of stability issues associated with the original vials of MRC-5 cells, which dated to 1966. This RCB was prepared in a qualified cleanroom environment and subjected to specified quality-control testing endorsed by the ECBS.

Conditions for obtaining WHO Vero reference cell bank 10-87 at the following site:

WHO Release Conditions Form:

The WHO MRC 5 RCB is stored in the:

  • The National Institute for Biological Standards and Control (NIBSC), Potters Bar, UK

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Last update:

9 October 2013 16:53 CEST