FDA clears Terumo’s Rika system, a plasma collection device

USA – The US Food and Drug Administration has approved a novel plasma collection device designed by Terumo Blood and Cell Technologies (Terumo BCT) and CSL Plasma, a plasma collection network to meet the rapidly increasing demand for human plasma-based therapies.

The companies, which are Terumo Corp. and CSL Ltd. subsidiaries, signed a collaboration agreement in 2021 to develop the new Rika device for CSL Plasma collection centers.

Rika was created in response to the industry’s need for technological advancement and process improvements in order to increase efficiency and quality while ensuring donor safety and a sufficient plasma supply.

Rika is a component of a large ecosystem that includes plasma collection technology, IT solutions, services, and program support.

All of this is expected to boost center productivity and efficiency, allowing plasma collections to be optimized and patients who rely on plasma-derived therapies to be met.

According to the companies, the Rika system ensures that no more than 200 mL of blood is outside the donor’s body at any given time and reduces collection time by 30 percent — to about 35 minutes or less— compared to existing technology averages.

Plasma donations currently take about 1 hour and 15 minutes on average, according to the Red Cross.

Plasma-based therapies, which are currently used for approximately 1500 indications, have been designated as essential medicines by the World Health Organization.

Furthermore, according to the Plasma Protein Therapeutics Association, it can take 130 plasma donations to meet the annual needs of just one patient with a primary immune deficiency, and approximately 1200 for a patient with hemophilia.

The Rika system expedites the process of meeting these needs and is intended to improve donor safety and comfort, according to the companies in a press release announcing the FDA approval.

Given Terumo Blood and Cell Technologies’ experience and leadership in apheresis technology, investing in the source plasma industry is a natural evolution in the Terumo Blood and Cell Technologies portfolio.

As a global innovation partner, the company invests three times more in development than the industry average.

A limited market release of the system at CSL Plasma collection centers is planned for this spring, followed by a full US rollout later in the year.

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