Umoja’s VivoVec Development and Manufacturing Facility
Our state-of-the-art development and manufacturing capabilities leverage our proprietary expertise and enable the flexibility and adaptability needed for clinical drug product production.
Expertise in cell+gene manufacturing
Development and manufacturing are core competencies of Umoja, which ensures that our treatments are widely accessible and cost-effective.
Led by Ryan Crisman, Umoja’s Co-founder and Chief Technology Officer, Umoja is pioneering best-in-class development and manufacturing capabilities. Ryan is joined by Senior Vice President of Process and Product Development, Bruce Kerwin, an industry leader in drug product design who brings 30 years of experience in the biotechnology field, and Sally Dyer, as General Manager for Colorado Operations who has 27 years of industry experience, including multiple facility start-ups for commercial manufacturing using new technologies. Rounding out the team is a cadre of experienced scientists and engineers with backgrounds from companies such as Amgen, Novartis, the Bill and Melinda Gates Foundation, Bristol Myers Squibb, and Novozymes.
Together, they’ve supported and helped bring an array of successful drugs to the market, such as Imlygic®, Zolgensma®, Epogen®, Aranesp®, Prolia®, Siliq®, Breyanzi®, and Nplate®. Thanks to their expertise, Umoja is able to reduce costs, streamline production, and efficiently deliver our treatments to patients who cannot afford to wait.
The Colorado Laboratory, Innovation and Manufacturing Building
In August 2021, Umoja broke ground on our state-of-the-art lentiviral vector development and manufacturing facility, The CLIMB in Louisville, Colorado. Designed to initially support viral vector development and production for clinical studies through Phase 2, the 146,000 square-foot facility will enhance Umoja’s vector manufacturing, process and analytical development, and drug product production capabilities.
By bringing development and manufacturing in house, we are able to continuously improve our manufacturing platform while increasing the quality of our lentiviral vector product.
Additionally, in-house development and manufacturing allows Umoja to de-risk the supply chain while providing flexibility and adaptability over our lentiviral production for in vivo therapy. Our suspension-based process provides for fast First-in-human (FIH) studies and expansion to large-scale commercial production. Transient transfection can be used in the process, with the stable producer cell line technology also providing for enhanced scalability and strategic partnering opportunities with large-scale vector production.
Groundbreaking at Umoja’s cGMP-grade manufacturing facility, The CLIMB in Louisville, CO took place in 2021 and construction is expected to be completed and the facility fully-on line for production of clinical-grade supply in early 2023.