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
10+ years of dedication to gene and cell therapy
130 process development projects 230 analytical methods developed
Quality-driven team of experts with in-time responding
Efficient technology transfer with optimizing process validation
Process development versatility for various product needs stages
End-to-end regulatory support with side-by-side navigation
