BARDA, HHS to lead Biopharmaceutical Manufacturing Consortium Industry Day

As part of efforts to optimize both governmental and industrial approaches to medical countermeasure manufacturing, the U.S. Department of Health and Humans Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA) will host a Biopharmaceutical Manufacturing Consortium (BioMaC) Industry Day on Jan. 20, 2022.

The consortium will include industry partners from all levels of the drug and vaccine manufacturing supply chain. Therein, the government will attempt to lay the groundwork for creating an effective physical infrastructure that would allow for more effective and efficient responses to future pandemics. Domestic industry would play a key part in any future public health emergency response.

Because of this fact, the U.S. government seeks to maintain access to manufacturing capabilities for various components within the pharmaceutical industrial base and supply chain, lest they face similar issues to those that have plagued domestic response since the onset of the COVID-19 pandemic began closing borders. Going forward, HHS and BARDA will stress the necessity of elements down to tubing, filters, and other raw materials and ingredients used in vaccine production or critical drugs.

Presently, many of the active pharmaceutical ingredients (APIs) used in vaccine and drug production are made and shipped in from abroad.

The industry day will be an hour and a half long affair focused on MCM manufacturing and the role of public-private partnerships within a revised U.S. biomanufacturing infrastructure. It is a free event, during which the industry will be able to submit and address issues and roadblocks to navigating public health emergencies. This feedback, and that collected from an existing Request for Information BARDA issued in November 2021, will be used for market research to develop a potential program to partner BARDA with the industry in achieving governmental pandemic preparedness goals.

The consortium represents an expansion of the current National Biopharmaceutical Manufacturing Partnership, led by the BARDA Pharmaceuticals Countermeasure Infrastructure division.