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Old Title vs

NIH Guidelines
for Research
Involving
Recombinant
DNA Molecules
New Title



NIH Guidelines
for Research
Involving
Recombinant or
Synthetic
Nucleic Acid
Molecules
Implement by
3/3/13
Is chemical synthesis covered?
synthesizer
Not until in a …
III-F Registrations

Nothing exempt in Boston




BPHC adopts updated Guidelines
unless…
Using nonhazardous plasmids (pBR) to
clone gene of interest into host
(nonpathogenic E.coli)
Often the first step in creating a
transgenic animal
New exemptions for synthetic NA

No origin of replication, no integration…
NIH Guidelines: Definition of rNA


Molecules
constructed by
joining nucleic
acids
& can replicate in
a living cell
NIH Guidelines: synthetic

Nucleic acids
that can base pr
w naturally
occurring
nucleic acids
NIH Definitions Continued

Molecules
resulting from
replication of
rNA or synthetic
nucleic acids in
past two slides
Other Changes



Fewer AAV serotypes need review
Transfer of drug resistance traits
Human Gene Transfer w nucleic
acids
Risk Assessment & Synthetics


% of genome from each parent
Fn/purpose of each sequence


Assume same fn as original host?
Synergism between sequences &
transgenes
What Next? - XNA



~6 sugars can
form NA bbone
Store & retrieve
genetic info
Medical benefit?
Slower
breakdown in
stomach &
bloodstream
Real World Examples


iGEM 2006
Jay Keasling
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