Leukapheresis of healthy volunteer donors for T cell study and TolDC production process validations

Cellular immunotherapy via adoptive transfer of in-vitro selected or generated
cell therapy products is a new and expanding field for several clinical
indications. Basic scientific findings are translated via translational
research projects into protocols for the production of cell therapy products
under strict Good Manufacturing Practice (GMP) conditions. Before production of
cell therapy products for real clinical application can take place, the
procedures need to be validated and testruns need to be performed.

To obtain fresh mononuclear cells from healthy volunteer donors to be used for
validation of procedures for the generation of GMP-grade T cell or tolerogenic
dendritic cell products for clinical application.

Mononuclear cells (from which T cells and monocytes can be isolated) will be
collected from healthy volunteer adult donors using an apheresis procedure.

There is no potential subject benefit from participation in this study. Burden
for the subjects consists of 2 visits to the apheresis department, 2
collections of blood samples, and a 2-3 hour apheresis procedure. Potential
complications are non-severe, well known and easily managed.