BioCentury
ARTICLE | Product R&D

Gene therapy’s make or buy choice

How gene therapy companies are navigating manufacturing decisions

December 14, 2018 3:55 AM UTC

Whether or not to bring manufacturing in-house for gene therapy companies is becoming a critical choice, as contract manufacturers struggle to keep up with demand. The trade-off for the upfront investment risk is control over development timelines and the rapidly evolving science of process development.

A spate of gene therapies could hit the market in the next few years, following Spark Therapeutics Inc.’s Luxturna voretigene neparvovec, which last year became the first of the modality to gain FDA approval. At least one additional candidate is in registration -- Novartis AG’s Zolgensma onasemnogene abeparvovec -- and 14 others are in Phase III testing, according to BioCentury’s BCIQ database...