Biomedical Engineering Reference
In-Depth Information
global standard and continued legitimacy for stem cell research
(Crook et al., 2010). One of the functions of the UK Stem Cell Bank,
for example, is to ensure that cells are produced at the Bank using
European clinical manufacturing good practice guidelines in specially
developed facilities (Healy et al., 2005). This is in order to ensure
that once banked and expanded for potential use by researchers, the
cells do not mutate in any way and their integrity is maintained over
time (Healy et al., 2005).
However, one of the problems for the international development
of a global model of best practice for cell production in both hESC
or iPSC research is that different national regulations impact on the
regulatory requirements of different institutions. On-site processing
facilities and stem cell banks are both subject to these limitations yet
international harmonization as best practice emerges is likely in the
future. The International Stem Cell Banking Initiative is also working
to establish criteria that might both meet national regulatory
standards yet also provide for the emergence of consensus practices
internationally in order to facilitate greater access to stem cells for
the research community (Healy et al., 2008).
A key concern with stem cell banking, however, is how it will
impact on the commercial development of the stem cell sciences
(Courtney et al., 2011). With private biobanking, like the
cord-blood banks, the commercial aspect lies in the sale of banking
services and the payment of fees by individual storers. Public
biobanks, by contrast, are set up as repositories and distributors of
important materials, like blood or other tissues. The UK Stem Cell
Bank (UKSCB) is a public biobank that was established for this
reason, namely to act as the custodian and guardian of precious
hESCs. The UKSCB is thus integrated into regulations governing the
conduct of hESC research in the UK and has multiple levels of
governance monitoring it (Stephens et al., 2008). However, some
commentators have observed that the principle of fair distribution to
researchers that is central to the UKSCB will impact on the incentive
for companies to develop products for the market (Courtney et al.,
2011). The high cost of development, combined with the lack of
capacity to restrict uses of publicly banked stem cell lines, is argued
to provide a disincentive for commercial development if exclusive
