Validation of a Stem Cell Assay Used as a Key Efficacy Marker for FDA Approval

Presented at CYTO 2024, the 37th annual Congress of the International Society for the Advancement of Cytometry, May 5-8, 2024


The recent announcement by BiolineRx of the FDA approval of APHEXDA™ (motixafortide), represents the first development in stem cell mobilization for the treatment of multiple myeloma to be approved in the U.S. in a decade.  Flow cytometry data generated at Q2 Solutions was fundamental to FDA approval, confirming that the apheresis CD34+ stem cell collection goal of ≥ 6 × 106 CD34+ cells/kg had been reached.. The randomized Phase 3 study was run across five countries in USA and Europe, requiring a robust, globally harmonized stem cell assay to assess efficacy results.


This scientific poster details the results of validation, technology transfer, and QC performance during clinical testing, and includes the production of critical efficacy data.


Q2 Solutions – Karen Smith, Megan McCausland, Alistair Watt
BioLineRx Ltd. Modi'in, Israel – Ella Sorani, Irit Gliko Kabir, Inbal Goldstein, Debby Ickowicz, Liron Shemesh- Darvish


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