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6.2 GMP Principles
First, it is necessary to mention that GMP guidelines are not instructions or proce-
dures to produce or manufacture any specifi c product. In fact, GMP guidelines are
a series of principles that must be fulfi lled during the manufacturing process. The
application of GMP guidelines during the manufacturing process will not only
result in high-quality products but also maintain the quality from lot to lot. Similar
to medical production, cell-based products are also regulated as medicines and must
comply with GMP.
However, cell-based products have different properties compared with medicines
as follows. (1) Cell-based products are live cells; (2) these products require special
methods for storage and transportation; (3) it is diffi cult to decontaminate bacteria,
fungi, and viruses; (4) product quality is diffi cult to control; and (5) it is diffi cult to
scale up the manufacturing procedure. Some cell-based products are considered as
personalized medicine produced to apply to only one patient. Therefore, stem cell-
based products are divided into two groups: (1) personalized medicine in which
isolated stem cells from patients are reinjected into themselves and (2) stem cell
drugs developed from stem cells to treat diseases in groups of patients. Personalized
medicine is autologous transplantation of stem cells, whereas stem cell drugs are
allogeneic transplantation of stem cells.
Fig. 6.2 Clinical trials using MSCs (clinicaltrials.gov). The number of clinical trials using MSCs
dramatically increases from 2007 to date. In 2015, the number of clinical trials was recorded to
June 2016
P.V. Pham and N.B. Vu