Does using a pilot plant change the process significantly?
Yes it does, and it has a couple of benefits that aren’t immediately apparent if you don’t have this kind of facility that is dedicated to producing engineering runs. By putting that in place, we created a nice spot where we could transfer the technology in a hands-on fashion between the development and the manufacturing staff at Laureate Pharma (NJ, USA). We can also have the client present, as we have always encouraged them to be. When we designed the plant, we put in large viewing windows so that the client could be on the outside, without having to gown up, and still be able see the process and check on it periodically. This way, the person in the plant can interact more easily with us. How can a biopharmaceutical company efficiently handle the scale-up aspect of technology transfer? Again, having that pilot plant or engineeringrun facility is really important for scaleup because it allows people in the key development and manufacturing groups to work together on their documentatio
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