When do I (not) release cellular products

摘要: Harvest, production, storage and release of cellular products are regulated by international guidelines like the EU 2004/23/EC or 2006/17/EC. In addition, worldwide effective exist with FACT-JACIE standards. As such as haematopoietic progenitor cells (HPC) usually applied to critically ill patients requirements for must be well defined high. The determination criteria requires a prior definition specifications parameters product. Such question product out specification will addressed here exemplarily autologous allogeneic HPC grafts. The harvest preceded an examination healthy donor in case transplantation patient. Apart from medical history clinical condition donor, results testing infectious disease markers (IDM) (HCV, HBV, HIV1,2 syphilis at minimum) decisive judgment on donor’s eligibility donation. even positive test IDM do not necessarily exclude After processing product, records complete content active pharmaceutical ingredient, i.e. CD34+ grafts, possible contaminants CD3+ setting tumour setting, relevant need specified. For cells, minimum amount 2 × 106 cells/kg body weight 4 × 106 cells/kg grafts is required. This may sometimes only achieved more than one harvest. Regarding quality viability optional analysis clonogenic growth has evaluated. measured especially after manipulations cryopreservation selection depletion procedures. microbial contaminations, potential contaminations aerobe anaerobe bacteria fungi products, have detected. Cellular undergoing incubation steps examined mycoplasma viruses addition. Furthermore, activation require examinations regarding functionality, genomic stability malignant transformation cultivated cells. The final decision being should guided consideration that benefits outweigh risks recipient when administering type other lymphocyte infusions, its importance given situation patient, documented urgent need, influence release.