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About Cell Therapies

Under the microscope at Cell Therapies

Who are Cell Therapies Pty Ltd?

Cell Therapies is a contract development and manufacturing organization (CDMO) that manufactures and delivers advanced cell-based therapies to the global market. 

Established in 2003, Cell Therapies is one of the most experienced GMP compliant manufacturers of cell therapies, gene therapies, cellular immunotherapies, and regenerative medicine products globally. 

Our facility is co-located with the Peter MacCallum Cancer Centre in Melbourne, Australia, providing access to hospitals, research institutes, and universities to support product development, translation to the clinic, and patient access.  

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GMP manufacturing to meet global regulatory standards

We have a 13-cleanroom GMP facility that meets global regulatory and international organisation for standardisation (ISO) standards benchmarked by the Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S). Our services cover the complete manufacturing process from development to deployment, providing needle-to-needle control with clinical integration.

Our facility holds both commercial supply and clinical trial manufacturing licenses from the Australian Therapeutic Goods Administration (TGA), ensuring the products from our facility meet global regulatory standards such as for U.S. (FDA), Europe (EMA), Japan and other jurisdictions.

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Clean room 6 at Cell Therapies

The Cell Therapies Advantage

We offer significant advantages for cell and gene therapy developers for clinical trial and commercial supply within Australia and worldwide 

Experienced

Over 20 years of experience in GMP manufacturing

Strong quality track record

Strong quality track record with robust quality systems and over 30 inspections

Clinical integration

Full integration into the Australian healthcare system and provide vein-to-vein control for clinical trials

Comprehensive regulatory experience

Global regulatory access to US, EU, Japan, Australia, Korea and other markets

Cell therapy expertise

Extensive GMP cell manufacturing expertise and process development capabilities

Support throughout the development pipeline

Support throughout the clinical development pipeline from first in human clinical trials to commercial supply

Contact the Cell Therapies Team today

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