Cultured primary fetal cells from one organ donation could possibly meet the exigent
and stringent technical aspects for development of therapeutic products. These cell types
have fewer technological limitations for cellular proliferation capacity (simple culture
conditions) and maintenance of differentiated phenotype, and they also have low
probability for transmission of communicable diseases. Master and Working Cell Banks
(MCB, WCB) can be obtained from one fetal organ donation, permitting multiple tissues
(skin, bone, cartilage, muscle and intervertebral disc) to be processed in short periods of
time with identical methods to assure a stringent tracing of the processes for the
production of standardized therapeutic agents. Clinical use of biologics from embryo and
fetal tissues is relatively new and current legislation and ethics have some differences
between countries to date. In addition, specific cell delivery systems for each tissue type
can be adapted to the clinical application. Since it is the intention that banked primary
fetal cells enhance the prospective treatment of hundreds of thousands of patients with
only one organ donation, it is imperative to show consistency, traceability and safety of
the processes including donor tissue selection, cell banking, cell testing and growth of
cells in out-scaling for the preparation of bio-engineered products for clinical application.