Kamada Announces FDA Approval of its New In-House Rabies Virus Neutralization Testing Laboratory

FDA Approves Kamada's New In-House Rabies Testing Lab

Kamada Ltd. announced FDA approval for its new in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) laboratory, located in Beit Kama, Israel. This state-of-the-art facility, already approved by Health Canada and the Israeli Ministry of Health, significantly expands Kamada's advanced testing capabilities for Anti-Rabies potency, crucial for the manufacturing of KEDRAB® and KAMRAB®. The RFFIT is the gold standard for measuring rabies-neutralizing antibodies and is utilized throughout the manufacturing process of these products, which generated over $70 million in sales for Kamada in 2025. The new lab aims to enhance operational efficiencies and demonstrates Kamada's commitment to quality infrastructure.

• Kamada's new RFFIT laboratory has received FDA approval, following prior approvals from Health Canada and the Israeli Ministry of Health. This makes it one of a limited number of laboratories globally capable of performing such specialized rabies virus neutralization tests. The lab, located in Beit Kama, Israel, was designed to meet stringent safety, quality, and GMP standards, underscoring its high operational and regulatory compliance.
• The in-house RFFIT laboratory significantly expands Kamada's advanced testing capabilities for Anti-Rabies potency, which is critical for the manufacturing of its key products, KEDRAB® and KAMRAB®. By bringing this testing in-house, Kamada expects to achieve increased operational efficiencies and leverage its professional capabilities, supporting its strategy as a vertically integrated specialty plasma-derived company.
• The RFFIT test is integral to quantifying Anti-Rabies potency throughout the entire manufacturing process of KEDRAB and KAMRAB, from plasma collection to final product release. These products represent Kamada's leading franchise, with combined sales exceeding $70 million in 2025, highlighting the strategic importance of this new laboratory in supporting the continued growth and quality assurance of its core specialty plasma-derived portfolio.

The Critical Role of Rabies Prophylaxis in Global Health

Current rabies treatment guidelines are built around the World Health Organization's exposure classification system, which categorizes potential rabies exposures into three distinct categories that determine the appropriate prophylactic response. Category 1 exposures (touching or feeding animals, licks on intact skin) require no treatment. Category 2 exposures (nibbling of uncovered skin, minor scratches without bleeding, licks on broken skin) require immediate vaccination but no rabies immunoglobulin. Category 3 exposures (single or multiple transdermal bites or scratches, contamination of mucous membranes with saliva) represent the most severe category and require both vaccination and rabies immunoglobulin administration. The mode and intensity of exposure fundamentally determine the choice of treatment regimen, which encompasses wound care, active vaccination, and passive immunization when indicated.

Post-exposure prophylaxis protocols have evolved significantly, with current WHO recommendations specifying that rabies immunoglobulin must be administered directly at the bite site rather than using the outdated 50:50 method where half was given at the bite site and half elsewhere. This change addresses treatment failures attributed to inadequate immunoglobulin levels in wounds. For previously unvaccinated individuals with Category 3 exposure, the standard protocol involves rabies immunoglobulin administration plus a series of vaccine doses. Previously vaccinated individuals follow a simplified regimen requiring only vaccine doses without immunoglobulin, as pre-exposure vaccination simplifies post-exposure management and may provide protection against unrecognized exposures.

Pre-exposure prophylaxis is recommended for individuals at elevated risk of rabies virus contact and can achieve nearly 100% effectiveness when combined with appropriate post-exposure measures. Various pre-exposure schedules exist across different jurisdictions, with both two-dose and three-dose regimens showing similar short-term seroconversion rates regardless of administration route. However, three-dose intramuscular schedules demonstrate superior long-term maintenance of protective antibody levels compared to two-dose regimens. A virus neutralizing antibody titer of at least 0.5 IU/ml indicates effective vaccination, and almost all individuals achieve seroconversion following booster doses regardless of their initial vaccination schedule.

Kamada's New RFFIT Lab: A Strategic Leap in Rabies Biologics Quality

Kamada's recent FDA approval for its in-house Rapid Fluorescent Focus Inhibition Test (RFFIT) laboratory in Israel represents a strategic move to solidify its position in the critical rabies biologics market. This state-of-the-art facility, already recognized by Health Canada and the Israeli Ministry of Health, is pivotal because the RFFIT is the gold standard for accurately quantifying rabies-neutralizing antibodies. For products like KEDRAB® and KAMRAB®, which are essential components of post-exposure prophylaxis (PEP) against a disease with a near 100% fatality rate, ensuring the highest level of potency and quality is non-negotiable.

Bringing this advanced testing capability in-house offers several strategic advantages. It provides Kamada with enhanced operational control over a crucial manufacturing step, potentially streamlining batch release and reducing reliance on external testing facilities. This commitment to quality infrastructure reinforces the company's dedication to regulatory compliance and can bolster confidence among healthcare providers and patients in the reliability of its products. Furthermore, an internal, FDA-approved RFFIT lab creates a robust platform for future research and development, enabling more agile testing of new vaccine candidates or improved biologics.

However, this investment also comes with inherent risks. While RFFIT is the current benchmark, studies indicate it is a labor-intensive and expensive assay. The emergence of more rapid and potentially automated alternatives, such as icELISA-based neutralization tests, could challenge the long-term cost-effectiveness of a dedicated RFFIT facility. Moreover, the broader market for rabies prophylaxis faces challenges, including issues with patient compliance due to complex, multi-dose regimens and the significant financial burden of PEP, which can impact consistent demand. The dynamic landscape of rabies research, with ongoing efforts to develop single-dose vaccines, adjuvanted formulations, and monoclonal antibody cocktails, suggests that future treatment paradigms may evolve, potentially affecting the market position of existing human rabies immune globulin (HRIG) products like KEDRAB®. Kamada's move strengthens its current foundation but necessitates continuous adaptation to scientific advancements and market shifts.