Challenges of human platelet lysate production: Results of an International Survey of the ISBT Working Party on Cellular Therapies.

BACKGROUND AND

OBJECTIVES

Global demand is rising for human platelet lysate (HPL) in the manufacture of cell-based medicinal products, but platelet resources are scarce. As protocols for the production process and quality testing are heterogeneous, the Working Party on Cellular Therapies of the International Society of Blood Transfusion (ISBT) has recently conducted a survey to obtain information from blood establishments worldwide.

MATERIALS AND

METHODS

The survey was created at limesurvey.net and consisted of 29 questions on the use of platelet concentrates (PCs) for HPL production to determine the status, conditions, standardization efforts, area of application, and potential difficulties. The link was sent to all ISBT members, and data were analyzed descriptively.

RESULTS

Of 78 participating centers, 12 routinely produce HPL according to in-house protocols, mainly by pooling expired PCs, whereas quality control testing is established in 10 institutions. HPL is used for basic research (n = 7) and for the manufacture of cell-based medicinal products (n = 7).

CONCLUSION

HPL manufacture is still heterogeneous and limited to a few blood centers worldwide. Prospective collaborations between these institutions may contribute to the efforts for international harmonization and consistent regulation of HPL applications.