CSL Limited Annual Report 2021/22 49 Advancing innovation at CSL Plasma In March 2022, the US Food and Drug Administration (FDA) provided regulatory clearance of the Rika Plasma Donation System developed by Terumo Blood and Cell Technologies. CSL and Terumo announced a collaboration in 2021 to deliver the new plasma collection platform at CSL Plasma US collection centres. CSL Plasma will begin implementation of the new device as part of the limited market release at centres in the Denver and Colorado area and then continue with full implementation across all US CSL Plasma centers during 2022/23. The Rika system includes technology to support a safe, efficient and improved experience for plasma donors, as well as an improved employee experience. Additional system features support the collection of more plasma, in shorter periods of time. This helps us better serve patients who rely on plasma-based therapies. Benefits of the Rika system include the following. • It completes one plasma collection in 35 minutes or less on average, enabled by the proprietary design of the centrifuge to maximise the plasma yield per cycle. When considering prior average CSL Plasma donation times, this could represent a nearly 30% reduction in average donation time for donors. • It ensures there’s not more than 200ml of blood outside the donor’s body at one time. This is expected to improve the donor’s comfort during the donation and reduce occurrence of a red cell loss deferral. • It is designed with an advanced user interface to guide CSL Plasma front-line employees who operate the device. Status indicators keep donors informed of their donation progress and allow employees more information to assist donors. • The system has built-in safety features that minimise errors and reduce interruptions; and • It features training modules that can be integrated into any learning management system to efficiently train operators and technicians. A clinical trial of the device supported regulatory clearance. Overall, donor satisfaction with the procedure was high during the trial as donors were pleased with the reduced procedure time and often expressed that they felt better at the end of the procedure with the new device than they did during previous donations. Initiatives further support donor experience Our ability to supply life-enhancing and often life-saving therapies is only made possible by ensuring a positive donor experience. All our centres operate to the same standards for the management and care of plasma donors. CSL Plasma has studied several strategies to reduce donor adverse events (AEs), particularly pre-faint or fainting among first-time donors. An analysis of donor adverse events was recently published with the trade association in the medical journal Transfusion, including data fromCSL Plasma and two other companies. This data helped to inform our approach. We have completed two controlled studies evaluating promising interventions based on information in the medical literature. A cross-functional team has been examining the results, and will implement an approach to further reduce AEs in the next financial year. Our focus is to minimise overall AEs, especially among first-time donors. We have also increased proactive health and wellbeing messaging for plasma donors through traditional and digital channels, to support plasma donation and healthier lifestyles. Another study involving a three-year analysis of donor deferrals from 255 centres in the US was published in the Journal of Clinical Apheresis in October 2021. Plasma deferrals occur when initial and periodic onsite screening of donors renders them unable to undertake a plasma donation. The study analysed a total of 4,587,923 events from 255 plasma donation centres (an average of 9% of total donations) over a three-year period (1 April 2017 to 31 March 2020). Most donor deferrals were due to particularly high blood pressure, elevated pulse, low protein and low haematocrit – which is the make-up of blood with blood cells. Although rates of deferrals in other categories have been slightly increasing over time, they comprise a small percentage. Donor education regarding healthy lifestyle choices may improve overall donor health, decrease deferrals and increase source plasma supply. CSL Plasma’s donor app, website and social media channels help raise awareness of and educate donors on lifestyle choices.
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