ArmaGen Technologies has selected PacificGMP to produce its treatment for stroke or Parkinson's disease for a Phase I trial. PacificGMP will use a perfusion process to produce the antibody fusion protein, AGT-190, under cGMP standards. Additionally, PacificGMP will perform cGMP cell bank development.
The AGT-190 fusion protein is a bi-functional molecule: It attaches to a receptor on the human blood-brain barrier (BBB) to effect transport into the brain from blood, and it attaches to a specific neurotrophin receptor on brain cells to protect the cells from cellular damage. AGT-190 comprises a human neurotrophin that causes neuroprotection in the brain. Since the neurotrophin cannot cross the BBB, it is thus fused to another protein that undergoes receptor-mediated transport across the human BBB. The second protein acts as a molecular Trojan horse to ferry the therapeutic neurotrophin across the BBB.
PacificGMP points out that using the perfused method of manufacturing provides significant economic and timeline advantages. Perfusion is a production technology whereby culture media containing the drug product is continually harvested while the bioreactor is replenished with fresh media containing essential nutrients. The result is a dense cell culture able to produce necessary yields using a smaller bioreactor size compared to a traditional batch or fed-batch process.