Biogenera è lieta di annunciare un nuovo e strategico accordo di collaborazione con Diatheva, Società biotecnologica italiana con sede a Fano (PU), specializzata nella produzione di principi attivi biologici e nello sviluppo di processi in GMP (Good Manufacturing Practice). L’accordo riguarda l’inizio dell’attività di Fill & Finish (infialamento) del nostro farmaco antitumorale BGA002, primo candidato anti-gene sviluppato per il trattamento di tumori aggressivi legati al gene MYCN.
Diatheva, acting as a Contract Development and Manufacturing Organization (CDMO), has extensive experience in the development and production of biotechnological products for clinical and commercial use. Its GMP capabilities, combined with strong expertise in the field of advanced therapies, ensure high standards of quality, safety, and efficiency in the crucial phase preceding the start of clinical trials.
Thanks to this collaboration, Biogenera takes another important step towards initiating the Phase I clinical trial on pediatric patients affected by MYCN-altered tumors. The Fill & Finish activity represents one of the final steps in the drug manufacturing process, essential to ensure the stability, sterility, and traceability of the batches intended for clinical administration.
“We are proud to collaborate with an outstanding Italian partner like Diatheva. This agreement allows us to further strengthen our production pipeline and brings us closer to the first clinical administration of our drug”
said Massimiliano Cesarini, CEO of Biogenera
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