CEL-SCI Corporation reported that its Multikine® (Leukocyte Interleukin, Injection) cGMP dedicated manufacturing facility commissioning has been completed. 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 (ICH), and in compliance with regulatory guidelines, CEL-SCI undertook commissioning and qualifying the facility?s utilities, systems, and equipment.
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- CEL-SCI Corporation Completes Commissioning of Its Multikine Manufacturing Facility for Commercial Scale Production of Head & Neck Cancer Drug