Manufacturing Trust,Expanding Worldwide

Think Quality First

Link with BTGEN, Your Global CDMO Partner

Sync Global Standards

Link with BTGEN, Your Global CDMO Partner

Fully Integrated CMO Service

BTGEN
DS Manufacturing

Highly Efficient
Process Operations
by Hybrid System

BTGEN
DP Manufacturing

Fully Automatic
Pre-Filled Syringe Line

BTGEN
Analytical Testing

Comprehensive
and Accurate

BTGEN
Quality Management System

in Compliance with Global
Regulatory Requirements

비티젠VR

360° Virtual
Facility Tour

Explore BTGEN’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
BTGEN

Process Development

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

Technology Transfer

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

Scale-up Engineering

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

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
BTGEN

cGMP DP Manufacturing

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

Analytical Testing

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

Regulatory Services

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

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