ImmunityBio announced that the drug substance DS has been completed and successfully qualified for “fill finish” , sufficient for 170,000 doses of 400mcg ANKTIVA … Coupled with the recent announcement of a partnership with the Serum Institute of India (SII) for BCG availability, this provides the Company with a significant initial supply of ANKTIVA for commercial and clinical trial use in advance of the full operation of the Company’s own drug substance and fill-finish manufacturing plants in California and New York…Since the Company’s merger with NantKwest in 2021, ImmunityBio has made significant capital investments in personnel, plants, and equipment to ensure global capacity of ANKTIVA drug product for both the commercial launch, as well as clinical trials in bladder cancer and other tumor types in its pipeline. Both drug substance DS and drug product DP facilities are nearing completion to ensure sufficient capacity and multiple GMP manufacturing sites for ANKTIVA in its approved indication, as well as for clinical trials and future indications.
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