National Resilience, Inc. (Resilience), Expands Clinical and Commercial Drug Product Manufacturing Capabilities and CapacitiesNational Resilience, Inc. , 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.”
