DEFINITION

Sipuleucel-T is an autologous cellular immunotherapy. The active components of sipuleucel-T are autologous antigen presenting cells (APCs) and a recombinant protein, PAP-GM-CSF that consists of human prostatic acid phosphatase (PAP) fused through the C-terminus to the N-terminus of human granulocyte-macrophage colony-stimulating factor (GM-CSF) by a Gly-Ser linker. PAP is an antigen expressed in prostate cancer tissue and GM-CSF is an immune cell activator. Minimal residual levels of the intact PAP-GM-CSF are detectable in the final product.