BioCentury
ARTICLE | Product R&D

Academia’s manufacturing problem

How gene therapy manufacturing bottlenecks are impeding academic translation

September 14, 2018 2:37 AM UTC

With backups at academic manufacturing centers beginning to hamper translation of early stage gene therapies, pushing those who can afford it to CMOs, at least one non-profit has stepped in with a model to deliver the services on the cheap. But without more, the field may be slow to benefit from the next generation of gene therapies coming through.

Gene therapies are notorious for scale up issues that can hinder late stage trials or commercialization. However, manufacturing difficulties also extend to preclinical development, in particular in the transition from animal proof of concept to IND-enabling studies. The former does not require GMP-like vector, but the latter does. ...