Between 2012 and 2014, the US Federal Government spent $2.9bn (€2.6bn) in developing techniques and technologies for the production of cell and gene therapies, according to a White House report on the state of US manufacturing published this week.
But while there has been a steady increase in funding to demonstrate the possibility of such biological products, there remains “a critical and growing need to focus on process engineering to achieve manufacturing reproducibility to increase the reach of the emerging therapeutics,” the report from the Subcommittee for Advanced Manufacturing of the National Science and Technology Council said.
Among the problems cited is the underdevelopment of appropriate growth media for cells, limiting the necessary scale to assure consistency of product:
“Current systems are too inefficient for suspension-grown cells, largely non-existent for adherent cells, and patient-specific for engineered tissue. Research on efficient, safe production of cells and engineered tissues at commercial scale is required to ensure that these precision therapies will be economically and technically achievable.”
The report acknowledges that making cell and tissue products is more challenging than manufacturing biologics due to the largely undefined manufacturing release criteria, the complexity of the product, and the very short shelf-lives of such products, but says the sector should still take lessons from the “traditional” biopharmaceutical industry in terms of how to control its manufacturing products and processes.
“For example, regenerative medicine and pharmaceuticals share some conceptual challenges including bioreactor control, continuous manufacturing, scale-up of cell culture, distributed manufacturing of small personalized batch therapies, starting materials, and the use of disposables in manufacturing.”
It also suggests investing in continuous manufacturing could aid cell and gene therapy production, as well as bioproduction as a whole.
“Although each cell and tissue product is fundamentally unique, their bespoke manufacturing processes may follow a common process governance structure where manufacturing activity is quantified, standardized, and monitored.”
Future investment
The Federal Government, therefore, is set to support the future of regenerative medicine through the development of generalizable approaches to common manufacturing design, development, scale-up, and scale-out challenges.
“This may make the technology attractive enough for the pharmaceutical industry to adopt and use to develop a new class of therapeutics.”
Some of the Government’s current investments in biomanufacturing for regenerative medicine are displayed below: