CEL-SCI Corporation announced it has completed the expansion of its existing dedicated Multikine* (Leukocyte Interleukin, Injection) cGMP manufacturing facility. The expansion was undertaken in anticipation of filing a Biologics License Application (BLA) which, if approved, will allow Multikine produced in the facility to be commercially distributed. The construction, which began in 2020, expanded the facility and added various upgrades to ensure it will be in compliance with all requirements of the FDA’s Current Good Manufacturing Practice (GMP) regulations. The facility’s production capacity has been doubled to meet anticipated market demand for Multikine once it is licensed. The renovations also anticipate that additional personnel will be required to staff a second manufacturing shift to meet the eventual market demand for Multikine. Following an $11 million investment to increase production, CEL-SCI staff recently moved back into the renovated facility.
“We are now validating the facility and will begin preparing our facility license application for Multikine. We continue to hire and train additional personnel required to efficiently operate the manufacturing facility in compliance with all federal and state requirements,” stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported topline results in June 2021 from its landmark pivotal Phase 3 study of Multikine as a neoadjuvant treatment of advanced primary previously untreated head and neck cancer, which is believed to be the largest study in the world for this indication.
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