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

The research paper focuses on implementing a high-speed, continuous-flow, automated method of plasmapheresis for efficient equine (horse) plasma collection while complying with current good manufacturing practices. It presents promising results based on procedures performed on 143 horses over 5 years, harvesting over 50,000 litres of sterile equine plasma.

Automated Plasmapheresis Procedure

• The study aimed to mechanize the process of plasmapheresis, a procedure that extracts plasma from blood. The ultimate goal was to overcome the constraints of manual methods, thereby streamlining and making the plasma collection process more efficient.
• Adaptations were made to automated plasmapheresis instruments and sterile disposable collection sets to permit continuous dual-instrument operation.
• Each horse was linked to the device using two catheters, each inserted in a jugular vein. This mechanism allowed for the simultaneous extraction of whole blood and return of concentrated cells.

Procedure Frequency and Plasma Volume

• The plasmapheresis procedure was conducted at 14-day intervals on donor horses. The maximum volume of plasma harvested during each procedure was 22 mL for each kilogram of the horse’s weight.
• Over a 5-year period, 3,240 plasmapheresis procedures were conducted, yielding more than 50,000 litres of sterile equine plasma, all in alignment with current good manufacturing practice.

Observations and Findings

• During the plasmapheresis procedures, the donor horses remained calm and tolerated the processes well. This underscores the procedure’s safety and comfort level for the animals.
• The frequent and high-volume collection of plasma did not cause sustained hypoproteinemia (abnormally low levels of protein in the blood) in the donor horses. This demonstrates that the procedure does not have a long-term negative health impact on the donors.
• Adverse events associated with the automated plasmapheresis process were rare and could be mitigated through minor adjustments to the procedure.

Conclusion

• The automated plasmapheresis procedure highlighted in this study offers a substantial potential for large-volume equine plasma collection. Moreover, the process can be used to safely carry out therapeutic plasmapheresis procedures in horses.