CDMOs key to improving CGT efficiency and cutting costs

The complexity of producing advanced therapies and questions surrounding the scalability of such products continue to haunt the industry. The latest US approved product, Orchard Therapeutics’ metachromatic leukodystrophy (MLD) gene therapy Lenmeldy (atidarsagene autotemcel), has a wholesale acquisition cost of $4.25 million, again raising questions surrounding the accessibility of cell and gene therapies (CGTs).

The issue was therefore a major talking point at last week’s Advanced Therapy Congress in London, UK, with contract development and manufacturing organizations (CDMOs) – already an integral part of the CGT supply chain – explaining how they can help bring down costs.

“Cell and gene therapies are very expensive, not only for our clients but for patients too,” Jennifer Hayne, head of Strategic Marketing at CDMO ReciBioPharm told BioProcess Insider at the event. “It's up to us in the industry to think about and continue optimizing platforms where they do exist.”

Pieter-Jan Vos, director of BD, Europe for fellow-CDMO Batavia Biosciences held a similar view, telling us the service-side of the industry should be moving towards creating efficient platform technologies. “CDMOs should create efficient technology platforms to cut costs. And to bring the costs further down, the CDMOs should resort to using less material while creating higher titers in very quick time spent.”

Manuel Balbuena, director of BD, CGT for AGC Biologics, meanwhile, told us biopharma clients already expect CDMOs to be driving efficiencies, achieving high quality delivery of GMP material in a shorter time.

“The challenge for us today is increasing the speed from clinic to the market, while supporting GMP readiness.”

Michael Baker, senior director of vector gene therapy at Fujifilm Diosynth Biotechnologies, told delegates viral vector production is largely dependent on scalability and harvesting efficiency. Furthermore, he said the high costs of raw materials – somewhere between $1-2 million – is a key factor that limits production.

However, he highlighted three key areas of technological advancements that CDMOs can harness to help drive batch productivity and reduce the costs for patients:

“First are the facilities; improving the design and efficiency of facilities to focus on quality, getting into manufacturing quicker,” he told delegates during a presentation.

“This is followed by experience as the industry matures and grows – hopefully you'll start seeing core lessons as best practices. And lastly, mass production, which is the dream for the industry and a real challenge.”