Using the Pall RBC In-Line Filtration System to Meet Your Recovered Plasma Production Target

Brenda J. Pina and Robert E. Haime, Pall Medical

How will the changing economic environment affect your plasma acquisition goals and what actions can you take to maximize your revenue opportunities for the future? The answer to this strategic question will influence your organization’s ability to grow and compete in the global plasma marketplace.

The late Thomas ‘Tip’ O’Neill, Jr., former Speaker of the House from Massachusetts was perhaps best known for his advice to colleagues to attend carefully to their constituents, because, as he put it, "All politics is local." When you apply this advice to your business, it means that every day, even with the increased use of aphaeresis technology, your facility must collect manual whole blood donations to address local blood needs. You can maximize the value of these ‘every day’ manual whole blood donations to get the red cells you need locally and increase your potential to improve plasma yields and your revenue stream within the global plasma market. To achieve optimal operational efficiency for leukoreduction with plasma production using a red blood cell (RBC) in-line filtration system - the Leukotrap® RC System with RC2D Filter – could be the one ‘universal’ in-line filtration system you may need.

Plasma Processing 101

Deciding whether to use a whole blood (WB) in-line filtration system versus a RBC in-line filtration system is a trade off between plasma yields and logistics. As illustrated in Figure 1 below, there will be blood held up in the WB filter that affects the amount of plasma obtained after centrifugation.

Plasma Yield Dynamics - WB vs. RBC In-line Systems

Depending on your current processing methods, use of the Leukotrap RC System with RC2D Filter could increase plasma yields by as much as 5-10% over whole blood (WB) in-line filtration systems (Figure 2).

Plasma Recovery - WB vs. RBC In-Line Systems

Improving Recovered Plasma Yields with Automated Expressors

So using an RBC in-line filtration system such as the Leukotrap RC System with RC2D filter will produce similar plasma yields as a non-filter collection system because the plasma is expressed before filtration. Plasma yields are maximized, and the filter is designed to process the resulting high hematocrit RBC’s.

But what about centers that may be using automated expressors? In one case study, a facility obtained increased plasma yields with the Leukotrap RC System with RC2D Filter when used in conjunction with the Compomat® G4. This facility reported1 that when they processed plasma from the Leukotrap RC System with RC2D Filter using the Compomat® G4, they received a complaint from their recovered plasma vendor that their boxes of recovered plasma were ‘bulging and were not closing properly’. They were instructed to reduce the number of plasma units placed in one box from 24 to 20. Upon further investigation, they found that they had an average increase in plasma yield from years 2003 to 2004 of approximately 7 grams/unit. When they converted to just plasma production and optimized the programs on the Compomat G4, they had an average increase of 21 grams of plasma per unit in year 2005. Their increase in revenue from recovered plasma also supported this conclusion.

Operational Efficiency and cGMPs

Let’s take a closer look at current production logistics. In order to maximize plasma yield, whole blood is centrifuged under harder spin conditions. In addition, the plasma is often expressed until the red cells begin to exit the main collection bag. The result – RBCs that have a high hematocrit that may cause filter plugging and/or slow flow when filtered.

The Leukotrap RC System with RC2D Filter has been designed to handle hard spun blood that has been held up to 72 hours at 1-6 C. This allows for greater flexibility for component staff scheduling, e.g. units arriving late on Friday can be processed on Monday reducing the need for Saturday filtration staffing.

Because of the novel design of the RC2D Filter, processing methods to maximize plasma recovery can be used with less concern for extended filtration times or filter plugging. With a mean filtration time2 of 37.2 minutes for hard spins (13.4 minutes for a soft spin), you can gain operational efficiency that can increase production throughput while retaining confidence in your cGMP compliance with the RC2D Filter’s ability to reliably meet and/or exceed white cell residuals and red cell recovery requirements across a broad range of processing conditions.

Balancing Plasma Production with other Product Inventory Targets

The Leukotrap RC System with the RC2D Filter may be the only WB collection system you need to provide you with maximum flexibility. Whether you need to maximize plasma yield or increase platelet availability, now you can collect whole blood in one system and produce leukoreduced RBC, and non-leukoreduced plasma and/or platelets based on planned or emergent product needs. Increase platelet availability by taking these non-leukoreduced platelets which can be pooled and leukoreduced using the Acrodose™ PLus System to make a transfusion-ready, therapeutic dose of platelets that are clinically equivalent to a single donor platelet – an AcrodoseSM Platelet.

An Acrodose Platelet is a leukoreduced, pooled, ABO matched and bacteria-tested product made from whole blood derived platelets. This innovative product can provide you with many of the benefits of apheresis platelets, e.g. leukoreduced, transfusion-ready for the hospital, consistent dosing, efficient bacteria detection, and combines them with all the benefits of WB-derived platelets, e.g. low cost, plentiful supply, and meeting the AABB guidelines on TRALI. The result is a product that improves platelet safety and availability, usually at a lower cost than single donor platelets while providing the highest levels of safety with no clinical sacrifice to platelet quality. This product can further benefit your facility if you are strategically looking to increase product availability and reduce importing, all while keeping an eye on costs.

Final Thoughts

In summary, the path you take to optimize your plasma yields is unique to your facility. The Leukotrap RC System with the RC2D Filter can be an effective resource as you consider your strategies to navigate within the changing economic environment. This system provides your facility with options, and has been designed to help you in achieving your strategic goals. Whether you need to maximize plasma yields or increase platelet availability, you can achieve both goals with one system.

And as a result, your facility can
  • Streamline processes
  • Eliminate waste
  • Deliver high quality blood products
  • Improve profitability and your bottom-line
Now there’s no compromise in order for your facility to grow and compete in the both the local and global plasma marketplace.

COMPOMAT is a registered trademark of Fresenius Kabi AG, a subsidiary of Fresenius SE.
Leukotrap and Acrodose are registered trademarks of Pall Corporation.
Acrodose is a service mark of Pall Corporation.

1 Presented at the Industry Workshop, ‘Maximizing the Value of Whole Blood Donations’, AABB Annual Meeting & TXPO, Montreal, Canada, 2008.
2 Data available upon request.