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 documentation, as well as the process. What we have learned is that the process development people can teach the process to manufacturing, while the manufacturing people can also teach the process development people aspects of the largescale equipment. What is the role of the analytics group? How can methods transfer from analytical development to quality control be enhanced? The analytics staff are really the eyes and ears of the development and manufacturing groups because what they provide is the key information that you need, such as titers in bioreactors, how much did the cells make and product quality — how much contaminant is removed in each step of the purification process, or was the protein inadvertently damaged or aggregated by a particular process step? Without the analytics group, you ca
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