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GMP Viral Vector Manufacturing
GMP Viral Vector Manufacturing
ProBio Provides High-quality Viral Vector
Your programs are important, and your time is valuable. ProBio is a responsive and reliable CDMO
partner of viral vector for pre-clinical, clinical and commercial use. We are ready to support you to
deliver life changing therapies.
Viral vector
Capacity
ProBio has proven experience with an extensive
range of viral vector projects
Lentiviral vector for cell therapy and gene
therapy
Our viral vector facility has the capacity and
state-of-the-art technologies to accelerate your
gene or cell therapy development and manufacturing.
2,000 m2 GMP cleanroom suites at Grade A
and C, BSL-2
Retroviral vector for cell therapy
AAV for gene therapy
Adherent viral vector production: Up to 96L
Suspension single use bioreactor: Up to 200L
F&F Speed up to 2,400 vials per hour
(2R/6R/15R)
Capability
Regardless of the virous of viral vector, you can
count on reliable viral vector for pre-clinical,
clinical and commercial uses with either adherent
or suspension process
GMP suites specifically designed for maximum
productivity and efficient production
Integrated One-stop CDMO Solution: Preclinical to GMP
Manufacturing
4-month IND ready
Crude titer up to 1E+8TU/ml
Pre-Clinical
Pre-IND IND-Enabling
Clinical
Late Clinical
BLA/Commercial
GMP
Early Clinical
BLA
LVV packaging: LentiHelperTM plasmid
and PowerSTM-293T cell line with FDA
DMF
Starting material manufacturing
Drug substance manufacturing
Drug product manufacturing
QC release
Process characterization
Analytic method validation
Process validation including PPQ
Starting material GMP manufacturing
Drug substance GMP manufacturing
Drug product GMP manufacturing
QC release
AAV packaging: AAssistVTM plasmid and
PowerSTM-293 cell line with FDA DMF
RVV packaging system
Stability study
PCB/MCB/WCB
Process development
Stability study
Analytical method development
Stability study
Demo run/engineering run/GMP run
Pro Viral Vector
GMP Viral Vector
Clinical GMP Viral Vector
ProBioCDMO.com
+1-732-885-9188
Accelerating Ideas. Delivering Impact.
BLA PC/PV Study: 10~12 Months
Timeline (month)
1
2
3
4
5
6
7
8
9
10
11
12
Process Characterization (PC)
Method Validation
Process Performance Qualification (PPQ)
Supportive Validation
Stability Study
Preparation of BLA Dossier
GMP Viral Vector Manufacturing：6~8 Weeks
Month
1
2
3
4
5
6
Traditional Timeline
ProBio Timeline
Quality Management System: 90+ Audits with 100% Satisfaction
Follow ICH/FDA/EMA/NMPA/WHO Guidelines
Customer Quality Verification (CQV)
Comply with the GMP Regulations of FDA/EU/NMPA
QA
Quality Requirements
Collection
Quality Requirements
Verification
Personnel
Material
AD & QC
Customer Quality
Requirements
QAA
MSA
Production Preparation
In-Process Control
Product Release
GMP
Project
Shop
Floor
QA
Production
Change from client
Related
QA
Facility &
Equipment