Cell Therapies is a contract development and manufacturing organization that manufactures and deploys 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 services cover the complete manufacturing process from program development, clinical trial design and deployment, to commercial supply.
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.
From translation to commercialization, across a wide range of cell types, we have the capabilities to deliver life-changing treatments to global markets.
We can develop and manage your apheresis collection protocol, site selection, as well as cryostorage and distribution
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.
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.
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.
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.
We offer significant advantages for cell and gene therapy developers for clinical trial and commercial supply within Australia and worldwide
We have over 18 years’ experience in GMP cell manufacturing, including CAR-T cell therapy manufacturing since 2006
We have robust quality systems, have undergone over 25 TGA inspections, and hold a current GMP manufacturing license
We are wholly integrated into the Australian healthcare system and provide needle-to-needle control for clinical trials and manufacturing process development
We have global regulatory expertise with access to US, EU, Japanese, Australian, Korean, Chinese and other Asian markets
We invest heavily in our personnel and have extensive cell processing expertise and process development capabilities
Our services support programs from translation (first in human) through to clinical trial and commercial supply
To reach out to our expert team, enter your details below and we will contact you to arrange a call at a time that suits you.
