Gene therapy vector post-production sequencing is unnecessary, BIO tells advisory committee.
GENE THERAPY VECTOR POST-PRODUCTION SEQUENCING IS UNNECESSARY, BIO ASSERTS during a discussion of FDA's "Addendum to the Points to Consider in Human Somatic Cell and Gene Therapy" at the Feb. 29 meeting of the Biological Response Modifiers Advisory Committee. "Only unknown sequences and sites of ligation in the creation of a new vector should be sequenced by the manufacturer," Biotechnology Industry Organization Director of Technical Affairs Alan Goldhammer, PhD, suggested.
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