Nanofiltration of single plasma donations: feasibility study

Area of Science:

• Biomedical Engineering
• Blood Transfusion
• Virology

Background:

• Advancements in human plasma processing aim to enhance transfusion and fractionation safety.
• Nanofiltration is an emerging technology for purifying biological products.

Purpose of the Study:

• To evaluate the feasibility of a 75-nm and 35-nm nanofiltration process for human plasma.
• To assess the impact of nanofiltration on plasma quality and viral clearance.

Main Methods:

• Human apheresis plasma underwent leucoreduction and sequential nanofiltration (75-nm then 35-nm membranes) at 35°C.
• Plasma quality parameters were measured, and viral clearance was tested using Hepatitis C virus (HCV)-spiked plasma.
• HCV detection was performed using RNA polymerase chain reaction (PCR) and branched-chain DNA assays.

Main Results:

• Reproducible nanofiltration of leucoreduced plasma was achieved with a flow rate of 450 ml/h.
• Filtered plasma met in vitro specifications for transfusion/fractionation, with minimal protein loss and no coagulation activation.
• HCV RNA was undetectable by PCR and branched-chain DNA assays after filtration through the 35-nm membrane.

Conclusions:

• A 75-nm + 35-nm nanofiltration process is feasible for leucoreduced human plasma.
• This technology shows potential for improving plasma safety by removing cellular debris and infectious agents like HCV.
• Nanofiltration offers a promising approach for enhancing the quality and safety of plasma products.