Commercializing cell and gene therapies is a major problem for manufacturers, even if their products have proven successful in clinical studies. For companies whose therapies do make it to the market, recouping investments can be challenging, given that payers and health care systems often question the high prices associated with advanced therapy medicinal products (ATMPs).
ATMP Manufacturing: Complex Challenges Require Complex Solutions
Demand for ATMPs could outstrip supply by tenfold within the next three years unless companies find ways to scale up production.
Experts working in the advanced therapy sector tell In Vivo how novel solutions can empower cell and gene therapy manufacturers to reduce costs, improve scalability and optimize their processes – improving the clinical profile and commercial viability of products.

More from Manufacturing Focus
Rentschler Biopharma CEO Benedikt von Braunmühl tells In Vivo about the CDMO's strategic decision to exit the cell and gene therapy manufacturing space.
The Centre for Commercialization of Regenerative Medicine has spent over a decade crafting a cell and gene therapy ecosystem in Canada. Now it is replicating the model abroad.
Artiva Biotherapeutics is hoping its NK cell therapy approach, which uses un-engineered cells, will prove effective in both oncologic and autoimmune indications and safe enough to be given in the community setting.
Pharmaceutical manufacturing is developing at a lightning pace as the confluence of automation and AI creates opportunities for much higher efficiency and throughput. Experts from across the industry discuss these, and the challenges around implementation and standardization.
More from Outlook
Pressure to exploit connected care functionality is accelerating the shift in care delivery away from the inpatient setting. Medtechs are reshaping to maximize faster-growth opportunities.
Nine biopharma companies made 12 or more deals, with Novartis inking 21 deals and leading M&A activity. Roche, meanwhile, spent little up front but maintained a hectic pace with 12 alliances.
As Eli Lilly and Novo Nordisk reap the blockbuster rewards of their rival obesity therapies the companies are also bulking up their organizations to make the most of the phenomenal rise of the GLP-1 class.