01 / Domain
Cell Therapy
Contract manufacturing of human stem and immune cells under closed bioreactor systems.
Stem Cells
- —MSC
- —iPSC
- —MUSE
- —VSEL
Immune Cells
- —NK
- —CAR-NK
- —T
- —Treg
- —Dendritic
Regenerative Bioprocessing — Engineered to Scale
Contract Manufacturing & Research
StemRegenex Bio provides contract manufacturing of human stem cells, immune cells, secretome, extracellular vesicles, and viral vector systems — produced under cGTP and cGMP-aligned standards — for IND sponsors, biotech developers, and research institutions.
Type II FDA Master Files·ISO 9001-aligned·Trusted by 25+ countries
Viability
98.4%
Characterization
Flow / qPCR
Capabilities
Four domains. One stack.
02 / Domain
Viral Vector Systems
Process development and manufacturing of vector and delivery systems for further manufacturing use.
Vectors
- —Minicircle
- —AAV9
- —LNPs
- —Plasmids
03 / Domain
Secretome / EVs
MISEV-aligned production and characterization of cell-source-specific extracellular vesicles.
EV Sources
- —MSC
- —NK
- —MUSE
- —VSEL
- —Chondrocyte
- —Platelet
04 / Domain
Tissue Engineering
Lyophilised wound grafts and matched scaffold systems for regenerative repair research.
Capabilities
- —Lyophilised Wound Grafts
- —Scaffold-Matched Biologics
Path to Commercialization
From research bench to registered trial — without re-developing.
01 /
Research & Optimization
High-quality raw materials with built-in protocols that make it easy to establish MSCs in new programs.
02 /
Product & Process Development
Robust hMSC systems that let you focus on your final development goals instead of rebuilding processes.
03 /
Tech Transfer & Manufacturing
Closed, scalable processes transferred into cGMP-aligned manufacturing around your IND timeline.
Why StemRegenex Bio
Science-led manufacturing.
01
20+ Years Research Experience
Two decades of stem cell biology and clinical immunology translated into manufacturing protocols that preserve identity, potency, and safety.
02
3D Bioreactor Technology
Proprietary high-density expansion under physiologically relevant conditions — superior yields and lower cost per cell than 2D flask expansion.
03
Minimal Manipulation
Processes designed around 21 CFR 1271 minimal-manipulation principles — preserving native phenotype and reducing regulatory burden.
04
FDA Compliance & Safety
21 CFR Part 1271 & 211 aligned manufacturing with IND-enabling batch records, SOPs, CoA, sterility, mycoplasma, endotoxin, and karyotype release.
0+
Tissue Sources of hMSCs
0%
Lot-Traceable Donor Screening
0B+
Cells per Order at Peak Scale
0hrs
Typical Quote Turnaround
Technology
From Contract Research to cGMP Manufacturing.
A single, accountable pipeline — preclinical development, process development, cGMP manufacturing, and clinical trial readiness. Built on 3D bioreactor technology, minimal manipulation, and FDA-compliant systems.
- 01Preclinical Dev
- 02Process Dev
- 03cGMP Manufacturing
- 04Clinical Trial Ready
3D
Bioreactor technology
Min.
Manipulation (21 CFR 1271)
FDA
Compliant systems
cGMP
Translation-ready manufacturing
Engagement Process
From scoping call to tech transfer.
01
Scoping Call
Map your indication, scale, timeline, and regulatory pathway.
Day 1
02
Statement of Work
Fixed-scope SOW with milestones and flat-fee budget within 5 days.
Week 1
03
Process Development
Lab-validated workflow on your matched cell and media system with data check-ins.
Weeks 2–8
04
Tech Transfer
Closed, scalable process with full documentation ready for your CDMO.
Weeks 9–12
Let's talk
Have a regenerative program in development?
let's talk.
— Matched Systems— cGMP-Ready Translation— Operator-Led Team
Schedule a Scoping Call