Brochure
GMP Manufacturing Solution for Antibody and Protein Drug
GMP Manufacturing Solution
for Antibody & Protein Drug
Drug substance GMP manufacturing & aseptic fill/finish
from pre-clinical development to commercialization
ProBio has both pilot-scale and commercial-scale GMP manufacturing facilities in China for antibody
and protein drugs. Our diversified facilities satisfy the needs of drug substance GMP manufacturing
and aseptic filling at all scales, from IND to commercialization.
ProBio's overall capacity for drug substance manufacturing has exceeded 20,000 liters. Our upstream
production lines are equipped with single-use bioreactors ranging from 50L to 2,000L, allowing us to
meet the manufacturing needs of various projects.
ProBio boasts two fully automated aseptic filling lines for liquid injection, lyophilized injection, prefilled
syringe, and nasal spray filling. All of the core equipment of the two filling lines is from global top-tier
companies, ensuring the delivery of high-quality products.
150+
190+
3
CMC/CMO projects
GMP batches successfully delivered
PCPV projects
*As of Dec.2025
Quality System
Comply with FDA, EMA, and NMPA GMP Regulations
Client
Audits#
240+ client audits, including US & EU clients
Pass EU QP audits 6 times
Regulatory
1 PAI from BPOM (Indonesian food and
Inspection /QP Audits
drug authority)
• On schedule
CAPA Completion
• Drug Manufacturing Certificate
Certificate
issued by NMPA*
# External Audit History of GenScript ProBio (2019.7-2025.12)
* NMPA refers to China’s National Medical Products Administration
1
Drug Substance GMP Manufacturing
Phase I/II Drug Substance Manufacturing
Fully Single-Use System
•
•
•
Cytiva XDR, Thermo Fisher
HyPerforma single-use bioreactor
AKTA Ready single-use chromatography
system
Mobius single-use filtration system
Zero-Crossover Production Lines
•
•
Unidirectional flow design
Physical segregation of
production lines
Capacity: 2 × 50L, 6 × 200L, 3 × 500L
Phase III & Commercial Drug Substance Manufacturing
200L-2000L Flexible DS Manufacturing
4 × 200L Bioreactors
4 × 500L Bioreactors
•
•
•
•
1 x 1000L Bioreactors
8 × 2000L Bioreactors
2,000L GMP Manufacturing
Price<$100/g*
•
•
Stainless steel buffer preparation
system for materials not in direct
contact with the drug
8,000 L harvest tank supports
scale-out manufacturing mode
such as 2×2000L or 3×2000L per
batch
* DS unit price (a. Fed batch process in 2000L SUB, b. 7g/L, 70% yield, c. annual batch number≥ 20 batches), including FFS and material cost
2
Aseptic Fill/Finish
Top-tier equipment
•
•
•
•
SYNTEGON filling line*
Ross freeze-thaw machine
KYOWAC lyophilizer
SEIDENADER visual inspector
Filling capability for
multiple dosage forms
•
•
•
•
Vial liquid filling
Vial lyophilized powder filling
Pre-filled syringes filling
Nasal spray filling
Pilot Scale FF Line
Commercial Scale FF Line
192 K pcs/batch (2R)
30 K pcs/batch (2R)
All sizes of snap- on
1 ml
2R, 6R, 10R, 20R
0.3-20 ml filling volume)
bottles
(0.3-1 ml filling volume)
(0.3-20 ml filling volume)
* SYNTEGON (former Bosch Packaging Technology)
3
Tech Transfer
Comprehensive and Refined
Technology Transfer Process
Parameter Conversion
Model for Different
Equipment
Comprehensive Risk
Management and
Control
Project approval
Set up gap
analysis team
Assemble project
team
Quality system
Manpower
Facility
Documents
transfer
Documents transfer
Technical
assessment and
compliance
Gap analysis
Environment
Material
assessment
Results of gap
analysis
Transfer proposal
Measurement
Operation
confirmation
Production process
transfer
Cleaning process
transfer
Tech transfer start
Process validation
Report
Analytical process
transfer
Tech transfer
completion
4
ProBio Inc.
Building 9, 311 Pennington Rocky Hill Rd,
Pennington, NJ