Cell and gene therapy makers have suffered manufacturing setbacks, but experts working in the supply chain say ensuring high quality raw material is the key to success. Manufacturing issues have plagued the few advanced therapies to have made it to the market. Dendreon’s Provenge (sipuleucel-T) suffered from high complexity of manufacturing and administration, Novartis’ Kymriah (tisagenlecleucel) saw some variability in its product specifications, and – most recently – Bluebird Bio has been accused of lacking manufacturing readiness for its recently…

BIA Separations’ prepacked chromatography columns “contribute to a robust manufacturing process” for the recently approved gene therapy Zolgensma, says AveXis. In May, the US Food and Drug Administration (FDA) approved Zolgensma (onasemnogene abeparvovec), a gene therapy designed to halt progressive spinal muscular atrophy (SMA). Novartis subsidiary AveXis developed and commercialized the $2.1 million one-off treatment, but – as the saying goes – it takes a village to raise a child. Zolgensma relies on Regenxbio’s adeno-associated virus (AAV) vector technology, and…

Avalon GloboCare has teamed with GE Healthcare to establish automated and standardized cell production capabilities to support its cellular immunotherapy programs. Under terms of the deal, clinical stage biotech Avalon will access bioprocess vendor GE Healthcare’s FlexFactory Cell Therapy platform to develop a production infrastructure for its pipeline of Chimeric Antigen Receptor (CAR) T cells and other immune-effector cells for cellular immunotherapy. Avalon will also gain access to GE’s FastTrak process development and training services, as well as its extensive…