Features
Presenters and a panel of FDA regulators and industry experts discussed key regulatory and industry issues during the closing plenary of the 2019 ISPE Biopharmaceutical Manufacturing...
Cell & Gene Therapy
Features
Innovations in production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply were the focus of presentations at the 2019 ISPE Biopharmaceutical...
Features
The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10–12 December in Huntington Beach, California, provided information about future-oriented developments in the burgeoning area of biopharmaceutical manufacturing—and also shared insights into the achievements...
Features
On 30 August, the US Food and Drug Administration (FDA) approved Novartis's Kymriah (tisagenlecleucel, CTL019), the first gene therapy for the treatment of pediatric and young-adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Kymriah belongs to a class of drugs called chimeric antigen receptor (CAR) T-cell therapies, which constitute a form of immunotherapy...