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

エスティジェンバイオの施設を
360度バーチャルツアーで
工程別に体験することができます

詳細へ

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
에스티젠바이오

Regulatory Services

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

STgen Bio People

クォン・ユラ
シニアマネージャー

DS製造チームエスティジェンバイオ 生産ユニット

イ・チェヨン
ジュニアマネージャー

DS製造チームエスティジェンバイオ 生産ユニット

ソン・ギボム
シニアマネージャー

品質保証チームエスティジェンバイオ 品質ユニット

ヤン·ヒョクジン
ジュニアマネージャー

設備管理チームエスティジェンバイオ 経営ユニット

ラ・ギユン
ジュニアマネージャー

品質管理チームエスティジェンバイオ 品質ユニット

イム・ジヒェ
チーム長

ITチームエスティジェンバイオ 経営ユニット

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