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The goal of Quality Systems is to consistently produce that Demonstrated to be safe and effective in studies.
The platform of process development (PD) aims to transform the project stage from drug discover to GMP production. Our platform is composed of platform of plasmid and platform of AAV. QbD is performed in the PD of plasmid and AAV to obtain desired levels of productivity and quality, and the process would be provided with compliance, ability of scale-up and robustness.
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Platform of Plasmid PD
Cell-line Development（CLD）:
*Screening of efficient strains
*Screening of stable clones and Cell bank
*Medium development of E.coli
Upstream Processing（USP）:
* Plasmid PD
* Plasmid scale-up study
* Process characterization
Downstream Processing（DSP）:
* Plasmid PD
* Plasmid scale-up study
* Process characterization
Platform of Plasmid PD
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Platform of AAV PD
Cell-in Development（CLD）:
*Cell adaption
*Screening of efficient cells
*Screening of stable clones and Cell bank
*Medium development of HEK293
Upstream Processing（USP）:
*AAV PD
* AAV scale-up study
* Process characterization
Downstream Processing（DSP）:
* Plasmid PD
* Plasmid scale-up study
* Process characterization
Platform of AAV PD
