Novel biotherapies are often driven by industrial innovations but require clinical and academic medical collaborations. In the evolving fields of biotherapies and transfusion medicine, there is an ever-increasing demand for high quality products as raw materials for further manufacturing. An important challenge for apheresis centers is management of distinct industrial protocol details, including heterogenous operational parameters that may not always conform to routine clinical practices. Factors such adequate staffing, budget, equipment, space and shipping and delivering logistics pose formidable challenges to blood centers and hospitals and threaten the ability of these organizations to meet demand. This session will discuss real experiences from professionals in the field and will propose creative approaches in overcoming those challenges, including the business agreements as well as the regulatory framework involving these type of products. We will engage the audience to map out the goals of their own apheresis production pipelines by applying principles of process improvement that identify and then leverage their operational constraints, with concrete examples. The speakers will also share practical tips regarding the establishment of business agreements that include negotiations between the sponsor(s) and the institution.
Describe the process of setting up and managing an apheresis center that can provide high quality products for cellular therapy, particularly in the setting of clinical trials using experimental therapies.
Discuss how the theory of constraints can be applied to your apheresis center to identify and manage bottlenecks
Review the regulatory framework around cellular therapy products
Recommend the minimal elements of business agreements between institutions and the sponsors or manufacturing biopharma companies that need to be present before signatures are obtained.