ASPR Announces Two Additional Defense Product Act Title III Active Pharmaceutical Ingredient Investments

According to a Nov. 25 press release, the Administration for Strategic Preparedness and Response (ASPR), part of the U.S. Department of Health and Human Services, announced two additional Defense Product Act (DPA) Title III Active Pharmaceutical Ingredient (API) investments focused on solving ongoing drug shortages.

The investments aim to “rebuild and protect the U.S. public health supply chain as an essential part of national defense.”

Further, “Under DPA Title III, ASPR's Office of Industrial Base Management and Supply Chain (IBMSC) will provide $32.4 million to Manus Bio, Inc., a private company in Waltham, Massachusetts, to expand its facilities for the production of key starting materials for essential medicines. Manus will utilize biomanufacturing and incorporate a continuous flow process which enables automated multi-step chemical synthesis. Manus has developed a suite of optimized microbial chassis which gives access to more than 150,000 natural products, known as bioalternatives, including terpenoids, polyketides, phenylpropanoids, and flavonoids.”

The release added that ASPR IBSMC is also going to provide up to $12 million to Antheia, Inc., a private pharmaceutical ingredient manufacturer located in Menlo Park, Calif. Antheia's biomanufacturing platform leverages bioengineering and computational biology to produce critical drug substances in an efficient and scalable one-step fermentation process. Antheia says it will focus on key starting materials and APIs used in the production of essential medicines.

“Both agreements include submitting data to the U.S. Food and Drug Administration (FDA), if needed by FDA when assessing drug applications from pharmaceutical manufacturers seeking to use Manus or Antheia as suppliers,” the release said.