Phage Biotechnology operates the site and will produce FGF-1 for CVBT’s development programs.
CardioVascular BioTherapeutics (CVBT) reports that the San Diego facility is using for production of one of its drugs received a California Food and Drug Board license to manufacture pharmaceuticals for clinical and commercial use.
The plant is operated by CVBT’s manufacturing partner, Phage Biotechnology. Phage produces all the human fibroblast growth factor-1 (FGF-1) that CVBT utilizes in its prelinical and clinical development programs.
The clinical lot of FGF-1 which will be used in CVBT’s upcoming Phase II trial in no-option heart patients was the focus of the inspection. Over 400 documents relating to the GMP production of the FGF-1 lot were inspected as well as the plant’s manufacturing equipment and its air and water systems.