바이오 리서치 연구소 전문성을 바탕으로 한 신약개발시스템

제넥신의 바이오 연구소는
혁신 신약 개발에 집중하고 있습니다.

시설 및 CMC 전문가 확보

· Small scale(3L, 15L)
· Large Scale(50L, 200L)
· Analysis : LC-MS & MS/MS, HPLC-UV/FLD/EELSD, 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, India) : GX-E4

임상을 위해 지원되는 생물학적 제제 플랫폼

제넥신은 한국, 미국, 유럽에서 임상시험 공정 개발 경험을 보유하고 있습니다.


01Cell line
· Support the Cell line Dev.
· Using CMO/CRO
· Cell culture Dev.
· Scale up (~200L)
· Support the UPB using
· CRO/IND/NDA filing
· Purification Dev.
· Scale up(~200L)
· Support the VC using
· CRO/IND/NDA filing
· Method dev. Of HPLC, CE & Bio assay dev.
· Formulation study
· Experimental study
· CMO/IND/NDA filing
· 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
· Support the GMP
· Tech Transfer to CMO
· Review the Batch Record of
· DS/DP Mfg
· DS/DP Release, Stability Report Review
· Multiple CMO management
· Quality Management System