FDA clears ‘rapid’ Terumo BCT collection system as demand for plasma-based therapies grows worldwide

By Jane Byrne

- Last updated on GMT

© GettyImages/choja
© GettyImages/choja

Related tags Plasma immunoglobulins Terumo immunodeficiency apheresis

The US Food and Drug Administration (FDA) has cleared a new plasma collection system developed by Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company based in Colorado.

Rika is a next-generation, automated technology designed to help meet growing market demand for plasma-derived medications.

“The technology will enable the collection of more plasma, in shorter periods of time with a better donor experience,”​ said Cynthia Hogum, senior vice president, global quality transformation and general manager, plasma innovations, Terumo BCT. 

The global blood plasma products market is forecasted to grow at a CAGR of 6.8% due to an increasing, critical, and ongoing need for human plasma-based therapies. It will reach US$28.5bn in 2023 from US$20.5bn in 2018, according to a research report​.  

Terumo BCT joined forces with CSL Plasma, a subsidiary of global biotherapeutics company, CSL Behring, which manufactures plasma-derived therapies for people in over 100 countries, to develop and roll out the new plasma collection technology.

Rika is to debut this spring in a limited market release at CSL Plasma collection centers, said Terumo BCT.

Massive cut expected in donation time  

CSL Plasma outlined the benefits of the technology:

“Rika completes one plasma collection in 35 minutes or less, on average [for an 880mL collection, including saline return]. When considering prior average CSL Plasma donation times, this could represent a nearly 30% reduction in average donation time for donors. It ensures there is not more than 200 ml of blood outside the donor’s body at one time. This is expected to improve the donor’s comfort during the donation and reduce the occurrence of a red cell loss deferral.”

Terumo BCT said Rika’s advanced control system also enhances donor safety by monitoring the process and providing alerts and visual cues that guide the operator. Rika makes automatic adjustments during each procedure, enabling a more seamless operator experience and the ability to spend more time with the donor, added the developer.

The company said investing in the source plasma industry is a natural evolution for its portfolio given its "experience and leadership"​ in apheresis technology.

It would not disclose the financials around the project, though Hogum told BioPharma-Reporter: "Rika represents a significant investment in innovation and development and infrastructure to meet our customer needs, execute a successful implementation and ensure long-term business continuity.”

Optimizing US plasma collection

Rika is part of an extensive ecosystem that integrates plasma collection technology, IT solutions, services, and program support, said Terumo BCT. 

Hogum said the development has global implications: “Two thirds of the plasma that is processed globally comes from the US. In addition, there is a worldwide need for more plasma-derived medicinal products (PDMPs), so improving plasma collection helps to reach our mission of serving more patients.”

Currently, it can take 130 donations to treat one patient with a primary immunodeficiency for a year, according to the Plasma Protein Therapeutics Association (PPTA).

Volumes ‘struggling’ to meet demand

There are more than 1,500 indications for plasma treatments today, noted Hogum.

“And the number of patients diagnosed with conditions that can be treated with plasma-based treatments is increasing thanks to access to medical care, new products and applications and diagnostic advances.”

Over the past 10 years, the use of immunoglobulins – among the most commonly used PDMPs – has almost doubled, reported the PPTA.

“The volume of plasma collected is struggling to keep up with current worldwide demand, though, along with expected growth from numerous investigational trials. In Europe, for example, the volume of plasma collected ​only meets 63% of current clinical needs.

“As the US collects around 67% of worldwide plasma, collectors such as CSL Plasma need an innovative technology solution to meet gobal demand for plasma products,” ​added Hogum. 

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