S63: Scale Free Manufacturing Model using Perfusion

Tuesday, August 13, 2013: 10:00 AM
Nautilus 5 (Sheraton San Diego)
Gael Peron1, Wilson Lee1 and Olivier Berteau2, (1)Charter Medical, Ltd, Winston-Salem, NC, (2)APIcells Inc, Lowell, MA
Perfusion, when it’s well managed, offers many economical and performances advantages.

Unfortunately, perfusion is often perceived as too complex, and perfusion devices thought to be too expensive and likely to clog; achieving higher productivity without a long, costly investment and optimization of the process and scale-up are seen as difficulties; Industry believe no process control can truly manage perfusion; and finally it is known that set-up is too long, complex, and has too many risks of contamination if you are not a perfusion expert.

This presentation is a breakthrough for cell culture experts who believe in perfusion
model and scale-up of such model.

From process development to production we are proposing a different model where
scale-up and its management difficulties are by-passed. 

Same equipment, same model, same process design from process development to
continuous manufacturing at commercial scale will be explained during this presentation.

This innovative and unique method of perfusion control leads to a new process developmentconcept and manufacturing process design for mAbs and therapeutic proteins.