Manufacturing and Infrastructure Building
Ensuring the availability of medical countermeasures for public health emergencies is central to BARDA's mission. This includes ensuring that manufacturing infrastructure is sufficient to support the production of required products, in a manner that is timely, reliable and cost effective.
BARDA is taking several approaches to bringing online the necessary infrastructure for medical countermeasure manufacturing. We are supporting the construction of new facilities as well as retrofitting existing facilities for maximal capacity and flexibility. We are also exploring the use of multiproduct manufacturing facilities to provide flexibility and surge capacity. So that we are able to rapidly provide countermeasures in the dosage forms required for use in the field, we are establishing a network of formulation/fill-finish manufacturers for emergency production and distribution. BARDA is also exploring the creation of centers of excellence for the development and production of non-commercial products, with assistance from industry partners.
Centers for Innovation in Advanced Development and Manufacturing
The Centers for Innovation in Advanced Development and Manufacturing will support the country's advanced development activities for CBRN-related products, and HHS, with U.S. Government partners, including BARDA, will provide guidance and management oversight in terms of specific product objectives. Different capabilities, and perhaps different centers, will be needed to span the known and future technological diversity for making biologics, vaccines, drugs, and diagnostic devices. Finally, in public health emergencies, these Centers may augment existing United States manufacturing surge capacity against emerging infectious diseases or unknown threats, including pandemic influenza.
The envisioned result is an integrated, domestic infrastructure
based on strategic partnerships with industry and/or academia with
unprecedented flexible and modular capabilities to develop and
manufacture new biological MCMs in a timely manner to protect the
U.S. civilian population. The Centers will help to support and
develop the next generation of the MCM development workforce
through training opportunities, including graduate training
programs, for current and future industry and government scientists
who engage in advanced development and manufacturing of MCMs. The
Centers will also be used to explore emerging and innovative
technologies that could be applied to current or future MCM
development efforts to reduce risk, increase yield, and ultimately
to reduce total life-cycle costs through flexible manufacturing,
consolidating other costly product development expenditures, or any
other economy-of-scale opportunities potentially created by these
Centers.
The Public Health Emergency Medical Countermeasures
Enterprise Review (Aug 2010)
BARDA Partners to Build First U.S. Manufacturing Facility for Cell-Based Influenza Vaccine
On January 15, 2009, BARDA awarded a $487 million multiple year contract with Novartis Vaccines and Diagnostics, Inc., to build the first U.S. facility to manufacture cell-based vaccine for seasonal and pandemic flu. Because cell-based influenza vaccine can be made faster and in greater quantities than traditional vaccine, the new facility is expected to increase the U.S. capacity to make pandemic influenza vaccine by at least 25 percent.
Cell-based vaccine production could more easily meet surge capacity needs because cells could be frozen and stored in advance of an epidemic or developed rapidly in response to an epidemic. Cell-based vaccine production also dramatically reduces the possibility for contamination and promises to be more reliable, flexible, and expandable than egg-based methods.
