Biomedical Engineering Reference
In-Depth Information
donation, procurement, testing, processing, preservation, storage
and distribution of human tissues and cells (Heinonen et al., 2005).
Individual member states are responsible for implementing legislation
that reflects the directives (Hoeyer, 2010).
In the UK, the Human Tissue Authority was established to issue
licences for therapeutic products in line with the EU directives
(Daniels et al., 2006). Along with the rules governing safety and
quality in Directive 2004/23/EC and the other rules mentioned
above, Directive 2003/94/EC states that all human therapeutic
tissues should be produced using GMP (Daniels et al., 2006). Factors
that have been identified as important for producing clinical-grade
products in the UK have included the development of
GMP-compliant clean rooms, the training of management personnel
and the quality management processes adopted in production
(Daniels et al., 2006). Notably, in the UK, the use of reagents and
other starting materials that are not certified as clinical grade by the
supplier also pose problems for the development of GMP-compliant
therapeutic tissue products (Daniels et al., 2006).
At this stage, globally most cell production facilities are developed
independently of others. The range of guidelines at the national and
international level that influence the development of cell production
facilities will have a big impact on the progress to clinical treatment
opportunities. Requirements for certification of clinical-grade
products, like in the EU, could potentially force companies to
produce GMP compliance documentation for the cell lines that they
sell, adding cost and complexity to the production process. Over
time, however, it might be expected that greater harmonization
between production locations will become more important as
products start to move to clinical testing. Harmonization has been
a well-documented phenomenon in hESC research, so it might
reasonably be expected to occur in adult and iPSC research too.
6.2.2 Stemcellbanking
Stem cell banking is another possibility for commercial development
around iPSC research. A number of iPSC banking initiatives are
