Cell and gene therapy manufacturing: Scaling the next frontier
Cell and gene therapies have moved from scientific promise to commercial reality, but manufacturing remains the field’s biggest bottleneck. CDMOs have struggled with overcapacity and funding shortfalls — AmplifyBio and Exothera shut down, while Thermo Fisher cut hundreds of viral vector jobs. At the same time, new players like Mytos and BioNexus are entering the space, and the FDA has eased manufacturing rules to help scale individualized therapies. Tariff pressures are pushing pharma to rethink global supply chains, with Lonza, Roche, and Samsung Bio expanding US-based capacity. Endpoints tracks cell and gene therapy manufacturing from CDMO consolidation to regulatory shifts and facility investments.
Top Stories
- FDA shares ‘more flexible approach’ to overseeing cell and gene therapy manufacturing
- Cell and gene therapy CDMO AmplifyBio shuts down over 'scarcity' of funding
- Cell therapy CDMO Mytos unveils its first facility in the UK
- New CDMO emerges, acquires cell and gene manufacturer Landmark Bio
- Thermo Fisher to lay off 300 workers at two viral vector factories
Additional Topics
- WuXi AppTec sues Pentagon in challenge over inclusion on Chinese military list
- Drugmakers are turning to logistics providers as trade disruptions linger, DHL exec says
- Camurus’ second CRL for acromegaly drug; Teva details workforce cuts
- Neion Bio lands $23M Series A to make proteins from chicken eggs
- SonoThera raises $125M for non-viral gene therapy approach
Featured Articles
- A father built a gene therapy for his daughter. He says an FDA request is the bottleneck
- WuXi AppTec added to Pentagon's list of companies linked to Chinese military
- Pfizer's good-enough obesity data in a crowded market may force competition on price, dosing
- Corrected: Mammalian hair, roof leaks: Novo Nordisk's site in Indiana under FDA scrutiny once again
- Hikma to funnel $267M to Ohio; Cingulate gets CRL for ADHD drug
Conclusion
This article outlines the current state of cell and gene therapy manufacturing, highlighting both challenges and advancements in the field.