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Bluejay Diagnostics Announces Completion of Commercial-Scale IL-6 Antibody Production
Globenewswire· 2025-12-29 12:00
Core Insights - Bluejay Diagnostics, Inc. has completed commercial-scale production of polyclonal and monoclonal antibodies targeting interleukin-6 (IL-6), relevant for inflammatory and critical-care applications [1][2] Group 1: Antibody Production - Both polyclonal and monoclonal antibodies have met internal performance criteria for use in Symphony™ cartridge manufacturing intended for clinical and potential future commercial applications [2] - The company has generated polyclonal antibodies using both third-party and internally developed immunogens, intending to utilize antibodies from its proprietary immunogen for ongoing development activities [3] - Monoclonal antibodies produced by the company have demonstrated acceptable binding, specificity, and signal performance characteristics for their intended diagnostic use based on internal testing [3] Group 2: Production Capacity - Bluejay estimates sufficient material to support the production of over nine million Symphony cartridges for clinical and commercial manufacturing purposes [4] - The company has established the capability to produce additional antibodies as needed [4] Group 3: Product Development - The Symphony™ system remains under development and is subject to further validation, regulatory review, and clearance, with no assurance regarding the timing or success of these activities [5] - The Symphony System is designed for rapid, near-patient testing for sepsis triage and monitoring disease progression, with the first product candidate being an IL-6 Test for sepsis [6]