–Multiple drug substances Produced in a Single Reconfigurable Device–
ROCKVILLE, Md., June 29, 2020 –On Demand Pharmaceuticals (ODP) announced new research demonstrating the ability to perform synthesis, isolation, and formulation of several drugs in a single reconfigurable device.
The COVID-19 pandemic has highlighted US vulnerabilities in manufacturing and supply chains. Today, 100% of generic medicines require part of its manufacture or formulation performed in a foreign country, including active pharmaceutical ingredients (APIs). Continuous pharmaceutical production in compact modules is a potential solution that allows for drug manufacturing when and where it is needed, with significantly shorter lead times. ODP effectively demonstrated this capability in a recent study utilizing their proprietary Pharmacy on Demand (PoD) units.
The study, Continuous Production of Five APIs in Flexible Plug-and-Play Modules – A Demonstration Campaign, was published in the American Chemical Society Publication Organic Process Research & Development. A new set of Pharmacy on Demand (PoD) refrigerator-sized modules were constructed to demonstrate the potential of running these systems end-to-end in an industrialized manner within a pre-determined manufacturing timeframe.
This research demonstrated the synthesis and formulation of USP-compliant tablets of diazepam, diphenhydramine hydrochloride and ciprofloxacin hydrochloride, as well as liquid formulations of lidocaine hydrochloride and atropine sulfate. These medicines are generic medications on the World Health Organization’s (WHO) list of essential medicines, and are also part of a field-surgeon’s toolkit.
Three automated PoD modules were designed, built and operated for this research. The PoD units produced 1000 doses of formulated, high quality API in 24 hours.
The research was led by Dr. Luke Rogers, ODP VP of Chemical Synthesis and Dr. Naomi Briggs, ODP VP of Drug Substance Purification, along with a team of outside collaborators from MIT and North Carolina A&T State University.
“This initiative seeks to develop miniaturized reconfigurable platforms that can rapidly produce multiple APIs in response to specific national health crisis’, battlefield threats, epidemic or pandemic situations, and natural disasters. The ability to rapidly manufacture high quality generic drugs will be a pharmaceutical game changer. This technology will truly provide personalized medicine, and enable the manufacture of drugs at the point of care,” stated Dr. Rogers.
“Our technology is the only complete beginning-to-end drug manufacturing solution. As the COVID-19 pandemic continues, multiple potential therapeutics are being investigated. Our rapid manufacture process can ensure an adequate supply of drugs under investigation,” added Dr. Briggs.
This work was supported by the Defense Advanced Research Project Agency (DARPA) and Space and Naval Warfare Systems Center Pacific (SSC Pacific) under Contract no. N66001-16-C-4005.
The article is available at: https://pubs.acs.org/doi/10.1021/acs.oprd.0c00208
On Demand Pharmaceuticals is an innovative pharmaceutical manufacturing company creating technology that will change the market dynamics by making medicine production more efficient. ODP is transforming pharmaceutical manufacture by increasing quality, reducing costs, and making a new business model for US production that will truly provide personalized medicine, and enable the manufacture of drugs at the point of care and in a specified strength and quantity. ODP is led by an experienced team of chemical engineers, materials science experts, pharmacists, pharmacologists, and organic chemists.