PROTEIN PRODUCTION: Cell Expression Products

James W. Larkin jamesl at
Thu Sep 25 13:00:52 EST 1997

Cell Expression Products
January 14-15, 1998  San Diego, California

The number of FDA-approved proteins derived from recombinant 
sources has been steadily growing. Manufacturing scale 
processes for such proteins start from a variety of sources 
extending from transgenic animals to mammalian cell cultures. 
The scale of these processes and the number of unit operations 
involved reflect the source organism, the nature of the 
biologically active form of the molecule, and market economics 
for specific classes of proteins. Opportunities under the 
FDA/CBER revisions affecting specified biologicals permit 
alterations in protein source and/or unit operations thus 
allowing manufacturers a changing paradigm from "regulation
by process to regulation by product." Such changes bring the 
need for highly sophisticated analytical technology to the 
production floor.  

For more information, please contact:

Cambridge Healthtech Institute
1037 Chestnut Street
Newton Upper Falls,  MA  02164

Phone: 617-630-1300
Fax: 617-630-1325
e-mail: chi at

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