Quality control of biologicals produced by r-DNA technology.

This manuscript provides suggestions for monitoring the safety, purity, and potency of new drugs and biologics produced by recombinant DNA technology. We discussed: the Expression System, the Master Cell Bank, Production Procedure, Purification Procedure, and Characterization of the Product. These points represent our current concensus of opinion relating to the safe use of recombinant DNA products and should not be regarded as fixed or all-inclusive.