Knowing thyself: an audit of cell therapy manufacturing in Australia and New Zealand

Abstract

Background & Aim We conducted a survey to assess cell therapy manufacturing capacity in Australia and New Zealand. We examined the number and types of cell therapy manufacturing facilities; the number of projects, parallel processes and clinical trials; the types of products; and manufacturing and quality staffing levels. We identified participant cell therapy manufacturing facilities by contacting individuals working in the field of cell therapy in Australia and New Zealand and inviting submissions on a one per cell manufacturing facility basis. Methods, Results & Conclusion The overall response rate was 59% (23 of 38 eligible facilities). Of the 23 responding facilities, 21 are in Australia and 2 are in New Zealand. Eighteen are run by public organisations and five by private organisations and a diverse range of accreditations were represented. There were 43 GMP laboratories across 14 of 22 facilities that reported on this parameter and approximately 4.6 manufacturing staff and 1.7 quality staff per facility. Products included hematopoietic progenitor cells, mononuclear cells, T-cells, peripheral blood mononuclear cells, CD34+ cells, mesenchymal stem cells and chimeric antigen receptor T-cells, therapeutic T-cell subsets, cell banks, autologous serum eye drops, keratinocytes, human amnion epithelial cells, pancreatic islets, dendritic cells and chondrocytes. Research interests were processing and storage optimization; the effect of methodologies on engraftment; gene and cell therapy; the biology of manufactured cell types; cell tracking and imaging; cell culture platforms; bioscaffolds; 3-D bioprinting; transplantation and the diseases treated. Reported collaborations included within Australia and with groups in Basel, Busan, Boston, Cambridge MA, Hong Kong, Los Angeles, Montreal, Nagoya, New York, Philadelphia, Stockholm and Toronto. Other national manufacturing-relevant assets are the Centre of Research Excellence in MedTech in New Zealand, the Cooperative Research Centre for Cell Therapy Manufacturing in Australia, the Australian National Health and Medical Research Council Clinical Trials Centre and Advanced Health Research and Translation Centres and Therapeutic Innovation Australia. Australian and New Zealand provide a platform for cell therapy manufacturing, infrastructure and capacity building. These form the foundation to enable both countries to meet the growing need for cell and gene therapy and regenerative medicine in our region.