Hi,
I am getting ready to have a protein produced for clinical trials. I
understand that as a first step I have to establish a Master Cell Bank of the
E. coli strain harboring the expression construct. I am not fimiliar with the
FDA regulations and common industrial practices that I should consider for
undertaking such a project. We are a small company with limited financial
resources at our disposal and hence would like to take the least expensive
way to accomplish our objective. I would greatly appreciate if someone
fimiliar with this kind projects would give me some direction. Thanks in
advance for your help.
Natarajan
