Cytheris IL-7 (CYT107) is a fully glycosylated recombinant protein produced by a recombinant CHO strain designed and prepared by Cytheris. Process design and analytical controls have been performed by the Cytheris team in our laboratories in Paris followed by transfer and scale-up at Laureate Pharma, a CMO located in Princeton, New Jersey that provides cGMP services in an FDA approved facility
The cell banks and clinical batches have been prepared according to cGMP standards and fully validated for viral safety. In its current formulation the product has been approved for clinical trials by the U.S., Canadian, Italian and French Regulatory Authorities.