Option B. The use of the chemically defined R media requires additional development and optimization of the titer and purification yield for the AFAIK2. This is based upon the results of the two 20L fermentation trials performed to date. Prior to scaling the fermentation to the next stage there are a certain number of activities that must be undertaken to assure the process for the production of AFAIK2 at the 500L scale will support the current stage of the project. These activities are summarized below, I. Repeat the R media shake flask experiments II. R media test fermentation at 20-30L fermentor scale III. Purification of AFAIK2 to confirm yield from 20-30L scale.
Appears in 3 contracts
Sources: CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp), CGMP Process Development, Scale Up and Clinical Supplies Manufacturing Agreement (Helix BioPharma Corp)