---
name: Cell Therapies
slug: celltherapies
site: cdmo
website_domain: celltherapies.com
summary: GMP contract manufacturer of autologous and allogeneic cell therapies from first-in-human trials through commercial supply, with two decades of experience in CAR-T, mesenchymal stromal cells, TILs, and pluripotent stem cell derivatives. Offers end-to-end cold chain management, process development, quality control analytics, and regulatory consulting across Australia and Asia-Pacific. Headquartered in Melbourne, Australia.
tagline: GMP cell therapy manufacturing from first-in-human to commercial supply, with two decades of CAR-T and allogeneic expertise.
founded_year: 
employee_count_band: 
employee_count_label: 
parent_name: 
parent_slug: 
hq_country: AU
tier2_domain_verified: false
updated_at: 2026-06-28T07:01:04.795Z
services_count: 9
modalities_count: 2
indications_count: 1
locations_count: 1
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Cell Therapies

GMP cell therapy manufacturing from first-in-human to commercial supply, with two decades of CAR-T and allogeneic expertise.

Listed on cdmo.directory.

## Summary

GMP contract manufacturer of autologous and allogeneic cell therapies from first-in-human trials through commercial supply, with two decades of experience in CAR-T, mesenchymal stromal cells, TILs, and pluripotent stem cell derivatives. Offers end-to-end cold chain management, process development, quality control analytics, and regulatory consulting across Australia and Asia-Pacific. Headquartered in Melbourne, Australia.

## At a glance

- HQ country: AU

## Services

- Cell Therapy Manufacturing
- Autologous Cell Therapy Manufacturing
- Allogeneic Cell Therapy Manufacturing
- Technology Transfer
- Process Development
- CMC Analytical Development
- Quality Control Testing
- Cold-Chain Storage & Logistics
- CMC Regulatory Submission Support

## Modalities

- Cell Therapy
- Gene Therapy

## Indications

- Oncology

## Locations

- Headquarters / Manufacturing & Development, Melbourne, Victoria, Australia

## Certifications

- TGA; Identifier: TGA-licensed; Source: https://celltherapies.com/
- FDA; Identifier: FDA inspection-ready; Source: https://celltherapies.com/
- PMDA; Identifier: PMDA inspection-ready; Source: https://celltherapies.com/
- EMA; Identifier: EMA inspection-ready; Source: https://celltherapies.com/

## Long description

## Overview

Cell Therapies is a GMP contract manufacturer specializing in complex cell-based therapies, with over two decades of experience spanning autologous and allogeneic modalities. The company supports programs from translational first-in-human clinical studies through late-phase trials and commercial supply.

## Manufacturing & Process Development

- **Cell Therapy Manufacturing:** Licensed GMP manufacturing for autologous and allogeneic cell therapy products, including CAR-T cells, mesenchymal stromal cells (MSCs), tumor-infiltrating lymphocytes (TILs), and human pluripotent stem cells and derivatives.
- **Technology Transfer:** Phase-appropriate, risk-based framework across six gated stages (technical feasibility, knowledge capture, process implementation). Over 10 successful technology transfers in the last 4 years, including commercial CAR-T programs.
- **Process Development:** Dedicated PC2/BSL2 development laboratory with expertise in closed systems, automation, and rapid scale-up for early-stage clinical products; cost reduction and robustness optimization for late-stage and commercial programs.

## Cold Chain & Logistics

- Validated cryopreservation using vapor-phase liquid nitrogen systems for apheresis collections, in-process intermediates, and final products.
- GMP-compliant labeling, storage, and chain-of-custody documentation.
- Established logistics partnerships supporting cryo-transport and direct-to-patient delivery across Australia, Asia-Pacific, and global clinical trial networks.

## Quality Control & Analytics

- TGA-licensed flow cytometry (21 CFR Part 11 compliant).
- ddPCR and qPCR-based assays, ELISA, and cell-based potency assays.
- Rapid sterility (BacT/ALERT), endotoxin, and mycoplasma testing.
- Stability testing with cryopreservation protocols.
- Assay development, validation, and compliance infrastructure for early- and late-stage programs.

## Regulatory & Consulting Services

- CMC road-mapping and regulatory gap assessments.
- FACT accreditation and GMP readiness support.
- Quality management consulting (QbD, risk assessments).
- Facility build-vs-buy feasibility for early-stage innovators.
- Asia-Pacific clinical feasibility assessment and country selection.
- Regulatory agency meeting support and submission strategy.
- Quality Consultation as a Service (QCaaS) with ongoing SME access.
- Quality as a Service (QaaS): fit-for-purpose QMS solutions for biotech companies, hospitals, and academic groups.

## Regulatory Recognition

Quality systems have passed reviews by TGA, FDA, PMDA, and EMA. QMS implemented in hospitals to support stem cell collections, transplants, and cell and gene therapy delivery.

_Profile last updated: 2026-06-28T07:01:04.795Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.