National Resilience, Inc. has taken a major step to further its goal of making the country’s domestic pharmaceutical manufacturing capacity more resilient to future pandemics.
On Nov. 29, Resilience announced it had entered into a long-term biomanufacturing agreement with pharmaceutical giant AstraZeneca (AZ) that includes Resilience purchasing and operating AZ’s manufacturing facility in West Chester, Ohio. Resilience will manufacture select AZ medicines at the facility as part of the agreement.
The West Chester site is a commercial-scale, 580,000-square-foot facility with a record of regulatory and commercial drug supply performance in numerous global markets. The site is equipped with end-to-end drug product manufacturing capabilities, including aseptic filling, inspection, packaging, labeling, and cold-chain operations for vials, cartridges, pre-filled syringes, and autoinjectors, as well as a virtual reality training center.
“We envision the West Chester site as our global center of excellence for commercial drug product manufacturing that will produce a wide range of life-saving medicines,” said Resilience CEO Rahul Singhvi. “This partnership is an exciting step toward our mission of broadening patient access to complex medicines and protecting domestic biopharmaceutical supply chains.”
Completing the Network
San Diego-based Resilience was founded after the COVD pandemic exposed weakness in the U.S.’s domestic ability to supply vaccines needed to fight the pandemic. Since its founding, the company has furthered its goal of shoring up domestic drug manufacturing capability by raising over a billion dollars, signing multiple strategic partnerships and purchasing or developing several drug manufacturing facilities.
West Chester is Resilience’s first drug product facility in its network, giving the company the ability to put finished drugs in their final containers like vials, syringes or cartridges.
“It is extraordinarily important that these drugs are produced in a facility that has very high-quality training and very high-quality skills because most of this work is done under sterile, aseptic conditions, Singhvi said. “Having a group of people who have been doing this for years and in a facility that is making licensed products that are globally distributed and have been inspected by multiple regulatory authorities around the world is an incredible, important capability. Now that we have this end-to-end network, we feel very strongly that we can make all kinds of vaccines and supply for this country.”
500 New Employees
As part of the deal with AstraZeneca, Resilience is retaining all 500 employees of the facility. One of the reasons AZ struck the deal to sell its West Chester site is that the space has been underutilized.
“The transfer of our West Chester site to Resilience will enable the continued supply of AstraZeneca medicines to patients, as well as the continued employment for more than 500 people working at the West Chester site. I’m encouraged by Resilience’s plans to transform the site into their drug product center of excellence,” said Andrew Wirths, senior vice president, Americas Supply Region, AstraZeneca. “As part of our long-term strategy to ensure our global supply network remains fit for the future, we are continuously optimizing our manufacturing footprint to meet the evolving needs of our pipeline and portfolio.”
After a recent meeting with the new employees, Singhvi said he was excited about the skill set they bring to Resilience, and they were excited about the prospect of more work.
“That’s the promise we bring for this group,” he said. “We are going to be scouring the world and bring work for them – and they all want to be busy. It was a great equation there.”
The new employees were also excited about Resilience’s mission.
“Resilience is a company of the future. This is a company that our children will be thankful of for driving the changes necessary to make sure we have access and affordability of important medicines, and that resonates with the people there,” Singhvi said.
AZ Accesses New Capabilities
For AZ, the great equation of the deal is that in addition to adding efficiency by letting go of unused space, it will also now have access to Resilience’s nearly two million square feet of end-to-end drug capacity and solutions for the process and analytical development and GMP biomanufacturing of biologics, vaccines, nucleic acid, cell therapy, and gene therapy modalities.
“We have capabilities in the front end, what they call drug substance, for a number of the newer medicines coming in,” Singhvi said. “Many of these companies have not caught up yet to all these newer modalities and we are able to provide them that service right away.”
Although the financial details of the deal were not made public, the two companies anticipate completing the transaction in early 2023, subject to receipt of regulatory approvals and the satisfaction of other customary closing conditions. Upon closing, Resilience will acquire the West Chester site’s operations and physical assets, retain the site’s leadership and employees, and continue to invest in the workforce and facility.
“it’s a massive site. It’s huge, so we can make a lot of different types of drugs there and so it can accommodate a lot more than 500 people,” Singhvi said.
National Resilience, Inc.
CEO: Rahul Singhvi
Headquarters: San Diego
Notable: In two years, Resilience has acquired or built nearly 2 million square feet of manufacturing capacity.