Succeeding togetherLink with STgen Bio

Think Quality First

Link with STgen Bio, Your Global CDMO Partner

Sync Global Standards

Link with STgen Bio, Your Global CDMO Partner

Fully Integrated CMO Service

STgenbio
DS Manufacturing

Highly Efficient
Process Operations
by Hybrid System

STgenbio
DP Manufacturing

Fully Automatic
Pre-Filled Syringe Line

STgenbio
Analytical Testing

Comprehensive
and Accurate

STgenbio
Quality Management System

in Compliance with Global
Regulatory Requirements

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360° Virtual
Facility Tour

Explore STgen Bio’s
facilities through
our 360° virtual tour.

Details

One-Stop CDMO Service

Project Management System

  • Real-time monitoring
  • Dedicated project management for entire project lifecycle
  • On-time project deliverables
  • Project managers open to negotiation
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Process Development

  • Cell line development
  • USP development
  • DSP development
  • Formulation development
  • Analytical method development
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Technology Transfer

  • Technology transfer from client
  • Scale-up process design
  • Analytical method transfer
  • Analytical method validation
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Scale-up Engineering

  • DS / DP engineering runs
  • Release test
  • Preliminary DS / DP stability test
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cGMP DS Manufacturing

  • USP : Mammalian cell culture max. 2,500L
  • DSP : Chromatography, UF/DF
  • Clinical, PPQ, and commercial manufacturing
  • Single-use and multi-use platform
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cGMP DP Manufacturing

  • Pre-filled syringe filling
  • Blister and carton secondary packaging
  • Serialization and aggregation
  • Lot release, cold chain shipping
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Analytical Testing

  • Physicochemical, microbial, cell-based testing
  • Raw materials testing
  • DS / DP release testing
  • Stability program
  • Similarity, comparability testing
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Regulatory Services

  • Regulatory document support
  • MFDS (KR), PMDA (JP), MoH(TR) GMP approval
  • FDA, EMA approval (planned in 2023)
  • Product lifecycle management
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STgen Bio People

Yura Kwon
Senior Manager

DS Manufacturing TeamProduction Unit

Chaeyoun Lee
Junior Manager

DS Manufacturing TeamProduction Unit

Kibum Son
Senior Manager

QA TeamQuality Unit

Hyukjin Yang
Junior Manager

Engineering TeamAdministration Unit

Kiyun Ra
Junior Manager

QC TeamQuality Unit

Jihye Lim
Lead Manager

IT TeamTeam Lead

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