1. Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice;Published,2017
2. Spark Therapeutics. FDA Approves Spark Therapeutics’ LUXTURNA™ (voretigene neparvovec-rzyl), a One-time Gene Therapy for Patients with Confirmed Biallelic RPE65 Mutation-associated Retinal Dystrophy. http://ir.sparktx.com/news-releases/news-release-details/fda-approves-spark-therapeutics-luxturnatm-voretigene-neparvovec. (Archived by WebCite® at http://www.webcitation.org/73nSoMzfQ). Accessed May 21, 2018.
3. Dendreon, done in by expensive, complex manufacturing, files for bankruptcy;Palmer;FiercePharma,2014
4. Triumph of the lean production system;Krafcik;Sloan Manage Rev,1988
5. Bulk production of monoclonal antibodies in fermenters;Birch;Trends Biotechnol,1985