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● GMP • ISO 13485 • FDA Registered Lab

Clinical-grade cell culture for future medicine.

From biopsy to bedside: we isolate, expand, characterize and bank human cells under strict GMP conditions. MSC, iPSC, T-cells, organoids — scalable, traceable, clinic-ready.

0Clinical batches / year
0% Viability avg.
0Cell types mastered
0Years GMP experience
GMP cell culture laboratory cleanroom

Live Cleanroom B — Passage 4 MSC expansion

Temperature 37.0°C • CO₂ 5.0% • Confluence 78% • Mycoplasma NEG

LIVE QC MONITORING • PARTICLES ISO 5 • 24/7
MSC THERAPY ✦ IPSC REPROGRAMMING ✦ 3D ORGANOIDS ✦ CAR-T EXPANSION ✦ EXOSOMES ✦ CRYOBANKING ✦ GMP MANUFACTURING ✦ MSC THERAPY ✦ IPSC REPROGRAMMING ✦ 3D ORGANOIDS ✦ CAR-T EXPANSION ✦ EXOSOMES ✦ CRYOBANKING ✦ 
01 — About us

Not just a lab.
A translational engine.

ClinicalCellCulture was founded by cell biologists and clinicians to close the gap between discovery and therapy. We operate BSL-2 and GMP suites with full traceability from donor consent to final vial.

Scientist working with cell culture in biosafety cabinet
✓
Certified GMP Facility
Audited 2025 • Sterility, endotoxin, karyotype, STR for every lot
Our mission

Make every cell count — safe, potent, reproducible.

We support hospitals, IVF clinics, orthopedic centers, dermatology networks and biotech startups. Whether you need autologous fibroblasts for a single patient or 50L allogeneic MSC batch for a Phase II trial, we deliver with COA, batch record and regulatory dossier.

100%
Traceability chain of custody
0
Contamination events in 2024-2025
2014 — Founded
Primary fibroblast & keratinocyte lab for burn centers.
2019 — GMP expansion
4 cleanrooms, iPSC reprogramming, MSC master banks.
2024 — Translational hub
Organoids, exosomes, CAR-T pilot, 40+ clinical partners.
02 — Services

Full-cycle cell manufacturing.

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Primary cell isolationIsolation

Primary Cell Isolation

Adipose MSC, bone marrow, umbilical cord, dermal fibroblasts, PBMCs. Enzymatic + explant protocols with donor screening.

Microscope cell expansionExpansion

GMP Expansion & iPSC

Xeno-free, chemically defined media. iPSC reprogramming (Sendai, episomal), directed differentiation, single-cell cloning.

3D organoids bioreactor3D Models

Organoids & Bioprinting

Intestinal, cerebral, hepatic, tumoroids for drug screening. Bioreactors up to 10L, microcarriers, hollow-fiber systems.

Cryobanking vialsBanking

Master Cell Banking

GMP cryopreservation in vapor-phase LN2, automated inventory, stability program, global dry-shipper logistics.

Quality control testingQC / QA

QC & Characterization

Flow cytometry (ISCT panel), karyotype, STR, sterility, mycoplasma, endotoxin, potency assays, NGS.

Regulatory supportClinical

Regulatory & Logistics

IND/ATMP dossier support, batch records, COA, QP release, hospital delivery in validated 2-8°C / -150°C chain.

03 — How it works

From sample to therapy in 4 steps.

STEP 01

Intake & Screening

Donor consent, infectious screening, sample kit shipped overnight. Barcoded chain-of-custody.

STEP 02

Culture & Expansion

Seeding in ISO 5, daily confluence imaging, media exchange, passage tracking in LIMS.

STEP 03

QC Release

14-day sterility, flow, viability >90%, potency. Independent QA review + COA.

STEP 04

Delivery / Banking

Fresh infusion or cryobanked vials. Courier with temp logger + clinical report.

Cleanroom bioprocessing Cell culture incubators
04 — Applications

Where our cells work.

Orthopedics, wound healing, aesthetics, immunotherapy, toxicology and disease modeling.

🦴 Ortho & Sports

Autologous MSC for cartilage, tendon, non-union fractures. 2-week turnaround, ultrasound-guided injection support.

🧬 Immuno-Oncology

T-cell, NK, CAR-T expansion, tumoroids for personalized chemo-sensitivity testing in 10 days.

✨ Skin & Aesthetics

Fibroblasts, PRP + exosomes, melanocytes. GMP-grade for clinics, private label banking.

05 — Lab Journal

Latest news & protocols.

Methods, QC data, regulatory updates and case studies from our scientists.

No news yet — check back soon.

We publish QC-validated protocols every month. Contact us for the latest SOPs.

06 — FAQ

Questions? Cultured answers.

Turnaround, pricing, shipping and compliance — transparent.

Lab quality team
How long does MSC expansion take?

Typically 14-21 days for 50-200M cells from adipose or cord tissue, including QC. Rush 10-day service available for autologous cases.

Do you work with clinics outside the US?

Yes. We ship cryopreserved vials globally in dry shippers (-150°C for 10 days) with customs and import permits handled.

What QC is included?

Viability, sterility, mycoplasma, endotoxin, flow panel (CD73/CD90/CD105), STR, karyotype on master banks, plus COA.

Can you help with FDA / EMA filing?

Absolutely. We provide batch records, validation reports, stability data and CMC sections for IND/IMPD and hospital exemption.

How much does it cost?

Autologous projects from $2,900. Allogeneic GMP batches quoted per scope. Banking $49/month per box.

● READY FOR CULTURE?

Let's grow your next therapy together.

Send tissue, biopsy or PBMCs — get clinic-ready cells with full dossier. Free 30-min scientific consult.

Scientist holding cell culture flask