The API threat
The COVID-19 pandemic has exposed how dependent the U.S. is on overseas pharmaceutical supply chains. Over 80% of active pharmaceutical ingredients (APIs) and chemical ingredients used in the U.S. to manufacture generic and over-the-counter drugs are produced elsewhere, primarily in China and India. This reliance developed over the last 20 years as economic and regulatory factors motivated U.S. companies to move operations overseas.
But international pharmaceutical manufacturing processes often use traditional, slow processes. Shipping ingredients or finished drugs overseas also delays the availability of essential medications during global health emergencies. This places the U.S. national medical supply at risk when individual countries can close borders and potentially eliminate access to critical materials.
Establishing advanced biomanufacturing in the U.S.
Under the new HHS plan, drug ingredients will be manufactured at facilities in the U.S., including a new facility to be built in Virginia. To lower production costs and increase quality, safety, and volume of medicines, the project will use advanced manufacturing processes, including "flow" chemistry and other continuous manufacturing techniques.
Along with strategic partners, Phlow has begun manufacturing APIs and finished dosage forms for over a dozen essential medicines to treat hospitalized patients with COVID-19. The award has allowed Phlow and its partners to deliver over 1.6 million doses of five generic medicines used to treat COVID-19 to the U.S. Strategic National Stockpile. Many of these medicines are in shortage and have previously been imported from foreign countries.
The total contract value of the award is $812 million -- provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS -- and includes a four-year base of $354 million with an additional $458 million as potential options for long-term sustainability.
Phlow is also building the first Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) in the U.S. with the goal of developing a long-term, national stockpile to secure key ingredients to manufacture the most essential medicines in the U.S., thereby reducing the dependence of the U.S. on other nations to support its drug supply chain.
Strategic U.S. Partners
"BARDA is committed to working with partners from the private sector and across the U.S. government to improve our nation's health security," said Gary Disbrow, PhD, BARDA acting director, in a statement. "Utilizing advanced manufacturing processes increases the speed we can provide patients with treatments, reduces the likelihood of drug shortages, and increases U.S. readiness. Today we have taken an important step to strengthen our domestic drug production capability and respond to the increased need for medicines to treat COVID-19 patients during the current pandemic."
Phlow will carry out the mission of securing the national supply of essential medicines through partnerships with pharmaceutical supply and manufacturing organizations, including AMPAC Fine Chemicals, Civica Rx, and the Medicines for All Institute at the Virginia Commonwealth University College of Engineering.
AMPAC is a custom API manufacturer with three U.S.-based facilities for high-throughput, commercial good manufacturing practices (cGMP) production. The company is working with Phlow to build an advanced manufacturing capability in Virginia, as well as sterile injectables manufacturing facilities.
Civica Rx is a nonprofit generic pharmaceutical company that will maintain a reserve inventory for many of the drugs produced by the partnership, including vancomycin, ketamine, lidocaine, fentanyl, and morphine.
The Medicines for All Institute is also a nonprofit organization dedicated to advancing drug manufacturing processes. Phlow partners with Virginia Commonwealth University with the goal of providing affordable, high-quality, and U.S.-manufactured medicines to patients.
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