SAN DIEGO: #CCO--National Resilience, Inc., a technology-focused biomanufacturing company dedicated to broadening access to complex medicines, proudly announces that its subsidiary, Resilience Government Services, Inc., has been awarded nearly $17.5 million in new funding from the Administration for Strategic Preparedness and Response’s (ASPR) Center for Industrial Base Management and Supply Chain (IBMSC), part of the U.S. Department of Health and Human Services, to support the domestic production of key starting materials and active pharmaceutical ingredients for essential medicines.

This funding is a result of a project agreement with the Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), a public-private partnership established in January 2024 to help expand the domestic industrial and biomanufacturing base for medical countermeasures by leveraging the capabilities of industry partners across the drug manufacturing supply chain. Under the agreement, Resilience has partnered with Aralez Bio, a biotechnology company creating next-generation amino acids through an advanced proprietary platform technology harnessing the power of biocatalysis. As part of this agreement, Resilience will leverage its current Good Manufacturing Process (cGMP) manufacturing infrastructure, analytical development expertise, and regulatory and quality experience to fortify the pharmaceutical supply chain and enhance production of the nation’s critical medicines. This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Office of Industrial Base Management and Supply Chain (IBMSC), under OT number #75A50123D00003.

This effort helps to ensure the availability of life-saving medicines currently in drug shortage and supports the BioMaP-Consortium's mission and commitment to addressing critical gaps in pharmaceutical manufacturing through public-private partnerships. The funding will enable cGMP manufacturing using Aralez Bio’s cutting-edge technology platform to streamline production processes for active pharmaceutical ingredients made within the United States, including submitting the necessary data to the U. S. Food and Drug Administration for Resilience to become an approved domestic Active Pharmaceutical Ingredient (API) supplier for pharmaceutical manufacturers.

“Securing this manufacturing program for Resilience is a good step forward for the U.S. pharmaceutical manufacturing industry to ensure a more resilient and responsive supply chain,” said Rahul Singhvi, ScD., Chief Executive Officer at Resilience. “With the support from both public and private sectors, we are positioned to enhance and expand domestic production of key starting materials and active pharmaceutical ingredients that often fall into short supply.”

“Aralez Bio’s proprietary enzyme platform is at the forefront of amino acid chemistry. When combined with Resilience’s groundbreaking approach to revolutionizing pharmaceutical manufacturing, this collaboration is strengthening the security of our supply chains,” stated Tina Boville, PhD, Chief Executive Officer of Aralez Bio. “We are excited to partner with Resilience and contribute to the renewal of the domestic bioeconomy.” This announcement represents the dedication of private and public industry leaders to delivering essential pharmaceutical ingredients to meet domestic healthcare needs.

About National Resilience, Inc.:

National Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines (biologics, vaccines, nucleic acid, cell and gene therapy modalities and drug product). 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, National 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 resilience.com/ and follow us: Resilience on LinkedIn.

About Aralez Bio:

Aralez Bio is an emerging leader in the enzymatic synthesis of noncanonical amino acids (ncAAs). The company has invented an enzymatic platform for synthesizing complex amino acids, enabling clients to access amino acids that are needed for innovations in pharmaceuticals, agriculture, and functional materials. Compared to traditional approaches, the company’s enzymatic processes take less time, generate less waste, and make a purer amino acid product. Today Aralez Bio’s ncAA library is the largest in the world and growing. For more information, visit https://aralezbio.com/ and follow us on social media: @AralezBio on X and Aralez Bio on LinkedIn.

Fonte: Business Wire