The U.S. government encourages the expansion of domestic production capacity for single-use vaccine and drug production systems

The U.
S.
Biomedical Advanced Research and Development Agency (BARDA) awarded FlexBiosys of Lebanon, New Jersey a $14.
5 million contract on September 30.
The supplier will use the funds to expand its manufacturing plant to "provide new crown and cooperation Epidemic-related disposable products provide enhanced domestic manufacturing capabilities
.

” On October 7, BARDA announced a request for government funding to expand domestic production of disposable bags, pipes, and related components to support the new crown vaccine in a public health emergency.

These BARDA and the Ministry of Defense Joint Project Executive Office's efforts aim to use part of the funds provided by Congress for the COVID-19 response to increase the production capacity of domestic supplies of consumables required for the vaccine manufacturing process
.

The epidemic has caused a nearly three-fold increase in vaccine demand, straining the industry’s ability to produce disposable system components that are widely used in the manufacture of vaccines, monoclonal antibodies, and other biological products (including cell and gene therapy), and triggering a wide range of related issues.

Together with BARDA’s incentives, the US FDA is developing guidelines to simplify the regulatory procedures that pharmaceutical manufacturers must follow to switch to alternative suppliers
.

[FDA will issue new guidelines to deal with the shortage of production components on October 07, 2021]

Seek proposals for factory expansion

Seek proposals for factory expansion

BARDA expects that the expansion of production capacity will be completed within two years, despite the "extreme need for faster and accelerated expansion
.

" After the expansion is completed, the factory will receive a 10-year subscription period, priority pricing and priority purchase orders from BARDA and third parties authorized by BARDA

BARDA plans to expand its production capacity by November 2022 to produce:

The number of customizable disposable piping components has increased from 4,000 pieces per month to 12,000 pieces per month;

The number of disposable pumps increased from 100 per year to 400 per year;

The single-use mixing system increased from 24 per year to 120 per year;

The aseptic individual packaging components have been increased from 1,000 pieces per month to 10,000 pieces per month
.

The deadline for proposal responses is October 22
.

FlexBiosys contract

FlexBiosys contract

FlexBiosys' contract stems from BARDA's call for the expansion and acceleration of new crown drug consumables on July 8.
The focus is to increase the supply of disposable bags and pipes, hoses, filters and bottle components
.

The capacity expansion is to increase the supply of BARDA-funded COVID-19 vaccine developers by 2023

FlexBiosys' single-use bag production capacity will increase from the initial 20,000 per year to 650,000 in March 2022
.

At the same time, the pipeline output will increase from zero to 1.

Other new crown related contracts

As the 2021 fiscal year ends at the end of September, the US federal government has announced more new crown-related contracts
.

BARDA’s parent organization, the Office of the Assistant Secretary for Preparation and Response (ASPR) stated on September 28 that it intends to order Temptale 4 Bio cold chain temperature monitors from Sensitech from a single source

In addition, BARDA awarded Monogram Biosciences, a company located in South San Francisco, California, a contract worth US$10.
5 million on October 1 to provide counterfeit virus neutralization laboratory analysis and detection capabilities, and to evaluate emerging

Medical countermeasures for SARS-CoV-2 variants
.

The contract will involve the production and use of SARS-CoV-2 pseudotyped lentivirus

The National Academy of Sciences, Engineering, and Medical Sciences will support a medical and public health preparedness forum on disasters and emergencies under a contract of no more than $200,000
.

The forum will have four thematic areas: global health security, individual and community resilience, critical infrastructure needs, and communication and coordination
.