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20-Feb-2024

Resilience Expands Clinical and Commercial Drug Product Manufacturing Capabilities and Capacities

$225 million to be invested into Cincinnati facility to increase PFS and Cartridge fill/finish capabilities

Expanding Research Triangle Park (RTP) fill/finish operations, building on company’s existing fill/finish capabilities in Toronto and Cincinnati

Capacity across Resilience network to scale to over 200 million units by 2025, supporting existing and new partners across Pharma and Biotech portfolio

SAN DIEGO--(BUSINESS WIRE)--National Resilience, Inc. (Resilience), a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, today announced the expansion of the company’s clinical and commercial drug product manufacturing capabilities across its network. By scaling this capacity, Resilience aims to provide over 200 million units to its partners across its manufacturing network by 2025 in support of multiple modalities and therapeutic indications, including GLP-1.



Resilience’s pre-clinical, clinical and commercial cGMP manufacturing network was built to help withstand unforeseen difficulties like capacity constraints, raw material supply chain shortages and disruptions. This expansion addresses the biomanufacturing industry’s growing demands within the drug product space, further responding to industry needs.

In Cincinnati, at least $225 million is planned to be invested to increase the site’s drug product capacity. The FDA-licensed site currently has three high speed fill lines for Vials, Cartridges and pre-filled syringes (PFS), with a fourth PFS fill line ready by 2025. The facility is also expanding to six device assembly and packaging suites by 2025 to meet the industry’s growing biomanufacturing demands. The licensed site has a longstanding history of supplying commercial medicines worldwide.

Additionally, Resilience is expanding its drug product capabilities at the company’s RTP facility in North Carolina using a modular design within its segregated expansion space to offer drug product manufacturing for multiple modalities. The site has drug substance and drug product experience in support of Gene Therapy medicines. It also has 45,000 square feet of grey space available for additional expansion that will be leveraged for drug product operations. As part of the growth plans, a new state-of-the-art Bausch & Strobel Isolator filler will be installed to support Vials and PFS, providing flexibility and quality assurance with its barrier isolation technology.

“Strengthening our drug product manufacturing capacity across the Resilience network highlights our commitment to providing robust and scalable outsourcing options for our partners,” said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. “As a highly experienced team already supporting a leading pharmaceutical company with their GLP-1 products, this expansion further supports Resilience’s mission to ensure adequate biomanufacturing capacity by addressing and overcoming historic manufacturing challenges throughout the industry.”

Forward-Looking Statements

This press release contains express or implied forward-looking statements that are based on the beliefs and assumptions of, and information currently available to, company management. All statements other than statements of historical fact are forward-looking statements, including, but not limited to, statements regarding our expected plans for expansion and future production capacity. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements involve known and unknown risks, uncertainties and other factors, in some cases, which are beyond our control, that may cause our actual performance or achievements to be materially different from any performance or achievements expressed or implied by these forward-looking statements. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those implied or projected by the forward-looking statements.

These forward-looking statements relate only to events as of the date of this press release. Resilience undertakes no obligation to update any forward-looking statements made in this press release to reflect events or circumstances after the date of this press release or to reflect new information, actual results, revised expectations, or the occurrence of unanticipated events, except as required by law.

About Resilience

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at-scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives and protect biopharmaceutical supply chains against future disruptions. For more information, visit https://resilience.com/ and follow us on social media: @IncResilience on X and Resilience on LinkedIn.

If you need support on a project, please contact us at https://resilience.com/connect/.


Contacts

Michele Roberts
Head of Communications
Michele.roberts@Resilience.com
(888) 737-2460

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Last Updated: 20-Feb-2024