PROTEIN PRODUCTION
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
USA
Phone: 617-630-1300
Fax: 617-630-1325
e-mail: chi at healthtech.comhttp://www.healthtech.com/conferences/