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Plasmid Manufacture

• Licensed Strain with Sublicensed Authority

• Strong Track Record – IND approved from NMPA to FDA

Plasmid Manufacture

To accelerate the development path of gene and cell therapy, GenScript ProBio is dedicated to produce plasmid DNA, including lentiviral plasmid etc., for gene and cell therapy with advanced technologies and an experienced team. Our team has capability and confidence to provide you with the best service from the preclinical plasmid preparation, through the IND application, clinical phases (GMPro^TM Plasmid DNA), and BLA, to the manufacture of commercial plasmids (GMP Plasmid DNA).

Plasmid Manufacturing Process

Plasmid Construct

Fermentation

Harvest

Lysis

Chromatographic Purification

Quality Control and Release

Plasmid Platform – Excellent Track Record & Strong IP

Licensed Strain with Sublicensed Authority, clear IP and history, proprietary PowerS^TM-ITRrs strain for AAV transfer plasmid
Internal & Compliance gene synthesis for plasmid construction, Clear History, Time and Cost Saving
Strong Track Record: from NMPA to FDA, from IND to BLA, from cell therapy to gene therapy and mRNA
Various Applications: CAR-T, TCR-T, CAR-NK, CRISPR editing cell therapy, Gene therapy, mRNA vaccine, Virus vaccine, DNA vaccine, LcDNA

Plasmid Manufacturing Service

IND

Phase I

Phase II

Phase III

BLA

Commercial

IND CMC

GMPro^TM Grade
（including FAST MFG.）

GMP Grade

BLA PC/PV

GMP Grade

	GMPro^TM Plasmid (Raw Material)	GMP Plasmid (Raw Material, DS, DP)
Animal Free	√	√
Antibiotic Free	√	√
Fermentation Process	√	√
Alkaline Lysis	√	√
Chromatographic Purification	√	√
CoA (QC Report)	√	√
TSE/BSE Statement	√	√
Manufacturing Summary Report	√	√
E. coli Cell Banking	√	√
Process Development, At-Scale Engineering Run		√

Plasmid Manufacture

Plasmid Manufacture

Plasmid Manufacturing Process

Plasmid Platform – Excellent Track Record & Strong IP

Plasmid Manufacturing Service

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