About Cell Therapies

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

Under the microscope at Cell Therapies

Clinical trial and commercial supply of cell and gene therapies

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 services cover the complete manufacturing process from program development, clinical trial design and deployment, to commercial supply.

GMP manufacturing to meet global regulatory standards

We have a 10-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.

Clean room 6 at Cell Therapies

Global leaders in cell and gene therapy

From translation to commercialization, across a wide range of cell types, we have the capabilities to deliver life-changing treatments to global markets.

Apheresis Management

We can develop and manage your apheresis collection protocol, site selection, as well as cryostorage and distribution

Contract Manufacturing

Our technology transfers are rapid and we have extensive experience to develop and optimize your GMP manufacturing process for both clinical trial and commercial supply.

Clinical Trial Support

We have vast experience in the GMP manufacture of cell and gene therapies for clinical trial programs. We can manage product storage, supply chain logistics, and deployment and distribution across Australia and the globe.

Consulting and Advisory

Come to us for expertise on GMP process development, regulatory requirements across PIC/S compliant jurisdictions, and cryogenic storage and deployment programs of cell and gene therapies worldwide.

Cell therapy culture

Needle-to-needle solutions for cell and gene therapies

Our facility is located at the heart of the Melbourne Biomedical Precinct. We have access to hospitals, research institutes, and universities to support product development, translation to the clinic, and patient access. Working closely with our clinical and research collaborators at the Peter MacCallum Cancer Centre, we provide clients with needle-to-needle control with clinical integration for cell and gene therapies.

We are a member of the Melbourne Biomedical Precinct and are supported by Therapeutic Innovation Australia, an NCRIS network member.

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

We have over 18 years’ experience in GMP cell manufacturing, including CAR-T cell therapy manufacturing since 2006

Strong quality track record

We have robust quality systems, have undergone over 25 TGA inspections, and hold a current GMP manufacturing license

Clinical integration

We are wholly integrated into the Australian healthcare system and provide needle-to-needle control for clinical trials and manufacturing process development

Comprehensive regulatory experience

We have global regulatory expertise with access to US, EU, Japanese, Australian, Korean, Chinese and other Asian markets

Cell therapy expertise

We invest heavily in our personnel and have extensive cell processing expertise and process development capabilities

Support throughout the development pipeline

Our services support programs from translation (first in human) through to clinical trial and commercial supply

Contact the Cell Therapies Team today

Call Cell Therapies on +61 3 8559 7310 to talk to our expert team or enter your details below and we will contact you to arrange a call at a time that suits you.


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