In Focus
Spray-dried plasma update
Potential in pre-hospital, military, and remote settings
Prompt transfusion of plasma can improve survival in patients with massive bleeding. Most plasma components require cold-chain storage: plasma is often stored frozen (long-term, usually up to a year) or as liquid plasma in a refrigerator (shorter-term, including storage of thawed, previously frozen units). This means plasma may not be available where it is arguably needed most, i.e. pre-hospital and in austere or remote environments where access to blood products can be challenging. Improved plasma availability in these settings could be advantageous for both civilian and military applications.
Freeze-drying – an enduring solution for plasma storage
Plasma storage was first solved many decades ago. Freeze-dried, or lyophilized, plasma was used extensively during World War II. The freeze-drying process flash-freezes plasma and uses a vacuum to dehydrate it into a room-temperature stable powder that can be reconstituted before use. The process preserves proteins, such as plasma clotting factors, while overcoming the cold-chain storage limitations of other forms of plasma. However, within a few decades of the end of World War II, freeze-dried plasma was abandoned due to safety concerns related to viral contamination.
In more recent decades, and applying modern pathogen safety approaches, freeze-dried plasma has re-emerged. Currently available freeze-dried plasma products include:
- French Lyophilized Plasma [FLyP] (French Military Blood Institute, France)
- LyoPlas N-w (German Red Cross, Germany)
- Bioplasma FDP, (National Bioproducts Institute, South Africa)
- OctaplasLG Powder® (Octapharma, Lachen, Switzerland)
The first three products have a longer history of use, while the Octapharma product received regulatory approval from European medical authorities in 2023. In addition, a US-based company, Teleflex Inc., is developing a lyophilized single-donor plasma product (EZPlas™) made from fresh frozen plasma and packaged in a blood bag, rather than a glass vial.
The newer kid on the block – spray-dried plasma
Freeze-dried plasma demonstrated the feasibility and utility of dried plasma products, and interest has recently expanded to alternative drying technologies that may offer manufacturing and operational benefits. Spray-drying is well-established in other industries, such as pharmaceutical and dairy, but applying it to plasma is relatively new, with initial studies emerging in the early 2010s. Like freeze-drying, spray-drying processes plasma into a room temperature-stable powder. The methods differ, however, with spray-drying using heat to evaporate microdispersed droplets created by atomization of a continuous flow of plasma to produce a fine powder. In vitro and in vivo pre-clinical animal studies have reported that spray-dried plasma retains function, with labile factor levels and measures of global coagulation reported to be similar to those of conventional plasma.
Why spray-dried plasma?
Like freeze-dried plasma, spray-dried plasma offers several advantages over conventional plasma. It is a stable product with no requirement for frozen storage or cold-chain capabilities, with the associated logistical benefits. Dried plasma can be quickly reconstituted in water. Spray-drying produces a finer, more consistent powder than freeze-drying, and reconstitution takes less than 5 minutes – slightly quicker than freeze-dried plasma. Finally, all approved freeze-dried plasma products are packaged in glass vials or bottles, while spray-dried plasma currently in development is intended to be packaged in a transfusion-ready plastic bag, offering practical advantages for product transport and packaging.
What is the status of current development efforts?
Velico, a US-based company, is developing a plasma spray-drying method and associated device (Frontline ODP™ technology) that can be installed and used by blood centres. To the author's knowledge, this is currently the only spray-dried plasma product in active development. Velico’s decentralized approach to spray-drying plasma is intended to enable blood centres to manufacture the product themselves. This has potential benefits with respect to product self-sufficiency and leveraging established donor bases, expertise, and supply and distribution chains. This approach may also permit the most flexibility in terms of stockpiling and/or surge capability, giving blood manufacturers greater resilience and scope to respond to various emergencies, be it the emergence of a novel blood-borne pathogen, or mass casualty events.
What are latest development updates?
Two recent publications have provided detailed in vitro characterization of Velico’s FrontlineODP™ product. In May 2026, Sohn et al. published an extensive in vitro characterization comparing it with conventional plasma. In July 2026, Bower et al. published the first in vitro data of spray-dried plasma produced using the FrontlineODP™ system in the UK. Both papers found overall acceptable levels of coagulation proteins. I recommend anyone interested in pursuing spray-dried plasma read these studies to gain a more detailed understanding of their findings on in vitro product quality.
For freeze-dried plasma, decades of data have demonstrated low adverse event rates but there is significantly less experience with spray-dried plasma. However, the first safety data emerged in May 2026, when Cancelas et al., published a multicenter, randomized, dose-escalation, first-in-human phase I clinical trial of the FrontlineODP™ System. This study found equivalent safety of spray-dried plasma and conventional plasma, including, importantly, no serious adverse events. These findings represent an important milestone, although the product remains investigational and has not yet received regulatory approval.
Much remains to be done
As noted in a 2025 review by Mitra et al., spray-dried plasma is an attractive plasma product that offers substantial benefits over conventional plasma with regards to manufacture, storage, transport, reconstitution, and delivery. However, there remain many open questions, with basic research and clinical avenues to be explored, including:
- What is the efficacy of spray-dried plasma for hemostatic resuscitation?
- What do the in vitro characterization data tell us? Will in vitro observations regarding, e.g., vWF activity levels, translate to clinical impacts?
- What are the boundaries of the product’s temperature stability? Is the product stable as it moves through multiple temperatures, and if so, for how long?
- Could optimized reconstitution solutions and/or volumes improve the product’s hemostatic profile?
- How will blood operators balance the need for spray-dried plasma vs. demand for other forms of transfusable plasma and plasma-derived medicines?
With additional research and clinical studies, these questions and more can be addressed. If successful, spray-dried plasma has the potential to become an important clinical resource, particularly in pre-hospital, military, and remote settings.
References
- Pusateri AE, Pati S, Silverman TA, Dudaryk R, Rappold JF, Buckley L, et al. The need for dried plasma—Still a national issue: Where are we and recommendations. Transfusion. 2026.
- Booth, G. S., Lozier, J. N., Nghiem, K., Clibourn, D., Klein, H. G., & Flegel, W. A. Spray: single-donor plasma product for room temperature storage. Transfusion. 2012.
- Liu QP, Carney R, Sohn J, Sundaram S, Fell MA. Single-donor spray-dried plasma. Transfusion. 2019.
- Sohn J, Fell MA, Gingras L, Buckley LA, Popovsky MA, Cap AP. Spray-dried plasma is comparable to conventional plasma products used in the resuscitation of major hemorrhage: In vitro characterization. Transfusion. 2026.
- Bower L, Huish S, Oleniacz K, Ellington M, Robbins MJ, Woolley T, et al. Spray dried plasma manufactured from apheresis and whole blood derived plasma. Transfusion. 2026.
- Cancelas JA, Buckley L, Leitman SF, Nestheide S, Gingras L, Munoz D, et al. Next generation spray-dried on-demand plasma: A multicenter, randomized, dose-escalation, first-in-human safety study. Transfusion. 2026.
- Mitra B, Biggins PJC, Marks DC, Reade MC. Coagulation factors in spray-dried plasma: A systematic review and meta-analysis. Transfusion. 2025.
