Genetic Stability and Recombinant Product Consistency

A committee of U.S. industry scientists from the Pharmaceutical Manufacturers Association has reviewed the recent suggestions of Galibert and Center for Biologics Evaluation and Research (CBER) regarding assurances of product consistency by cloning and sequencing efforts. We disagree that their proposals will achieve this goal, and estimate that such efforts will be very costly in terms of regulatory agency time examining artifactual errors as well as industry resources. We feel that current analytical and manufacturing technology is adequate to assure recombinant product consistency without the suggested cloning and sequencing measures.