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DSO’s Make-It program on Synthetic chemistry enables end-to-end automated production of pharmaceuticals and other chemicals

Chemists who are trained in synthesis use their skills to create new forms of matter. They synthesize compounds not just because they are new: the design and preparation of these new compounds leads to numerous applications in pharmaceuticals, materials, detection, energy utilization and storage, and insights into biological systems. Synthesis of new catalysts is used to find more efficient ways to mass-produce the compounds that support our standard of living, and to prepare new variants that could not previously be imagined.

 

Synthetic chemistry spans the fields of organic, inorganic, materials, and even biological sciences. Chemical synthesis leverages the fundamental reactivity of the elements to construct increasingly complex molecular architectures through the purposeful execution of chemical reactions.

 

Chemists also conduct and advise on research having military and/or medical application, such as protection of personnel from chemical, biological, and radiological agents; development, handling, and use of improved petroleum and synthetic fuels and lubricants; and, purification and control of atmosphere, as on nuclear submarines. Chemists also perform experiments, devise instrumentation and techniques to record and collect test results, correlate and analyze data compiled in research, and brief results.

 

Yale’s program in synthetic chemistry spans from the tethering of biomolecules together, to the preparation of natural products, to the creation of metal complexes in new environments.

 

The U.S. relies heavily on pharmaceutical production in China and India, which as the COVID-19 outbreak is demonstrating, creates a fragile supply chain over which we have little control.DSO’s  Make-It has laid the groundwork for a resilient, responsive, and adaptive U.S.-based pharmaceutical manufacturing capacity that can be centralized or distributed and adjusted on demand based on critical need.

 

DSO’s Make-It program making decentralized pharmaceutical production possible

Imagine a scenario where a clinical trial has proven that an existing drug has anti-viral properties that could help end a pandemic. Then imagine that drug is only made in a foreign country whose workforce has been decimated by the virus that causes the pandemic. Supply chain problems make it impossible to meet worldwide demand for the drug. Rather than waiting critical months to ramp up alternative production capabilities, what if you could provide the recipe for the drug to preexisting, small manufacturing platforms located around the globe that could make required doses of the drug immediately at the point of need?

 

DSO’s Make-It program is developing such a capability. Make-It enables end-to-end automated production of pharmaceuticals and other chemicals in small-scale, modular, continuous manufacturing platforms. These technologies enable a paradigm shift from inflexible, large-scale batch production in centralized facilities to production on-demand at the point of need.

 

Make-It has demonstrated capability for hands-free production of more than 35 active pharmaceutical ingredients (APIs) on flexible, modular hardware; AI-based computational methods to design synthetic routes (i.e., recipes) for known and new APIs; and the ability to produce select medicines in final formulated pill form. Make-It capabilities were inspired by the DARPA Battlefield Medicine program, which created manually reconfigurable production devices intended to support military readiness in farforward deployed settings. While these applications are still a focus of Make-It, the fully automated suite of technologies developed in the program have demonstrated value across the chemical supply chain, improving reproducibility, safety, supply, and reliability and enabling flexible, scalable response to dynamic demand on a single, fully automated production system.

 

Such a capability could 1) ensure continuous delivery of critical medicines in the event of an external supply disruption (a known vulnerability for large manufacturing facilities), 2) enable rapid adaptation of a single production device to respond to many pharmaceutical targets, and 3) provide robust, validated in-line analytics and process control to ensure the quality of API or medicines produced at all times.

 

DARPA is currently working with the Department of Health and Human Services’ Assistant Secretary for Preparedness and Response (ASPR) to demonstrate production of a generic antibiotic in final pill form (Ciprofloxacin) for approval by the Food and Drug Administration (FDA), a critical step to enable Make-It’s vision for pharmaceutical production. This effort is currently in a pre-Good Manufacturing Process (GMP) development phase and scheduled to culminate in submission of an Abbreviated New Drug Application (ANDA) to the FDA in early 2022. While this step is critical to fully realize these production systems for final pharmaceutical applications (e.g., pills/injectables), the API synthesis capabilities are robust and well demonstrated. These devices could be developed in the near-term to demonstrate capacity for U.S.-based production of APIs and rapidly respond to critical supply disruptions such as that caused by the COVID-19 pandemic.

 

 

 

 

 

 

About Rajesh Uppal

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