BARDA, the Biomedical Advanced Research and Development Authority, works with the pharma industry to manufacture medical countermeasures for stockpiling and response through several different initiatives.
“Most of our medical countermeasure (or MCMs) are produced using manufacturing techniques that are common throughout the industry,” Michael Angelastro, Deputy Director, BARDA’s Division of Manufacturing, Facilities, and Engineering, and Centers for Innovation in Advanced Development and Manufacturing (CIADM) Program Manager, told us.
Angelastro, who will be speaking at Interphex this year at that Javits Center in New York City, also explained that the organization is always actively engaging the industry to identify new approaches that enable the rapid, safe, and cost-effective development and manufacturing of MCMs.
In these efforts, BARDA works with the Centers for Disease Control and Prevention to have pharmaceutical or biopharmaceutical MCMs manufactured and pre-positioned within the Strategic National Stockpile (SNS) for rapid deployment.
“Those MCMs are accessed through a request from the impacted state or are released by the SNS collaborating with states in a national emergency,” explained Angelastro.
For influenza strains of pandemic potential, specifically, BARDA purchases and stockpiles bulk vaccine that can be quickly filled into vials or syringes and packaged at the onset of a public health emergency.
Other MCMs are manufactured by the pharmaceutical industry and sold on the commercial market for other indications and, therefore, are available via pharmacies in addition to the SNS.
Manufacturing medical countermeasures
According to Angelastro, it is not cost-effective to have idle commercial-scale surge capacity for “just-in-time” MCM production.
Thus, in order to have access to technologies and capabilities to rapidly scale-up and manufacture products in time to respond to large-scale emergencies, and to provide surge capacity, BARDA established three Centers for Innovation in Advanced Development and Manufacturing (CIADMs) in 2012. The centers were the first major US infrastructure to address biodefense threats and pandemic influenza.
Today, the CIADM program is approaching the four-year mark of its “establishment phase.” Angelastro explained that “all three CIADMs are progressing well in completing construction work and demonstrating capabilities.”
However, over the last two-plus years the facilities had to be activated to assist in the “whole of government” response to avian influenza, Ebola virus, and currently, Zika virus outbreaks.
Additionally, “to address one of many lessons learned from the 2009 H1N1 Influenza Pandemic, BARDA established a Fill & Finish Manufacturing Network,” explained Angelastro, as “the need and public demand for vaccine during H1N1 outpaced pharmaceutical companies’ capacity for that critical downstream operation.”
This network has since become one of the of the BARDA’s core services, which is able to support the organization’s industry partners in filling and finishing MCMs for use in a clinical setting, as well as for distribution in a national emergency.
“Because the CIADMs and the Fill & Finish Manufacturing Network are prepositioning and leveraging technologies that create surge capability, BARDA considers them a key part of our National MCM Response Infrastructure,” added Angelastro.
The CIADMs will also be able to provide a full suite of Contract Manufacturing Organization (CMO)-type services to product developers or to BARDA on a product developer’s behalf.
“Innovative approaches to the development and manufacture of MCMs is a key objective of the CIADMs, as the name of the program implies,” said Angelastro. “The industry has seen great progress in the acceptance of single-use equipment, continuous manufacturing, and platform technologies.”
BARDA’s program initiatives
Since the agency’s inception in 2006, BARDA has supported the research and development of more than 180 MCMs, work which included technical transfers, process and analytical testing development, and scale-up manufacturing – and a great deal of this work was supported by the CIADM and the Fill Finish Manufacturing Network.
One of BARDA’s latest priorities is a collaboration with the FDA to promote industry adoption of continuous manufacturing technologies.
“This is an area that BARDA believes has great promise for accelerating MCM manufacturing during emergencies and lowering end-to-end cost of goods,” said Angelastro.
Both the FDA and BARDA issued a Request for Information to survey the industry on continuous manufacturing technology.
Since issuing this RFI, both organization have updated their active Broad Agency Announcements (BAAs) on the Federal Business Opportunities site to reflect the Continuous Manufacturing Initiative.