Question on FDA regulation regarding Ampicillin

N490047 at UNIVSCVM.CSD.SCAROLINA.EDU N490047 at UNIVSCVM.CSD.SCAROLINA.EDU
Tue Aug 29 14:02:16 EST 1995


Hi,
I am working for a small biotech company.  We have severals proteins isolated
from soil bacteria that have good therapeutic potential.  We have cloned the
genes that encode these proteins and have overexpressed them in E. coli. We
are interested in producing large quantities of these proteins in a GMP
facility so that we could use them in clinical trials.  I would like to the
know the FDA regulation regarding the use of E. coli for the production of
therapeutic proteins.  Are there any restiction regarding the type plasmid
used, type promoter used, type induction used etc.  Also is it true that
antibiotic selection cannot be used during fermentation if the drug is
injectable?  Is this restriction applicable only for ampicillin or to other
antibiotics as well?  Thanks in advance for your help.
natarajan



More information about the Microbio mailing list