Flyer
BLA Service
"
ProBioCDMO.com
ProBioCDMO.com
Late Stage Process Development & Commercial
Manufacturing Service
Manufacturing Service
BLA Service
ProBio
01 | BLA Service
*The time of process optimization varies depending on the proj ect. The period of 14 months excludes process optimization.
Completion of
PC
PV
Clinical Sample
Completion
Completion
Manufacturing
PC
PV
Clinical Sample
Completion
Completion
Manufacturing
(5Months) (6 Months> 64 Months*’a
25 L~2,000 L DS
Manufacturing
@ e @ e @ e @@ e @ @@
Manufacturing
@ e @ e @ e @@ e @ @@
|
Clinical Sample
Process
Tech Transfer
Manufacturing
Validation
PAI
Process
Tech Transfer
Manufacturing
Validation
PAI
Material Substitution
PFOCG'SS
:
Parameter Optimization
Characterization
PFOCG'SS
:
Parameter Optimization
Characterization
CMC Documentation
Commercial
Prep for BLA
Manufacturing
Commercial
Prep for BLA
Manufacturing
Clone Change
Process Mode Change
Process Mode Change
**Process
Optimization
Optimization
%
in 4 months
of up to 70%
within one business day
production mode
audits globally
of up to 70%
within one business day
production mode
audits globally
PC completion
Cost reduction
E-mail response
Support scale-out
200+ client
Cost reduction
E-mail response
Support scale-out
200+ client
Fast Process
Powerful Process
Prompt
Cost
Global
Characterization
Optimization
Communication
Savings
Quality System
Powerful Process
Prompt
Cost
Global
Characterization
Optimization
Communication
Savings
Quality System
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facturing. It takes only 14 months** from the initial tech transfer to the completion of pro-
cess validation.
cess validation.
ProBio offers a one-stop BLA solution for late stage process development and commercial
manufacturing. The service includes tech transfer, process optimization, pivotal clinical
sample manufacturing, process characterization (PC), process validation (PV), BLA docu-
mentation prep of the CMC section, pre-approval inspection (PAI), and commercial manu-
manufacturing. The service includes tech transfer, process optimization, pivotal clinical
sample manufacturing, process characterization (PC), process validation (PV), BLA docu-
mentation prep of the CMC section, pre-approval inspection (PAI), and commercial manu-
One-stop solution for process optimization,
process characterization, and process validation
process characterization, and process validation
BLA Readiness in 14 Months
02 | BLA Service
Fill/Finish
26
+
Cost per vial decreased by 60%
«
Fill/Finish cost decreased by 74
%
Release and
48
*
Release and stability cost decreased by
stability studies
B2%
26
+
Cost per vial decreased by 60%
«
Fill/Finish cost decreased by 74
%
Release and
48
*
Release and stability cost decreased by
stability studies
B2%
;
113
service
After optimization
113
service
After optimization
Manufacturing
A project whose fill/finish and DS/DP release
cost of its original process accounted for 50%
of total manufacturing cost.ProBio substituted
high cost materials and optimized the process
parameters.
Material
100
cost of its original process accounted for 50%
of total manufacturing cost.ProBio substituted
high cost materials and optimized the process
parameters.
Material
100
materials, process mode changes, process parameter optimization, and other kinds of customized
process optimizations. Efficient process optimization significantly reduces expense and
improves the product quality of your late-clinical projects.
process optimizations. Efficient process optimization significantly reduces expense and
improves the product quality of your late-clinical projects.
ProBio has extensive experience in process optimization for late-stage clinical projects. Our
experienced process development team is capable of performing substitution of high-cost
experienced process development team is capable of performing substitution of high-cost
Up to 60%
Cost Reduction
Time
8-12 Months
8-12 Months
Clone
Change
Change
Improve process performance and cost efficiency in multiple ways
Powerful Process Optimization
03| BLA Service
*PPQ- Process Performance Qualification
bispecific antibodies.
appropriate for all products, particularly complex molecules such as proteins and asymmetric
or monoclonal /symmetrical bispecific antibodies in liquid formulation. Standard PC is
ProBio offers 2 process characterization services-Fast PC and Standard PC, to meet the
needs of various projects. Fast PC is appropriate for products with accelerated approval pathways
needs of various projects. Fast PC is appropriate for products with accelerated approval pathways
The scope of Fast PC
and validation
DOE
Worst-case condition confirmation
DOE
Worst-case condition confirmation
Scale-down model establishment
Downstream Process
Characterization
Characterization
and validation
DOE
Worst-case condition confirmation
DOE
Worst-case condition confirmation
Scale-down model establishment
Upstream Process
Characterization
Characterization
Data collection & risk assessment
CPP/CQA Evaluation
8-12 Months
4 Months
4 Months
ProBio Fast PC
Industry Standard
Industry Standard
Boost your product with accelerated approval pathways
Advance your project to the PPQ* stage in 4 months
Fast Process Characterization
04 | BLA Service
*NMPA refers to China’s National Medical Products Administration
External Audit History of ProBio (2019.7-2025.12)
issued by NMPA*
Certificate
Drug Manufacturing Certificate
CAPA Completion
e On schedule
I PAI from MFDS (Korean Ministry of Food and Drug Safety)
«
I PAI from BPOM (Indonesian food and drug authority)
I PAI from BPOM (Indonesian food and drug authority)
Regulatory
Inspection /QP Audits
Inspection /QP Audits
Pass EU QP audits 6 times
clients
Audits
Audits
clients
Audits
clients
Client
Client
including US & EU
Client
including US & EU
including US & EU
Nanjing
Zhenjiang
Campus
Campus
140+ client audits,
Zhenjiang
Campus
Campus
140+ client audits,
100+ client audits,
Comply with FDA, EMA, and NMPA GMP Regulations
Quality System Recognized by Global Customers
[015) | BLA Service
scale-out manufacturing modes
suchas 2x2,000 L or 3x2,000 L
per batch.
suchas 2x2,000 L or 3x2,000 L
per batch.
« 8,000 L harvest tank supports
system for materials not in direct
contact with the drug.
contact with the drug.
« Stainless steel buffer preparation
Scale-out Production Mode
« 8x 2,000 L Bioreactors
« 1x1,000L Bioreactors
« 7 x 500 L Bioreactors
» 10 x 200 L Bioreactors
« 2 x50 L Bioreactors
« 5 x 25 L Wave Bioreactors
20,000 L
DS Commercial
Manufacturing Capability
DS Commercial
Manufacturing Capability
25 L~2000 L flexible DS
Manufacturing
Manufacturing
Enables Cost
Savings
Savings
Commercial DS
Manufacturing
Manufacturing
06 | BLA Service
*SYNTEGON (former Bosch Packaging Technology)
Filling Speed
400 pcs/min
400 pcs/min
400 pcs/min
400 pcs/min
Batch Capability
192,000 pcs/batch
192,000 pcs/batch
192,000 pcs/batch
192,000 pcs/batch
Container Size
2R, 6R,10R, 20R
2R, 6R, 10R, 20R
2R, 6R,10R, 20R
2R, 6R, 10R, 20R
Filling volume
0.3-20 ml
0.3-20 ml
0.3-20 ml
0.3-20 ml
SYNTEGON Filling Line
Filling system
SYNTEGON Filling Line
KYOWAC Lyophilizer
Filling system
SYNTEGON Filling Line
KYOWAC Lyophilizer
Liquid filling
Lyophilized Powder Filling
Lyophilized Powder Filling
Zhenjiang FF Line
Filling Speed
125 pcs/min
125 pcs/min
120 pcs/min
/
125 pcs/min
125 pcs/min
120 pcs/min
/
Batch Capability
30,000 pcs/batch
22,200 pcs/batch
28,880 pcs/batch
6,000 pcs/batch
30,000 pcs/batch
22,200 pcs/batch
28,880 pcs/batch
6,000 pcs/batch
Container Size
2R, 6R, 10R, 20R
2R, 6R, 10R, 20R
1ml
All sizes of snap-on
bottles
2R, 6R, 10R, 20R
2R, 6R, 10R, 20R
1ml
All sizes of snap-on
bottles
Filling volume
0.3-20 ml
0.3-20 ml
0.3-1ml
0.3-20 ml
0.3-20 ml
0.3-20 ml
0.3-1ml
0.3-20 ml
Filling system
SYNTEGON
SYNTEGON Filling Line
ORAB:s filling line from
Flexicon Filling pump
Filling Line
TOFFLON Lyophilizer
SYNTEGON
Aptar sealer
SYNTEGON
SYNTEGON Filling Line
ORAB:s filling line from
Flexicon Filling pump
Filling Line
TOFFLON Lyophilizer
SYNTEGON
Aptar sealer
Nanjing FF Line e
Lyophilized
-
i
alhe
Liquid Filling
Powder Filling
Syringe Filling
Nasal Spray Filling
Lyophilized
-
i
alhe
Liquid Filling
Powder Filling
Syringe Filling
Nasal Spray Filling
Liquid Injection/Lyophilized Injection/Prefilled Syringe/Nasal Spray
Commercial Fill/Finish Delivers Premium Products
+1-732-885-9188 (US)
ProBioCDMO.com
ProBioCDMO.com
Building 9, 311 Pennington Rocky Hill Rd, Pennington, NJ
ProBio Inc.
ProBio