On February 12, 2021 Novartis reported it has received approval from the Therapeutic Goods Administration (TGA) for Cell Therapies to manufacture and supply its CAR-T therapies commercially for eligible patients in Australia (Press release, Novartis, FEB 12, 2021, View Source [SID1234575019]). The Cell Therapies manufacturing facility in the Peter MacCallum Cancer Center in Melbourne is the first and only approved commercial manufacturing site for CAR-T cell therapies in Australia.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
As a pioneer in individualized medicine, Novartis is committed to reimagining cancer care in the emerging field of CAR-T therapies. We are determined to bring these transformative therapies to the maximum number of patients with difficult-to-treat cancers and limited treatment options. We are proud to have the largest geographical CAR-T manufacturing network in the world, which makes our therapies accessible to healthcare practitioners and patients across the globe. Cell Therapies, a world-leading manufacturing facility, adds their experience to our leadership in pioneering research, development and supply of cell and gene therapies. International collaborations such as these are critical in accelerating advancements in areas of great medical need.
Steffen Lang, Global Head of Novartis Technical Operations
The CAR-T manufacturing network of Novartis comprises of seven facilities across four continents. This includes commercial and clinical trial manufacturing now ongoing at Novartis-owned facilities in Stein, Switzerland, Les Ulis, France and Morris Plains, New Jersey, USA, as well as at the contract manufacturing sites at Fraunhofer-Institut for Cell Therapy and Immunology (Fraunhofer-Institut für Zelltherapie und Immunologie) facility in Leipzig, Germany, FBRI in Kobe, Japan, and now Cell Therapies in Australia. Manufacturing at Cellular Biomedicine Group in China is forthcoming. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain.
To date, more than 100 patients in Australia have now been treated with Novartis CAR-T treatment across clinical trials and commercially available therapy. Local manufacturing means patients’ cells can stay in Australia without the need to ship them overseas, generating greater efficiencies and an expectation of quicker timelines tor eligible patients.