에스티젠바이오

Succeeding togetherLink with STgen Bio

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

Process Development

Cell line development
USP development
DSP development
Formulation development
Analytical method development

Technology Transfer

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

Scale-up Engineering

DS / DP engineering runs
Release test
Preliminary DS / DP stability test

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

cGMP DP Manufacturing

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

Analytical Testing

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

Regulatory Services

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

Fully Integrated CMO Service
STgen Bio People

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