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IND-enabling CMC for Plasmid and Linearized DNA

Fast Turnaround to Meet Your Demanding Timeline

Proven Track Records with over 70 Global IND Clearances

The chemistry, manufacturing, and controls (CMC) information would be used for investigational new drug applications (INDs), which will help the projects move to clinical trials. The amount and depth of CMC information is agency depends. ProBio has rich experience in global IND clearances, including FDA, NMPA, TGA, MFDS, PMDA, CCMO, DRAP, and Ministry of Health, etc., and will be your good partner.

Time-saving Offering
- Ready-to-use LentiHelper™ plasmid and AAssistV™ plasmid to accelerate development
  - FDA DMF registered fasten your IND filing
  - Royalty free, maintenance free
Agency-specific Solution
- Agency-specific solution accelerate your project
  - 2-month FDA/EMA IND Ready CMC from cell banking to pilot scale production release
  - 4-month FAST CMC cell banking to pilot scale production release for MFDS, PMDA, etc.
Proven Track Record
- 70+ global IND clearances from FDA, NMPA, TGA, MFDS, PMDA, CCMO, DRAP, and Ministry of Health, etc. for plasmid and linearized DNA

IND-enabling CMC

Cell Bank

PCB/MCB/WCB
Process Development

Upstream Process Development
Downstream Process Development
Formulation Study
Verification Run
Analytical Development

Analytical Method Development
Analytical Method Qualification

Plasmid Manufacturing

Engineering Run
Pilot Scale Production
Stability Study

Long-term Stability
Accelerate Stability
Influencing Factor Stability
IND Documentation

CTD Format

IND-enabling CMC for Plasmid and Linearized DNA

IND-enabling CMC

Cell Bank

Process Development

Analytical Development

Plasmid Manufacturing

Stability Study

IND Documentation

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