Biomedical Engineering Reference
In-Depth Information
Cell therapy products are increasingly regulated by guidelines
issued from regulatory bodies not only for good manufacturing, but
also quality and safety (Giordano et al., 2004). For cell products in
particular, the risks of contamination are quite high due to culturing
conditions and the length of time that cells are cultured (Giordano
et al., 2004). Thus in order to minimize contamination, dedicated
facilities, strict controls over processing methods and harmonization
of skill sets of staff through training programmes are three essential
components to manufacturing clinical-grade cell-based products
(Giordano et al., 2004). In building a clean room, attention must be
paid to entrance and exit points for personnel, the circulation and
sterilization of air, the material that surfaces are made out of, the
permeability of the space via windows and other points, potential
contaminants brought in by personnel and adequate waste disposal
processes (Giordano et al., 2004).
The three components of clean room design - dedicated facilities,
strictly controlled processing methods and harmonization of skill
sets of staff through training programmes - are also found in any
commercial factory. While the specifics of producing high-quality,
uncontaminated products vary from industry to industry, the basic
requirements are in essence the same. One aspect particular to the
cellular factory, however, is the need to validate the final product as
indeed being the product that is intended at the beginning of the
process as cells may mutate over time in culture (Giordano et al.,
2004). Accurate characterization processes are one of the more
disputed aspects of production in the stem cell sciences.
Good manufacturing protocols (GMP) for cellular products have
emerged in a number of countries around the world. GMP is a
quality assurance process traditionally used in the pharmaceutical
industry (Unger et al., 2008). It ensures that the end product is what
it is meant to be and that standard operating processes have been
observed (Unger et al., 2008). It is also meant to allow the tracing of
raw materials used in production (Unger et al., 2008). For stem cell
based products, GMP would also have to include the isolation,
freezing and storage of cells (Unger et al., 2008). GMP-accredited
production processes are thus an important part of the cell
development process.
