Plasmid-DNA Production
Services
| Advanced
Plasmids' proprietary process produces high quality plasmid-DNA that is
ahead of its time. We can produce a milligram up to multiple grams of
plasmid-DNA. You can select a predefined grade that meets
appropriate specifications for the intended use or we can develop a
custom grade to meet your unique specifications. Below are the
predefined grades: |
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In
vitro
grade – intended for Research and
Development (aka Transfection grade).
- 1L preps
- We grow and process 1L
of broth and provide you with all of
the purified plasmid.
- These preps are low
Endotoxin and high quality.
- The cost
is $290 per 1L prep.
- Discounts
start when you have more than 20 preps at once.
- Larger
quantities of in vitro grade lots can be ordered.
- These
lots are quoted per request and the price depends on the desired
quantity and
the yield (or predicted yield).
- Click order to start
the quoting/ordering process.
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In
vivo
grade – intended for animal and toxicology studies (aka PreClinical
grade).
- An additional
chromatography step is added to
the process so these lots meet more stringent quality specifications.
- These
lots are quoted per request.
- Click order to start
the quoting/ordering process.
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GMP-source grade – intended as a critical raw material
for a clinical grade product.
- Our
GMP-Source plasmid service has been designed to produce
well-characterized
plasmid DNA for use in a GMP process.
- This
service is for any organization that is using transient transfections
to
produce a clinical-grade product.
- This
service has been used to make GMP grade AAV viruses and GMP grade
proteins.
- This is a
cost effective alternative to full-scale cGMP production.
- Email info@advancedplasmids.com
if you are interested in learning more.
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GMP-source
for Phase-1
studies
Since the
FDA’s rule in July 2008 that makes most Phase 1 drugs exempt from cGMP
requirements, our GMP-Source service could be used to make plasmid-DNA
for
Phase-1 studies. This is a
cost effective alternative to full-scale cGMP production. We would
certainly welcome audits and this service would meet all the
requirements
described in the new guidance
document.
Email info@advancedplasmids.com
to learn more.
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Pharmaceutical grade – intended for clinical
applications (aka cGMP grade).
- Transfer our large-scale pharmaceutical grade process
to your facility.
- This service has
several phases:
- First we demonstrate
our process by performing several small-scale runs.
- Then we perform
several larger-scale production
runs.
- Then we provide the
client
with batch records and on-site support and training.
- Partner's facility
- We can also pass our
clients to a partner with a full cGMP facility.
- Email info@advancedplasmids.com
if you are interested in learning more.
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