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Plasmid CMC

• One stop solution for IND filing

• >40 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

Stages	Regular CMC	FAST CMC	FDA/EMA IND Ready CMC
Cell Banking	√	√	√
Process Development (PD)	√	NA	NA
Small Scale Production	√	√	NA
Analytical Development (AD)/Project Specific Qualification (PSQ)	√	√	NA
Pilot Scale Production	√	√	√
Stability Study	√	√	√

Project Experience

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

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 (over 15 projects)
DNA vaccine: high concentration (20 mg/ml) for effective application

Related Service

Plasmid Manufacturing

LentiHelper^TM Plasmid Products

Linearized DNA Manufacturing

AAV CMC for IND

Contact us

Phone: 1-877-436-7274 (Toll-Free); 1-732-885-9188

Fax: 1-732-210-0262