Development research leads to Canada’s first plasma reduced HPC unit
Apheresis machines are used to isolate autologous blood stem cells from adult donors (a.k.a. Human Progenitor Cells (HPC)). An update in HPC apheresis system technology at the Edmonton hospital led to higher HPC collection volumes as additional plasma was being collected with the stem cells. This resulted in greater DMSO (freezing solution) load to patients and unacceptably long transfusion times. Canadian Blood Services Stem Cell Manufacturing Lab had to optimize its process to maintain product quality.
The Centre for Innovation Product and Process Development team provided its expertise to find a way to reduce the product volume while maintaining the stem cell count and quality. The researchers tested a volume reduction process (Sepax 2) using mock HPC units derived from buffy coats obtained from blood donors. They demonstrated that the process successfully reduced the product volume with high reproducibility and minimal impact on quality. This reduction lowered the amount of DMSO in the final product. Based on these findings, the team made several recommendations to guide the implementation of volume reduction by Canadian Blood Services. These included detailed guidelines for the volume reduction process, a recovery protocol, and post-implementation monitoring.
The volume reduction process was successfully implemented by Canadian Blood Services on March 22, 2017. This is the first Canadian lab to implement the Sepax 2 process for autologous HPC products. This leadership ensures the provision of high quality autologous stem cell products to Canadian patients.