The U.S. Food and Drug Administration has cleared AGC Biologics’ Milan site to begin manufacturing of Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel), a gene therapy for early-onset metachromatic leukodystrophy (MLD).
CDMO AGC Biologics will produce Tzield (teplizumab-mzwv), a recently-approved T1D treatment from Provention Bio, at its Seattle protein biologics manufacturing site.
AGC Biologics and RoosterBio have launched a strategic partnership to create an end-to-end solution for the development and production of hMSC and exosome therapeutics.
AGC Biologics will add viral vector suspension technology and capacity for the development and manufacturing of gene therapies at its commercial-grade campus in Longmont, Colorado.
CDMO AGC Biologics has acquired a commercial manufacturing facility in Longmont, Colorado: giving it significant additional capacity and space to expand its global end-to-end cell and gene therapy offering.