Attachment VI - Paae 6 
8 
(3) Describe the steps used to derive the DNA construct. 
b. What are the structure and ccmposition of the material that 
will be administered to the patient? 
(1) Describe the preparation, structure, and ccmposition of the 
materials that will be given to the patient or used to 
treat the patient's cells. 
(a) If INA, vhat is the purity (both in terms of being a 
single DNA species and in terms of other contaminants ) ? 
Vhat tests have been used and vhat is the sensitivity 
of the tests? 
(b) If a virus, how is it prepared fron the ENA construct? 
In vhat cell is the virus grown (any special features)? 
What medium and serum are used? How is the virus 
purified? Vhat is its structure and purity? Vhat 
steps are being taken (and assays used with their 
sensitivity) to detect and eliminate any contaminating 
materials (nucleic acids, proteins, etc.) or contaminating 
viruses or other organisms in the cells or serum? 
(2) Describe any other material to be used in preparation of 
the material to be administered to the patient. For example, 
if a viral vector is proposed, vhat is the nature of the 
helper virus or ceil Line? If carrier particles are to be 
used, vhat is the nature of these? 
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