Kamada Receives FDA Approval for In-House Rabies Virus Neutralization Testing Laboratory
核心洞察
Kamada Ltd. announced FDA approval of its new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) laboratory, the gold standard for measuring rabies-neutralizing antibodies (搜索).
The new laboratory will support quality control testing for KEDRAB and KAMRAB manufacturing, representing over $70 million in sales for 2025.
The facility enables increased operational efficiencies and reduces reliance on external testing while meeting stringent safety, quality and GMP standards.
Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA) announced FDA approval of its new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) laboratory, marking a significant expansion of the company's advanced testing capabilities for anti-rabies (搜索) potency testing. The RFFIT is recognized as the gold standard neutralizing test used to measure the level of rabies-neutralizing antibodies (搜索).
Enhanced Quality Control Capabilities
The new laboratory is part of Kamada's Quality Control laboratory network and will support the manufacture of KEDRAB® and KAMRAB®, the company's rabies (搜索) immunoglobulin products. Located in Kamada's plant in Beit Kama, Israel, the facility is one of a limited number of laboratories worldwide capable of performing such specialized tests.
The RFFIT test is used by Kamada to quantify anti-rabies (搜索) potency throughout all key steps of KEDRAB and KAMRAB manufacturing, from plasma collection and sourcing to final product release. Prior to receiving FDA approval, the laboratory was also approved by Health Canada and the Israeli Ministry of Health.
Commercial Impact and Operational Benefits
In 2025, Kamada's sales of KEDRAB and KAMRAB totaled over $70 million, representing the leading franchise in the company's portfolio of specialty plasma-derived products. The new laboratory is designed to meet stringent safety, quality and GMP standards while providing increased operational efficiencies.
"Our new state-of-the-art RFFIT laboratory supports our continued progress as a leading global vertically integrated specialty plasma-derived company," said Amir London, Kamada's Chief Executive Officer. "The new laboratory will enable increased operational efficiencies through utilization of our in-house, highly professional capabilities supported by external testing expertise."
Strategic Significance
The establishment of the laboratory demonstrates Kamada's ongoing commitment to innovation, scientific excellence, and investment in advanced quality infrastructure. The facility will reduce reliance on external testing facilities, improve efficiency, and provide greater flexibility in meeting regulatory requirements.
Rabies (搜索) remains a fatal viral disease without timely treatment, making neutralization assays critical for evaluating the potency of rabies immunoglobulin products. The new laboratory allows Kamada to conduct these specialized tests internally, ensuring faster turnaround times and greater control over quality standards.
The facility will support both commercial operations for KEDRAB, which is marketed in the U.S. through partner Kedrion Biopharma (搜索), as well as ongoing clinical development programs and regulatory submissions. This approval strengthens Kamada's quality control and regulatory capabilities while supporting both commercial and clinical programs as the company continues to expand its portfolio of plasma-derived therapies across infectious diseases, immunology, and critical care.