Bayer Pharmaceuticals Corporation

Bruce Gardner

William H Kelsey

Mokhtar Mered

Rudiger Heidemann

De Qian Wang

The invention is a novel cell freezing and storage bag assembly and method for using the assembly in the seed train expansion of mammalian cells. The bag is constructed principally of polytetrafluoroethylene fabric. The bag is designed to hold enough cells that a bioreactor can be inoculated directly. The bag is designed to be filled to a fraction of its maximum capacity so that the cell suspension has a very thin cross-section (less than about 10 millimeters). The bag design includes a transfer set that can be sterilely welded to the source of the mammalian cells. This sterile-weldable transfer set allows the bags to be filled quickly with minimal risk of contamination. In the method, once each bag is filled, it is sealed below the connection with the transfer set and the bag is cut &ldquo;above&rdquo; the new seal (on the same side of the seal as the transfer set). When a bioreactor is to be inoculated, the contents of the bag are drained via a sterile-weldable inoculation line. During freezing and storage, the inoculation line is protected from mechanical damage.

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El Cerrito, CA, United States of America

Bruce Gardner