Well-Characterized
Plasmid DNA
Aldevron's 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 (e.g. GMP
AAV production and clinical-grade protein
production). Regulatory agencies do not require that plasmid DNA used
as a manufacturing component in a clinical grade process be produced
itself in a GMP setting. Aldevron has designed this system to offer
you an accelerated, cost-effective alternative to full-scale GMP plasmid
manufacturing.
Plasmid DNA:
- Production and quality
program designed to produce ancillary
plasmid DNA for clinical-grade AAV production and for any GMP process
that requires transient transfections.
- Plasmid DNA delivered with an
extensive Manufacturing Summary Report
to meet FDA requirements.
- A cost-effective
alternative to full-scale GMP production.
Highlights of Aldevron's GMP-Source
Service include:
- Host-cell optimization and cell banking.
- Fermentation and purification
processes free of animal components.
- Final
production in class 10,000 and class
100 clean rooms.
- Documented product
segregation.
- Traceability of all raw
materials.
- Comprehensive QA/QC documentation
and a complete Manufacturing Summary
Report to meet FDA requirements.
cGMP Plasmid Production
Aldevron's plasmid production system is scalable to cGMP production. Please contact us for more details. We would be happy to discuss the logistics of your project and to arrange an on-site audit. With our GMP-Source(tm) service, we can provide contract manufacturing solutions and a seamless transition from research to market supply.
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