On Demand Pharmaceuticals Commissions State-of-the-Art, cGMP Medicine Manufacturing Facility
The cGMP facility represents a critical first step in a new era of drug manufacturing aimed at strengthening domestic supply chain resiliency
On Demand Pharmaceuticals, Inc. (ODP), an innovative technology company transforming the way medicines are made, announced today the opening of its current Good Manufacturing Process (cGMP) compliant manufacturing facility dedicated to manufacturing all aspects of the medicine supply chain, from fine chemicals to final drug product. The new facility adds to the growing biotech hub in Montgomery County, providing additional job opportunities while accelerating the U.S.’ effort to mitigate drug shortages amid the ongoing supply chain crisis.
Congressman Jamie Raskin (MD-08) provided opening remarks to a delegation of support at the official ribbon-cutting event on February 15th. Senator Ben Cardin (D-Md.) provided a virtual message of support. The facility’s opening comes as the U.S. Government looks to continue investing in new capabilities like ODP’s breakthrough manufacturing technology platform, the Pharmacy on Demand (PoD)™, to mitigate drug shortages during peacetime and crises and reduce U.S. dependence on foreign manufacturers.
Congressman Raskin, who represents Maryland’s 8th District and the site of ODP’s new facility, said: “On Demand Pharmaceuticals has come up with a remarkable invention and innovation that could become an historic game-changer for the production and distribution of pharmaceuticals to our people. A durable and resilient medicine supply chain is essential to strengthening America’s public health system, and I am proud that Maryland’s 8th district is the headquarters of a new era of medicine manufacturing led by pioneer companies like ODP.”
“The United States must make investments now to mitigate and prevent drug shortages in the future. Covid-19 has made all too clear the consequences when we do not,” said Senator Cardin. “I am so pleased the first medicines to be produced here [at ODP] are critical care medicines currently experiencing shortages.”
Mrs. Nikki Bratcher-Bowman, the Principal Deputy Assistant Secretary for Preparedness and Response and Chief Operating Officer said: “I want to ensure that the medical supply chain is resilient and can support our country’s needs. ASPR will continue to steward efforts to expand the domestic industrial base including investment in new manufacturing capabilities.”
ODP’s PoDTM offers a rapid response capability that can be quickly customized to produce anything from key starting materials to active pharmaceutical ingredients (API) and final formulated drugs. ODP is spearheading the development of automated and deployable PoD machines that will ultimately help ensure Americans have a secure supply of essential medicines whenever and wherever medicines are needed.
“Increasing American manufacturing supply chain resilience is crucial to the health and safety of all Americans,” said Congressman Tim Ryan, Vice Chair of Defense Appropriations, and the Chair of the House Manufacturing Caucus. “The COVID Pandemic has motivated us to renew our commitment to winning back the global economy and I commend On Demand Pharmaceuticals for providing the innovation we need to stay ahead of our competition.”
The foundational PoD technology was developed with funding from the Defense Advanced Research Projects Agency (DARPA) under the Battlefield Medicine program. DARPA then funded ODP in the Make-It program to build out this technology and demonstrate its ability to produce a single solid dosage medicine that met regulatory standards. In response to critical pharmaceutical supply chain disruptions during the pandemic, DARPA and HHS ASPR funded ODP through the 2020 CARES Act to build a suite of new capabilities, including the ability to produce injectable medicines and their critical precursors.
“DARPA’s investments in such foundational technologies through our Battlefield Medicine and Make-It programs have enabled revolutionary capabilities for pharmaceutical manufacturing,” said Dr. Stefanie Tompkins, DARPA’s director. “This new facility and continuing advances in this technology space are key to ensuring resilient and responsive domestic production of critical medicines and other chemical products.”
The new facility will support production of critical care medicines in preparation for the upcoming regulatory filings.
About On Demand Pharmaceuticals
About On Demand Pharmaceuticals
On Demand Pharmaceuticals™ is an innovative technology company transforming how medicines are made so they can be produced on demand—whenever and wherever medicines are needed. Our breakthrough manufacturing technology platform, the Pharmacy on Demand (PoD)™, can be quickly customized to produce anything from key starting materials to active pharmaceutical ingredients (API) and final formulated drugs and was recently named by the World Economic Forum and published in Scientific American as one of the top 10 emerging technologies of 2021. With this technology, we’re on a mission to provide an adequate, safe, and reliable supply of medicines to every community across the world.