M.J. Welsh and A.E. Smith, RAC Application 
B.l.b. What is the structure of the material that will be administered to the patient? 
B.l.b.(l) Describe the preparation, structure, and composition of the materials that will be 
given to the patient or used to treat the patients' cells. 
B.l.b.(l)(a) If DNA. what is the purity (both in terms of being a single DNA species and in 
terms of other contaminants')? What tests have been used and what is the sensitivity 
of the tests? 
Not applicable 
B.l.b. (l)(b) If a virus, how is it prepared from the DNA construct? In what cell is the virus 
grown (any special features)? What medium and serum are used? How is the virus 
purified? What is its structure and purity? What steps are being taken (and assays 
used with their sensitivity) to detect and eliminate any contaminating materials (for 
example. VL30 RNA. other nucleic acids, or proteins) or contaminating viruses (both 
replication-competent or replication-defective) or other organisms in the cells or 
serum used for preparation of the virus stock including any contaminants that may 
have biological effects? 
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Recombinant DNA Research, Volume 16 
