FDA’s Position Paper on Distributed Manufacturing and Point-of-Care Manufacturing
Throughout literature and movies, there is a trope that sufficient strife will produce sufficient innovations to overcome it. Within genres such as sci-fi or fantasy, this commonly manifests as new technology or techniques which exceed previous possibilities. Primary examples of this trope are the time machines from Terminator and hover-ship technology in The Matrix. Despite their prominence, unless necessary for the plot, the origin of these set pieces is rarely explained. Even so, reason dictates that these had to be invented or discovered by those with the initiative and responsibility to overcome disruption.
When applying this logic to reality, the disruption created by the Covid-19 pandemic provides an ideal situation for such innovations to sprout. To foster manufacturing innovation, the FDA has launched initiatives meant to spur the development of such solutions. The specifics of one such initiative in this ongoing process is explored in FDA’s paper Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.
FDA Encourages Manufacturing Innovation
In 2014, the FDA’s Center for Drug Evaluation and Research (CDER) established the Emerging Technology Program (ETP). ETP’s primary purpose is to support industry members in the implementation and creation of Advanced Manufacturing Techniques. These are manufacturing techniques which utilize contemporary pharmaceutical technologies and procedures to improve the supply chain’s reliability. These can be produced by inventively repurposing existing techniques, applying production methods in areas which they were not considered for before, or simply implementing unforeseen technological capabilities. With the wide scope of Advanced Manufacturing Techniques, research is being conducted into their use for both large and small molecule drugs.
Through this effort, CDER recognized the need for evolved regulations and policies that encourage the adoption and implementation of such innovations. To allow for expedited deployment, CDER is considering potential applications such as modular drug manufacturing, development, and deployment through the use of portable manufacturing units. This process, known as Distributed Manufacturing, would result in a decentralized manufacturing scheme composed of a network of production units. These units could be mobilized and sent to optimal locations for patient care, also known as Point-of-Care Manufacturing.
To this end, the ETP has interfaced with drug manufacturers to encourage the adoption of Advance Manufacturing solutions, including distributed manufacturing platforms.
Although it would be convenient for reality to manifest the solutions for our predicaments, it is through actions such as the FDA’s ETP which these advancements originate. Through their efforts, it could be possible for our pharmaceutical landscape to shift from a highly centralized and rigid grid to a more adaptive and reliable deployment network. This network, reinforced by Advanced Manufacturing Techniques, would allow healthcare providers to specialize their care to the needs of the community they serve. In turn, patient outcomes would improve with the greater availability of necessary drugs.
Therefore, history will look back at our great strife and appreciate the great toils required to achieve greater solutions to prevent and overcome dire situations.
We will continue to provide updates on FDA’s Advanced Manufacturing initiative as they become available.
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