CEL-SCI announces Multikine cGMP dedicated facillity commissioning completed

CEL-SCI reported that its Multikine or Leukocyte Interleukin, Injection, cGMP state-of-the-art dedicated manufacturing facility commissioning has been completed. “This is a very significant milestone in bringing Multikine to market since the manufacturing facility is part of a planned Biologics License Application required for approval of Multikine in the treatment of head and neck cancer,” stated CEL-SCI’s CEO Geert Kersten. Originally constructed to supply Multikine for the world’s largest global pivotal Phase 3 trial in locally advanced squamous cell carcinoma of the head and neck, CEL-SCI’s facility has been expanded and upgraded in preparation for the Company’s submission of Multikine for regulatory approval and commercial scale manufacturing. In keeping with CEL-SCI Validation Master Plan, industry standards, International Society for Pharmaceutical Engineering ISPE guidelines, International Conference for Harmonization and in compliance with regulatory guidelines, CEL-SCI undertook commissioning and qualifying the facility’s utilities, systems, and equipment.