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Think Quality First

Link with STgen Bio, Your Global CMO Partner

Sync Global Standards

Link with STgen Bio, Your Global CMO 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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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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Fully Integrated CMO Service
STgen Bio People

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