The report was released under the title Bold Goals for US Biotechnology and Biomanufacturing and covers a diverse number of industries and national concerns for the country.
Within the report, the government outlined how it plans to use a focus on biotechnology and biomanufacturing to find solutions and opportunities in climate change, food and agriculture, supply chain resilience, ‘cross-cutting advances’, and human health.
On the latter priority, the report stated, “To prevail in the fight against disease and strive toward healthy living, several emerging fields in biotechnology and biomanufacturing need to be strengthened and developed further. In taking these key steps, the US government, in collaboration with the private sector, can advance areas throughout the full health continuum – from prevention to diagnosis and monitoring, to more efficient therapeutic manufacturing, to therapy and ultimately healthy survivorship.”
In terms of how this can be achieved, the report broke the government’s goals down into five sections, which included providing accessible health monitoring, precision multi-omic medicine, biomanufacturing of cell-based therapies, AI-driven bioproduction of therapeutics, and advanced techniques in gene editing. The objectives all have different timelines in terms of when they should be met.
The US government recognizes the potential of AI to speed up the production of both drug discovery and production, following a similar trend witnessed across the industry.
On AI, the US government wants to leverage a national network of resource labs to address barriers in autonomous production and bioproduction of existing biotherapeutics. In five years, it aims for the manufacturing speed of the ten most commonly prescribed therapeutics to be increased 10-fold. As part of its 20-year goal, the report outlined that the aim is for drug discovery and the production of all biotherapeutics to be increased 10-fold.
Cell therapies
On cell therapies, the report aims for the technologies that develop cell therapies to achieve 75% cell viability in patients in five years. In 20 years, the plan is for expanded access to the treatments and to decrease the manufacturing cost of cell-based therapies 10-fold.
For gene therapies, the plan is to produce at least five million doses of therapeutic gene-editing systems annually, within 20 years. According to the report, the government will also look to improve clinical infrastructure by installing necessary equipment to receive, store, and prepare gene therapies.
Beyond this goal, the report also states that to increase manufacturing capacity it will be necessary to ‘address gaps’ in the current landscape of contract research organizations (CROs) and contract manufacturing organizations (CMOs). Specifically, this will involve engaging with CROs to assess current capabilities and look to expand them further.
