Advanced manufacturing process for the production of individualised cell therapies

Cell Medica, develops, manufactures and provides cellular immunotherapy products for the treatment of infectious disease and cancer. Cell Medica Ltd collaborated with eXmoor Pharma Concepts Ltd and University College London (UCL) on this project, with the aim of the development of a scaled-up manufacturing process for production of virus specific T cell therapies. Cell Medica’s lead product is Cytovir CMV, a T cell therapy targeting Cytomegalovirus (CMV) in patients who have undergone bone marrow transplants or allogeneic haematopoietic stem cell transplants (allo-HSCT).
The project developed new cell processing methods and achieved step change improvements in the key production parameters of cost, time, quality and flexibility. A modular closed cell processing system was developed and manufacturing costs savings were identified.
An advanced manufacturing system was designed and successfully prototyped. A transition plan and supporting documentation is in place to enable Cell Medica to operate within a facility that will support production targets of 5,000+ cell products per annum.
eXmoor Pharma Concepts have gained insight and understanding into individualised cellular therapy manufacturing issues and this will allow their support of the development of processes by other groups in the UK and hence the consulting activities of eXmoor.
UCL were able evaluate selection of target cells from mobilised aphaeresis, evaluate alternative cell selection targets and develop identity and potency assays, forming a significant part of the UCL researcher’s PhD.