Animal biotech company Gallant has entered a fulfillment agreement with MWI Animal Health to establish the first-ever ultra-low-temperature (-80°C) cold-chain distribution network for veterinary practices. The agreement positions clinics nationwide to have safe, reliable access to off-the-shelf stem cell therapies intended for veterinary use, pending FDA approval.
The partnership lays the logistical groundwork for what could be the first FDA-approved off-the-shelf stem cell therapy for companion animals. Combining Gallant’s regenerative medicine innovations with MWI’s national distribution infrastructure, the companies aim to make advanced biologics more accessible and practical for clinics everywhere.
According to the agreement, MWI will create and operate a scalable fulfillment model, including ultra-cold-temperature-controlled storage and shipping. Operations will be based out of MWI’s Kansas facility, with overnight shipping across the continental United States, as well as Alaska, Hawaii, and Puerto Rico.
Sonruvetcel — Gallant’s potential first-in-class, uterine-derived allogeneic mesenchymal stromal cell (MSC) therapy for cats with refractory chronic gingivostomatitis — is anticipated to be the first product supported by the ultra-low-temperature cold chain. If conditionally approved by the FDA’s Center for Veterinary Medicine (FDA-CVM), the therapy would be delivered as an off-the-shelf product for in-clinic use.
“Breakthrough science only matters if we can safely and reliably put it into the hands of veterinary professionals,” said Dr. Linda Black, chief executive officer of Gallant. “With MWI, we are pairing regenerative medicine innovation with world-class supply chain management. This partnership helps ensure that, once approved, veterinarians can conveniently access an FDA-regulated, off-the-shelf stem cell therapy with confidence in its quality and integrity.”
This news comes as a survey conducted by the American Animal Hospital Association and Gallant revealed that:
- Nearly 95% of veterinary professionals expect stem cell therapy to become standard within the next decade.
- The majority (93%) of respondents said they would be more likely to use stem cell therapy if a convenient off-the-shelf product could be delivered via a simple IV procedure.
- Almost half (43%) of the veterinarians surveyed reported that pet owners are already asking about stem cell therapy and regenerative medicine.
“This partnership demonstrates how distribution innovation can unlock clinical innovation,” said Julia Loew, chief commercial officer at MWI Animal Health. “Stem cell therapies require precision handling. By investing in ultra-low-temperature logistics tailored to veterinary practice, we are ensuring that this category of innovation can be delivered in the exact state intended, ready for safe and effective use.”
The infrastructure is ultimately intended to support Gallant’s future therapies targeting inflammatory and degenerative conditions in companion animals.