Recombinant DNA Advisory Committee - 03/1-2/93 
Dr. Geiduschek recommends that the report be accepted as guidance for investigators, 
and that it should not be included in the Points to Consider. 
Presentation- Dr. Anderson 
Dr. Anderson reiterated that fact that the report encompasses ongoing studies, and that 
these studies are being closely coordinated with the FDA. 
Comments-Dr. Gunter 
Dr. Kurt Gunter, Acting Deputy Director of the Division of Cell and Gene Therapy, 
FDA, stated that the FDA agrees with most of the conclusions presented in the report. 
The one area that the FDA is not entirely in agreement is with the quantitation of risk. 
The FDA feels that a number of assumptions have been made with regard to this issue 
and prefers to rely on empirical data rather than assumptions. 
During the December 1992 RAC meeting, Dr. Arifa Khan of the FDA presented the 
FDA's recommendations for a variety of assays for the detection of RCR at various time 
points in the production process. The reactions of various individuals to the FDA's 
recommendations illustrates the problems that the FDA has had in dealing with the 
public. The FDA does not want to outline requirements that are not scientifically 
founded. However, the FDA is responsible for providing investigators with what is 
considered the state-of-the-art in terms of RCR testing. As a result, the FDA has 
devised recommendations that are based on current scientific data and common sense. 
The FDA's recommendations are as follows: 
o Master cell bank characterization 
Supernatant test 
Co-culture with permissive cell line 
o Manufacturer's working cell bank characterization 
Repeat test for RCR 
Test of transduced target cells (high MOI) 
o Release test of production lots 
Supernatant test 
Co-culture with permissive cell line 
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Recombinant DNA Research, Volume 17 
