Contract Manufacturing for the Future of Regenerative Medicine.

GMP-grade cell therapies, exosomes, and secretomes — designed, manufactured, and deployed from Latin America to the world.

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A CDMO Engineered for Translational Success.

We ITC-CDMO

We are a Latin American contract development and manufacturing organization born from over 16 years of experience in regenerative medicine and biologics. As a spin-off of ITC (Instituto de Terapias Celulares), we offer full-service GMP solutions to help biotech companies, innovation hubs, and specialty clinics scale their therapies — from early-stage R&D to clinical deployment.

We base our success on our key points:
– Full GMP-compliant infrastructure
– Commercialization experience in live cell-based products
– Real-world deployment through a clinical network
– Scalable support from lab prototype to manufacturing

More than a manufacturer — we are your long-term translational partner.
Juan P. AguilarCEO of ITC-CDMO



Integrated CDMO Capabilities.

Our Services

  • Mesenchymal Stem/Stromal Cells (MSCs)| Natural Killer Cells (NKs)| Dendritic Cells|T Cells| Regulatory T Cells (Tregs)
  • Exosome Production – Ultracentrifugation and scalable platforms | NTA, protein QC | Endotoxin-free
  • Secretome Development – Bioactive formulations for skin, hair, and aesthetics | Cosmeceutical-grade
  • Clinical Integration – Access to clinical partners for early-stage use and post-market feedback
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Built for Scale…

GMP Manufacture

  • ISO 5 and ISO 7 cleanrooms
  • Validated biological sourcing: adipose tissue, bone marrow, cord, amnion
  • Electronic batch records & traceability systems
  • In-house QC: endotoxin testing, sterility, cytometry
  • Pilot manufacturing for clinical-grade scale-up
  • Full cleanroom workflows for cell, exosome, and secretome manufacturing.
  • Pilot Plant & Scale-Up – From small batch to GMP production | Process validation & batch records
  • Operations under GMP principles and in alignment with ISO 13485, NOM-241, NOM-059, and 21 CFR 1271, integrating verification and validation processes in accordance with international quality standards.
Company Capabilities



Your Ideal CDMO if You Are…

Who We Serve

  • Biotech Startups
  • From preclinical to GMP under one roof
  • Cosmetic Companies
  • White-label secretomes with clinical data
  • Hospital Networks
  • Turnkey biologics for integration in protocols
  • Global CDMOs/CMOs
  • Nearshore outsourcing with competitive costs
  • Investors & VCs
  • De-risked CDMO platform with real deployments
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Decades of Experience, Backed by Real GMP Execution

GMP-Grade Cell Therapies, Exosomes, and Secretomes

Our GMP operations are built upon more than 16 years of real-world experience in developing, manufacturing, and delivering cell-based therapies across multiple medical fields.

As a contract development and manufacturing partner, ITC-CDMO has supported numerous projects from the R&D phase through GMP-compliant production and into clinical deployment — always under the strictest quality and regulatory frameworks.

“We don’t just offer capacity — we offer proven, compliant execution.”

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Integrated CDMO Capabilities

Committed to Quality

Cell Therapy Manufacturing

MSCs, Muse Cells, NK, Tregs | Xeno-free culture | Injectable formats | 2D/3D expansion.

Exosome Production

Ultracentrifugation and scalable platforms | NTA, protein QC | Endotoxin-free.

Secretome Development

Bioactive formulations for skin, hair, and aesthetics | Cosmeceutical-grade.

Pilot Plant & Scale-Up

From small batch to GMP production | Process validation & batch records.

Regulatory & Quality Consulting.

ISO 13485 | NOM-241 | 21 CFR 1271 | Document support

Clinical Integration.

Access to clinical partners for early-stage use and post-market feedback.

Our INFRASTRUCTURE

GMP Manufacturing, Built for Scale.

– ISO 5 and ISO 7 cleanrooms.

– Validated biological sourcing: adipose tissue, bone marrow, cord, amnion.

– Electronic batch records & traceability systems.

– In-house QC: endotoxin testing, sterility, cytometry.

More than a manufacturer — we are your long-term translational partner

PATNERSHIP

Let’s Collaborate — Start Your CDMO Project with ITC-CDMO…

We don’t just offer capacity — we offer proven, compliant execution.

Request Project Consultation

We are The Contract Development & Manufacturing of Advanced Therapies, Engineered for Translational Success

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