Development of an automated plasmapheresis procedure for the harvest of equine plasma in accordance with current good manufacturing practice.

ABSTRACT

OBJECTIVE: To develop a high-speed, continuous-flow, automated plasmapheresis procedure for the high-volume harvest of equine plasma in accordance with current good manufacturing practice. ANIMALS 143 horses (predominantly draft breeds) between 3 and 10 years of age at the time of purchase. PROCEDURES Adaptations were made to automated plasmapheresis instruments and sterile disposable collection sets, which allowed for dual-instrument, continuous-flow operation. Donor horses were connected to the apparatus via 2 catheters (1 inserted in each jugular vein). The instruments removed whole blood from donors, fractionated the blood, diverted plasma to collection bags, and simultaneously returned concentrated cells to the donors. Plasmapheresis was performed on donor horses at 14-day intervals with a maximum of 22 mL of plasma/kg of donor body weight harvested during each plasmapheresis procedure. RESULTS: During a 5-year period, 3,240 plasmapheresis procedures were performed and > 50,000 L of sterile equine plasma was harvested in accordance with current good manufacturing practice. Donors typically remained calm during the plasmapheresis procedures and tolerated the procedures well. The high-volume and frequent plasma harvest did not result in sustained hypoproteinemia in donor horses. Adverse events associated with the automated plasmapheresis technique were infrequent, and the recurrence of adverse events was minimized by making minor adjustments to the procedure. CONCLUSIONS AND CLINICAL RELEVANCE The automated plasmapheresis procedure described in this report can be used to safely harvest equine plasma or to perform therapeutic plasmapheresis in horses.