Freeze-dried plasma offers new transfusion option for dogs with severe blood loss

A freeze-dried plasma product for canine patients is now available for preorder following a risk review by the FDA. The shelf-stable formulation can be mixed with sterile water and administered intravenously in emergencies involving hypovolemia or hemorrhage.

The product, canine freeze-dried plasma (cFDP), developed by Mantel Technologies, is intended for the treatment of hypovolemia and control of hemorrhage in dogs. Unlike traditional plasma products, which typically require frozen storage and thawing before use, the freeze-dried product can be stored in a cool, dry environment and reconstituted rapidly when needed. This may make it useful in acute medical emergencies in dogs, such as trauma cases, military working dog deployments, or remote practice settings where whole blood products are not readily available, the FDA said in an announcement.¹

In December 2025, the FDA’s Center for Veterinary Medicine announced that it had completed a risk review of the product after evaluating its characteristics, manufacturing controls, donor eligibility, and available scientific literature on freeze-dried plasma.¹

“Based on the data and information received, FDA concluded that the developer of Mantel’s cFDP properly identified and appropriately mitigated the potential risks associated with the product,” the agency said in its announcement.¹ The review also found that the plasma has properties similar to other plasma products and that the agency had “no additional safety concerns.”¹

The product has not received FDA approval, conditional approval, or index listing. However, the agency said it does not intend to object to its marketing, stating that the risks associated with Mantel’s cFDP are “appropriately mitigated.”¹

Mantel’s pooled allogeneic cFDP is classified as an animal cell, tissue, and cell- and tissue-based product and is administered intravenously.² The pooled plasma is collected from screened donor dogs, processed, and lyophilized into a powder. According to the FDA’s risk assessment summary, donor animals must undergo screening, disease testing, and health evaluations, which “appropriately mitigates” the risk of infectious disease transmission.² Plasma from multiple donors is pooled, and additional testing is performed on the pooled product before manufacturing proceeds.²

Each kit includes 20 g of freeze-dried plasma packaged in a 250-mL single-use bag, along with a 250-mL bag of sterile water for injection and an administration set.¹ Prior to reconstitution, the product should be stored in a cool, dry environment between 34°F to 77 °F (1-25 °C), out of direct sunlight.³ Once reconstituted, the plasma is equivalent to approximately 250 mL of canine plasma and should ideally be used immediately.⁴ However, it may be kept at room temperature (68-77 ℉) for up to 180 minutes or refrigerated (34-43 ℉) for up to 3 days if the kit is used for a single patient.³ It is administered intravenously at a recommended dose of 10 to 20 mL/kg, at a rate not exceeding about 4 to 6 mL per minute.⁴

Safety data reviewed by the FDA included 3 laboratory studies involving 46 dogs that received intravenous doses of 20 mL/kg.² Investigators evaluated cross-matching safety, the product’s ability to correct coagulopathy, and its effectiveness in supporting perfusion in a model of hemorrhagic shock.²

Adverse events observed during the studies were generally similar to those reported with other plasma transfusions. According to the FDA’s risk assessment summary, cutaneous hypersensitivity reactions occurred in 24 of 46 treated dogs (52.2%), and vomiting occurred in 15 dogs (32.6%).² Most reactions resolved with diphenhydramine treatment, and overall findings supported what the agency described as “a low likelihood of harm to animal recipients of Mantel’s cFDP.”²

The product is available only by prescription through a licensed veterinarian, and the FDA notes that specialized veterinary expertise is necessary for its safe administration.¹

For emergency and critical care veterinarians, the availability of a shelf-stable plasma product may offer a practical addition to transfusion options, particularly in situations where conventional plasma products are unavailable or difficult to store.

References

1. FDA completes risk review of freeze-dried plasma for treatment of hypovolemia and control of hemorrhage in dogs. US Food and Drug Administration Center for Veterinary Medicine. December 18, 2025. Accessed March 10, 2026. https://www.fda.gov/animal-veterinary/cvm-updates/fda-completes-risk-review-freeze-dried-plasma-treatment-hypovolemia-and-control-hemorrhage-dogs
2. Risk assessment summary: Mantel’s canine freeze-dried plasma (VMF 006-295). US Food and Drug Administration Center for Veterinary Medicine. December 16, 2025. Accessed March 10, 2026. https://www.fda.gov/media/190228/download?attachment
3. Canine Freeze-Dried Plasma Kit. Mantel Technologies. Accessed March 10, 2026. https://manteltechnologies.com/cfdp-product-information
4. Freeze-dried plasma now an option for canine emergency treatment. American Veterinary Medical Association. March 5, 2026. Accessed March 10, 2026. https://www.avma.org/news/freeze-dried-plasma-now-option-canine-emergency-treatment?utm_source=delivra&utm_medium=email&utm_campaign=todays-headlines-news