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Plasmid & Nucleotides
Plasmid & Nucleotides
Development and Manufacturing for your cGMP plasmid
With extensive expertise in the development of customized plasmid DNA manufacturing solutions, we provide plasmid services from process development to large-scale cGMP manufacturing. We also provide process development and cGMP manufacturing services for nucleotide products including mini-circle plasmid and mRNA.
 
1
Plasmid Construction
Plasmid construction from the target gene sequence or relevant plasmid
2
Strain Bank Construction
Construction of primary, master, and working strain banks Development of process and analytical procedures
3
Process and Analytical Method Development
Upstream process development, downstream process development, and analytical method development
4
GMP Run - Upstream Process
Fermentation at 50 L to 100 L in bioreactor
5
GMP Run - Downstream Process
Automated and fully closed purification process
6
Aseptic Fill and Finish
Aseptic isolator under automatic Class-A environment
7
Quality Control and Release
Quality control system in compliance with regulatory requirements
8
Deliverables
Package including plasmid product, seed bank, Certificate of Analysis, batch production record, batch inspection record, and relevant Chemistry Manufacturing and Control (CMC) dossier
Why OBiO?
10+ years of dedication to gene and cell therapy
Track record of >100 gene and cell therapy projects
Compliant manufacturing for successful initiation of multi-center clinical trials
Comprehensive quality system with regulatory compliant facilities
Sufficient capacity and state-of-the-art facilities for global manufacturing needs
End-to-end professional project management for in-time supports and on-time delivery
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