Brochure
IND-Enabling CMC Strategy for Biologics
Antibody & Protein Drug
IND-enabling CMC Service
Developing Complex Molecules Easily
ProBio, leveraging our expertise in process development and manufacturing scale flexibility, provides
integrated solutions across a variety of modalities and applications to get your biologics to the clinic
quickly and reliably.
70+ 150+ 280+
IND clearances
CMC/CMO projects
Commercial cell line projects
4
190+
9
Biologics or medical
devices launched
GMP batches
ProBio supports partners
in license-out projects
(including 2 projects with buyers
from MNCs)
successfully delivered
* As of Dec. 2024
Service Highlights
4 months from DNA to Tox DS for mAb &
symmetric bsAb
Fast and Guaranteed
Delivery
~50% projects delivered are proteins & bsAb
40+ IND clearances of complex molecules
Experience of multiple complex modalities
Developing Complex
Molecules Easily
Tailored CMC solutions
for emerging AXC modalities
Light CMC solutions
for antibody & protein for cell therapy
Small manufacturing scale
for GMP materials
Customized Solutions for
Emerging Modalities and
Niche Applications
Strong technical support
by the project leader team
Efficient communication
by the project manager team
Dual-role Driven
Project Execution and
Management
* Mar.2026
1
Fast and Guaranteed Delivery
ExpressCMC™: Industry-leading Development Speed
Get Tox Batch Ready in 4 Months and GMP DP in 9 Months
Tox DS (PCB) ready
Empowered by proprietary ProMax vector (US Application# 63/652,263)
BSAB2 clone stability
MAB2 clone stability
MAB1 clone stability
PDL0
PDL60
PDL0
8
6
4
2
0
6
4
2
0
10
PDL0
PDL0
PDL0 PDL60
PDL60
PDL60
PDL60
PDL0
PDL0
PDL60
PDL0
PDL60
8
PDL60
PDL0
PDL60
6
4
2
0
clone98
clone290
clone335
Clone84
Clone95
Clone311
Clone30
Clone183
Clone223
ExpressCMC™ is applicable for:
High Titer Performance of ProMax vector：
mAb average titer:~6g/L
bsAb average titer: ~9g/L
IgG1 & IgG4 mAb and symmetric bsAb
Liquid injection
DP concentration ≤ 50mg/ml (mAb)
DP concentration ≤ 30mg/ml (symmetric bsAb)
2
Developing Complex Molecules Easily
Proven experience with dozens of native proteins, fusion proteins, symmetric
bsAbs, and asymmetric bsAbs projects
Deliciated platform processes for Proteins & Bispecifics
1
200+ ProBox process solutions enable the development of new projects
2
Analytical method development to identify mismatch
Bioassay development based on bifunctional/multifunctional MOA
3
Case Study: Trispecific Antibody (IND cleared)
Titer
Abnormal Glycan
Purity
Bioassay
Media screening and
amino acid supplement
to improve the titer by
62%
Mn2+ additive lowered
Man-5 by 54%
Purity improved from
84.7% to 98.6%,
meeting the requirement
of IND filing
Strong bioassay
development to solve
the multi targets
challenge
3
Customized Solutions for Emerging Modalities and Niche
Applications
Emerging AXC Modalities
Flexible development
Antibody-arming cell therapy
Ab nucleotide conjugate
Ab chelator conjugate
strategy & small
manufacturing scale for
Antibody & Protein for Cell Therapy
Light CMC strategy and
GMP grade & small
Custom cytokine & antibody for cell amplification,
activation and separation of cell therapy
manufacturing scale for
GMP Materials
Custom antibody for medical devices, etc.
Dual-role Driven Project Execution and Management
At ProBio, our project leader team and project manager team collaborate to ensure the smooth
delivery of your project.
Strong technical support
by the project leader team
Efficient communication
by the project manager team
Director-level positions and above
10+ years of industry experience
Technical lead
Weekly progress update
Biweekly teleconference
Respond to emails within one business day
Report risks & important issues within
24h to customers
4
ProBio Inc.
Building 9, 311 Pennington Rocky Hill Rd,
Pennington, NJ