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Plasmid Manufacture

Delivered Better, Delivered Fast

Flexible Capability in China and The US

Plasmid Manufacture

To accelerate the development path of CGT, ProBio is dedicated to produce plasmid DNA with advanced technologies and an experienced team. The services cover from the preclinical plasmid preparation, through the IND application, clinical phases and BLA, to commercial plasmid manufacturing.

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 sourced
Strong Track Record: from NMPA to FDA, from IND to BLA, from cell therapy to gene therapy and mRNA
“Purer” GMP plasmid manufactured & delivered in less than half of market lead-time
Harness Personal Client Care: flexible CDMO capabilities, giving better customer experience
Various Applications: CAR-T, TCR-T, CAR-NK, CRISPR editing cell therapy, Gene therapy, mRNA vaccine, Virus vaccine, DNA vaccine, LcDNA
Dual Plasmid Manufacturing in China and the US

Plasmid Manufacturing Service

IND

Phase I

Phase II

Phase III

BLA

Commercial

IND CMC

GMPro^TM Grade

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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