Program:
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.
Registration :
Cambridge Healthtech Institute
1037 Chestnut Street, Newton Upper Falls, MA 02164
Tel: 617-630-1300 Fax: 617-630-1325
E-Mail: chi@healthtech.com
Deadline for Abstracts: Dec. 6, 1997
Email for Requests and Registration: chi@healthtech.com