CEL-SCI Corporation reported that its Multikine* (Leukocyte Interleukin, Injection) cGMP state-of-the-art dedicated manufacturing facility commissioning is substantially complete, a significant milestone toward a planned Biologics License Application (BLA) with several regulatory agencies for approval of Multikine in the treatment of head and neck cancer.
Originally constructed and validated 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 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 is commissioning and qualifying the facility’s utilities, systems, and equipment. The facility will be subject to regulatory review prior to the granting of a commercial manufacturing license and marketing clearance for Multikine in the treatment of head and neck cancer.
“Due to the high degree of manufacturing complexity, company-specific know-how, and trade secrets involved in the production of Multikine, the commissioning of our facility is a substantial part of the BLA which we intend to file with regulators including the U.S., Canada, UK, and Europe. Our team has worked diligently over the past few years adding complex improvements to the facility, to get us to where we are today, and we are very proud of what has been achieved,” stated CEL-SCI’s CEO Geert Kersten.
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