In order to be tested in patients, APO-1 (APOSECTM) and APO-2 (APOSECTM) need to be manufactured under extremely strict quality standards following the principles of Good Manufacturing Practice (GMP) prescribed by regulatory agencies worldwide. Aposcience AG works closely together with the Blood Donation Service of the Upper Austria Red Cross in Linz (Primarius Dr. Christian Gabriel, Administrative Director Mag. Werner Watzinger), which has amassed very significant experience in the field of blood derived and cell based therapeutic products.
Since there is no pre-defined regulatory pathway for the product, the company and its collaboration partners will interact closely with regulators, initially with the Austrian AGES and the European Agency EMA, using discussion pathways established for such highly innovative products.
The GMP production process for allogeneic and autologous APOSEC was successfully established at the Blood Bank Linz and approved by the Austrian Health Authority AGES on 25 April 2014.