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.
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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
- Ready-to-use LentiHelper™ plasmid and AAssistV™ plasmid to accelerate development
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Agency-specific Solution
- Agency-specific solution accelerate your project
- 4-month FDA/EMA IND Ready CMC from gene synthesis to IND filing
- 6-month FAST CMC from gene synthesis to IND filing for MFDS, PMDA, etc.
- Agency-specific solution accelerate your project
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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
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Cell Bank
PCB/MCB/WCB
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Process Development
Upstream Process Development
Downstream Process Development
Formulation Study
Verification Run -
Analytical Development
Analytical Method Development
Analytical Method Qualification
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Plasmid Manufacturing
Engineering Run
Pilot Scale Production -
Stability Study
Long-term Stability
Accelerate Stability
Influencing Factor Stability -
IND Documentation
CTD Format
