Course of validation in cell and gene remedy growth is advanced and stuffed with uncertainty. On this comparatively untested area, figuring out and using one of the best practices to advance a remedy from idea to market can really feel inconceivable – however it doesn’t should be!
Lenmedly™, a hematopoietic stem cell (HSC) gene remedy from Orchard Therapeutics, is the primary gene remedy to realize FDA and EMA approval for remedy of metachromatic leukodystrophy (MLD).
AGC Biologics’ skilled Cell and Gene CDMO group in Milan offered end-to-end help for the drug product by growth, medical levels, CMC technique, and commercialization within the context of regulatory approval.
We’ll stroll by the method our main group makes use of to supply lentiviral vector-based merchandise that may scale at any stage and meet rigorous regulatory calls for.
