Ultee: Again, having that pilot plant or engineering-run facility is really important for scale-up 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 sort of teach the process to manufacturing and the manufacturing people can also teach the process development people aspects of the large-scale equipment.

BioPharm: What is the role of the analytics group? How can methods transfer from analytical development to quality control be enhanced?

Ultee: 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, like titers in a bioreactors, how much did the cells make, and product quality, in terms of 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 can't really know that. Without good analytics, you are flying blind. So analytics are part of every good process development strategy.

Ultee: There are a couple of routes to it. We do have some distant customers from Europe and Asia. Sometimes they will bundle their travel with some other needs they have on the East Coast of the US where we are located. At other times, we use a lot of teleconferences, and we sometimes do that very early in the morning or late at night to accommodate the time-zone differences. And as one of our Australian customers said, "We are far away from almost everyone, so we understand we have to go a long way to work with you from a time zone and meetings aspect."

This conversation has been edited for length and clarity.

Mike Ultee, is senior director of biopharmaceutical development and operations at Laureate Pharma, Inc., Princeton, NJ, 609.919.3390, michiel.ultee@laureatepharma.com