비티젠

팝업레이어 알림

Manufacturing Trust,Expanding Worldwide

Manufacturing Trust, Expanding Worldwide

Manufacturing Trust, Expanding Worldwide

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

비티젠의 시설을
360° 버추얼 투어를 통해
공정별로 체험할 수 있습니다.
자세히보기

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

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