Mobility of nurse for development of apheresis

Purpose and goal

The aim was to improve the apheresis procedure for collection of Starting Material for Cell Therapy Products. The Project resulted in that CASH has validated and implemented a new method for apheresis for harvest of both Stem Cells and therapeutic cells. Know-how about collection of Starting Material for Advanced Therapy Medicinal Products (ATMP) has increased and contributed to a quality driven process optimization. A better defined Starting Material is the key to a better trial drug. Project goals have been met and data created continued, innovative collaboration for CASH and CPNP.

Expected results and effects

The Project has identified new key parameters for apheresis components, updated protocol and new equipment has been implemented based on obtained knowledge. This has contributed to increased awareness regarding Quality Assurance and GMP for the apheresis process which are important for collection of Starting Material for ATMPs. It has also allowed for patients to get treatment with individually selected populations of therapeutic cells and that CASH can reach a new market for apheresis products.

Planned approach and implementation

Systematic literature search of data showed no similar projects. A further mapping of apheresis procedure through meetings with researchers/industry, participation in congresses and auscultation with CPNP has led to new knowledge. This in combination with apheresis data compiled from CASH and from clinical batches made by CPNP indicates that a defined apheresis method and set specification of target cells for cell therapies results in better cell harvest. Nurses working with apheresis and having knowledge of both GCP and GMP will be important for the development of improved ATMPs.