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CMC Development New drug development system with expertise

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CMC Development

Genexine has expertise in CMC development
for innovative new drug development.

Established facility and CMC experts

Facility
· Small scale(3L, 15L)
· Large Scale(50L, 200L)
· Analysis : LC-MS & MS/MS, HPLC-UV/FLD/ELSD, CE & Bioanalysis system
CMC Experts
· Ph.D., Masters, experts
· Scale up(up to 200L)
· Formulation study
· Method Development & Qualification
· Tech Transfer(USP, DSP, Analysis)
· Quality Management System
· CTD documentation(IND, NDA)
CMO & CRO Management
· Cell bank
· DS/DP Manufacturing
· UPB, VC study for IND filing
· Toxicity study
· DS/DP Release, Stability
Process Development Up to Clinical
· Ph2 project 3(KR, US, EU) : GX-I7, GX-H9, GX188E
· Ph3 project 1(KR, Indonesia) : GX-E4

Fully supported biologics platform for clinical

Genexine has process development experiences for clinical trials in KR, US, EU.

ADT

01Cell line
· Support the Cell line Dev.
· Using CMO/CRO
02USP
· Cell culture Dev.
· Scale up (~200L)
· Support the UPB using CRO
· IND/NDA filling
03DSP
· Purification Dev.
· Scale up(~200L)
· Support the VC using CRO
· IND/NDA filling
04Analysis
· Method dev. Of HPLC, CE & Bio assay dev.
· Formulation study
· Experimental study
· Support the CRO/CMO
· IND/NDA filling
· Full Characterization
(Protein, Glycan, Physicochemical Properties, Impurity)
05Non clinical
· Analysis
· Support the toxicity study using CRO
· Method dev. Of Bioanalysis, ADA, and DFA for protein drugs based on the GLP system
GMP
· Support the GMP
· Tech Transfer to CMO
· Review the Batch Record of DS/DP Mfg
· DS/DP Release, Stability Report Review
QA
· Multiple CMO management
· Quality Management System