FDA Places Clinical Hold on Atara Biotherapeutics’ EBVALLO and ATA3219 Due to Manufacturing Compliance Issues

Atara Biotherapeutics, FDA clinical hold, EBVALLO, ATA3219, allogeneic T-cell therapies, manufacturing compliance issues, GMP compliance, Epstein-Barr virus, post-transplant lymphoproliferative disease, non-Hodgkin’s lymphoma, systemic lupus erythematosus.

Strategic Roadmap for Biologics Manufacturing: Enhancing Efficiency and Flexibility

Biologics manufacturing, Strategic roadmap, Process characterization, Flexibility and efficiency, Regulatory compliance, Biomanufacturing technology roadmap, Precision medicines, Modular facilities, Continuous manufacturing