Collaboration includes build of embedded process and analytical development labs for use by Mayo Clinic and third-party biotech companies to advance cell therapies to clinical trials.
National Resilience, Inc. (Resilience), a technology-focused manufacturing company dedicated to broadening access to complex medicines, today announced a strategic collaboration with Mayo Clinic in biomanufacturing to deliver novel biotherapeutics for rare and complex conditions. The focus will be on therapies derived from biologics — cells, blood, enzymes, tissues, genes, or genetically engineered cells — for use in medicines.
Resilience will collaborate with Mayo’s Center for Regenerative Medicine in Two Discovery Square, located within the research corridor of the Destination Medical Center economic development initiative in Rochester, Minnesota. Resilience and Mayo will build embedded process and analytical development labs, as well as quality control labs. This “embedded” approach allows for closer proximity and collaboration to jointly develop and progress cell therapies and other advanced modalities into clinical care. The collaboration also aims to attract third-party biotech companies interested in sponsoring clinical trials for new therapeutics, as well as collaborating on their process and analytical development.
In addition, the collaboration seeks to advance biologic discoveries toward early stage clinical trials.
“By combining our organizations’ capabilities in biomanufacturing and medical innovation, we have an opportunity to deliver complex and innovative therapeutics to patients in need,” said Rahul Singhvi, ScD, Chief Executive Officer of Resilience. “We are delighted to continue to grow our presence across North America, as our collaboration with Mayo Clinic will establish Rochester, Minn., as a center of excellence for biomanufacturing cell and regenerative technologies.”
The collaboration will also allow Mayo to leverage Resilience’s broad network of offerings. Resilience currently has 11 facilities across North America, with more than 1 million square feet of manufacturing space. The company’s network, which is expected to add capacity and capabilities this year with projects underway at several existing sites across all modalities, is agile enough to scale customer projects from process and analytical development through preclinical, clinical, and to large scale commercial manufacturing.
The collaboration focuses on the following initiatives:
- Process and Analytical development
- Biomanufacturing for early-stage cell and gene therapeutics
- Analytical testing and quality control required for manufacturing commercial-grade biopharmaceuticals
- A business incubator where healthcare entrepreneurs, startups, and industry experts can work together on forwarding breakthrough technologies to market
- Access to clinical trial capabilities and patients