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CEL-SCI Corporation Completes Commissioning of Multikine Facility

Marks a key milestone that is a prerequisite to filing a Biologics License Application with the FDA and other regulators for marketing approval.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

CEL-SCI Corporation’s Multikine (Leukocyte Interleukin, Injection) cGMP dedicated manufacturing facility commissioning has been completed—marking a milestone in bringing Multikine to market.
 
“The high degree of complexity involved in manufacturing Multikine has required tremendous investment and time on CEL-SCI’s part. Our manufacturing trade secret, capability, and know-how are high-value key strategic assets that would be very difficult for others to replicate. This achievement marks a very big step towards the preparation of Multikine for marketing approval,” 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 (ICH), and in compliance with regulatory guidelines, CEL-SCI undertook commissioning and qualifying the facility’s utilities, systems, and equipment.

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