Resilience Government Services, Inc.

The same day that National Resilience announced a new CEO, it said that it will cut more than 100 jobs in Florida. The company on Thursday disclosed a mass layoff in the state, saying that 105 employees would be let go from a site in Alachua, FL, according to a WARN report. A spokesperson for the company said it “made the decision to downsize our government business to focus more strategically on commercial development and manufacturing to meet customers’ demands and patients’ needs.” “We are managing resources in our sites based on customer demand, which requires reducing headcount in parts of our network while simultaneously growing it in other parts,” the spokesperson said. Resilience added in its disclosure that the site is not closing. The Alachua campus is a hub for biologics and vaccine development, with more than 150,000 square feet spread across multiple facilities. It’s a Department of Defense Advanced Development and Manufacturing (DoD-ADM) facility and was originally owned and operated by Ology Bioservices. Resilience bought Ology in April 2021, taking over the company’s work with the government. As part of the original arrangement, the contractor owned the land and the exterior buildings, but all interior infrastructure was owned by the DOD. But in the government’s fiscal 2022, it sold its share to Resilience, maintaining priority access. Changes are afoot at National Resilience, including a CEO swap earlier this week . President and COO William Marth has taken the helm, replacing Rahul Singhvi. And it has been making cuts in some parts of the business while growing elsewhere. In early 2023, the manufacturer cut most of its staff at a Massachusetts facility. In December of that year, more layoffs were made to its technical R&D and quality assurance divisions. Earlier this year, the company poured $225 million into a Cincinnati site and announced plans to expand in North Carolina.

The funding will enable Aralez Bio to enhance cGMP production capabilities by leveraging an advanced technology. Credit: National Resilience/Business Wire. National Resilience’s subsidiary Resilience Government Services has received around $17.5m in funding for expanding critical medicine components manufacturing. Resilience received the funding from the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response’s Center for Industrial Base Management and Supply Chain. This funding will be used for domestic pharmaceutical manufacturing expansion, enhancing the production of essential medicine components. It will help secure the supply chain for key starting materials and active pharmaceutical ingredients (APIs). The financial injection is part of a collaboration with the public-private partnership, Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium), focused on strengthening the domestic biomanufacturing sector for medical countermeasures. Resilience has joined forces with Aralez Bio, a biotech company specialising in advanced amino acids production, to utilise biocatalysis technology. See Also: Advancing Pharmaceutical Security: The Role of SECURtracers in On-Dose Authentication Healthcare Payers for the Pharmaceutical Industry Under the agreement, Resilience will employ its certified good manufacturing process (cGMP) facilities, analytical development, and regulatory expertise to reinforce the pharmaceutical supply chain. Resilience CEO Rahul Singhvi said: “Securing this manufacturing programme for Resilience is a good step forward for the US pharmaceutical manufacturing industry to ensure a more resilient and responsive supply chain. “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.” This initiative is crucial for ensuring the continuous availability of life-saving medications that are currently in short supply. It aligns with the BioMaP-Consortium’s goal to bridge the gaps in pharmaceutical manufacturing via public-private partnerships. The funding will facilitate cGMP manufacturing with Aralez Bio’s advanced technology, aiming to streamline API production processes in the US and meet the Food and Drug Administration’s requirements for Resilience to become an approved domestic supplier of APIs. Aralez Bio CEO Tina Boville said: “Aralez Bio’s proprietary enzyme platform is at the forefront of amino acid chemistry. When combined with Resilience’s groundbreaking approach to revolutionising pharmaceutical manufacturing, this collaboration is strengthening the security of our supply chains.” In March 2023, National Resilience secured a $410m long-term loan financing deal to establish an end-to-end biomanufacturing capacity.

bluebird bio and National Resilience signed a strategic alliance around cell therapies. As part of the deal, Resilience is buying bluebird’s manufacturing facility in Research Triangle Park, keeping more than 100 staffers. bluebird bio and National Resilience signed a strategic alliance around cell therapies. As part of the deal, Resilience is buying bluebird’s manufacturing facility in Research Triangle Park, keeping more than 100 staffers. Resilience will also continue supplying gene and cell therapy vectors for bluebird bio and 2seventy bio, bluebird’s oncology cell therapy spinoff that is expected to launch by the end of the year. National is paying bluebird $110 million for the acquisition. They expect to continue collaborating on the next stage of 2seventy’s pipeline. The Durham, North Carolina facility is 125,000 square feet and manufactures lentiviral vector (LVV). The plant also had production suites for drug substances and drugs, as well as quality control laboratories and warehouse space. There is room to grow. Once this deal is wrapped, the Resilience network will include 10 locations in North America, totaling more than 1 million square feet of space devoted to manufacturing, development and support. National Resilience launched in November 2020 with $800 million in funds from venture capital firms. Investors included ARCH Venture Partners, 8VC and others. It specializes in biopharma manufacturing. Since then it has acquired a former Sanofi-Genzyme site in Boston and another in Mississauga, Ontario, Canada. Then in May 2021, it bought Ology Bioservices, an Alachua, Florida-based biologic drug substance manufacturing company. Also in May, the company announced that the government of Canada had invested $163.8 million (U.S.) through the Strategic Innovation Fund into Resilience’s Ontario subsidiary Resilience Biotechnologies. “Resilience was founded during the pandemic to build a better system for manufacturing complex medicines to fight deadly diseases,” said Rahul Singhvi, Resilience’s chief executive officer, at the time of the Canadian announcement. “This partnership with the government of Canada will help prepare Canada for future pandemics and strengthen the country’s biopharmaceutical ecosystem.” Bluebird’s spinoff was announced in January 2021, with plans for it to focus on cancer while retaining its focus on severe genetic diseases. Nick Leschly will run 2seventy bio while Andrew Obenshain will act as chief executive officer of bluebird bio. “Our mission of developing the next generation of cell therapies requires a thoughtful balance of innovation from both a scientific, medical and regulatory perspective as well as manufacturing perspective,” Leschly said. “We believe Resilience is an optimal partner to help us achieve this mission as well as the ideal successor for the next phase of the bRT (bluebird Research Triangle) facility’s growth. As we continue to pivot toward the planned separation of bluebird and 2seventy, this strategic partnership allows us to share risk, streamline our business operations, provide additional capital and importantly ensures uninterrupted access to vector supply as we develop additional transformative treatments.” Last week, July 21, bluebird announced that the European Commission granted marketing authorization to Skysona (elivaldogene autotemcel, Lenti-D), its one-time therapy for early cerebral adrenoleukodystrophy (CALD) in patients younger than 18 years with an ABCD1 genetic mutation who do not have a human leukocyte antigen (HLA)-matched sibling hematopoietic stem cell (HSC) donor. CALD is a rare neurodegenerative disease that can lead to irreversible loss of neurologic function and death.