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Plasmid CMC

Dual Plasmid Manufacturing in China and The US

>60 INDs Approved from NMPA, FDA, PMDA, MFDS, CCMO and Ministry of Health

Plasmid CMC for IND

Pharmaceutical research is known to be one of the key steps for IND submission. ProBio provides a one stop solution service in pharmaceutical research from plasmid construction with compliance gene synthesis to IND filing (NMPA, FDA, MFDS, Ministry of Health, etc.) in various applications. The company uses its expertise experience to assist customer’s project in entering next clinical stage.

One Stop Solution for IND Filing

Regular CMC

FAST CMC

FDA/EMA IND Ready CMC

Cell Banking

Process Development (PD)

Small Scale Production

Pilot Scale Production

Small Scale Production

Project Specific Qualification (PSQ)

Stability Study

Analytical Development (AD)

Pilot Scale Production

IND Documentation

Pilot Scale Production

Stability Study

IND Documentation

Project Experience

CAR-T, TCR-T
CAR-NK
CRISPR editing
AAV based therapy
mRNA vaccine
Virus vaccine
DNA vaccine
…

Technical Advantages

Strains & helper plasmids

Strains

Licensed strains with sublicense

Ready-to-use helper plasmids

DMF registered at FDA CBER
Clear history and IP free
Royalty free, maintenance free

Application

CGT: Ready-to-use LentiHelper^TM plasmids for 3^rd generation LVV packaging and AAssistV^TM plasmids for AAV packaging
mRNA: Experience with plasmids with poly A tail length from 70 bp to 150 bp
DNA vaccine: high concentration for effective application

Plasmid CMC

Plasmid CMC for IND

One Stop Solution for IND Filing

Project Experience

Technical Advantages

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