Evotec SE’s Seattle-based subsidiary, Just – Evotec Biologics, Inc., has been selected by the U.S. Department of Defense (DOD) to develop an accelerated monoclonal antibody (mAb) development and manufacturing solution for the DOD’s Manufacturing Optimization Program.
 
The multi-year program award, valued up to $39 million, will support the U.S. Government’s effort to enhance its rapid response capabilities for biologics medical countermeasures (MCMs).
 
Under the program, Just – Evotec Biologics will focus its expertise on project activities and technologies that will significantly decrease the time for development, manufacturing, and CMC-focused regulatory efforts. These innovations will significantly increase the speed to first clinical doses while maintaining high mAb quality, productivity, and safety criteria.
 
Activities include developing and testing process development optimization, improving efficiencies in cGMP manufacturing and drug product release, and enhancing operational and resource workflows. The program will culminate in testing the optimized system components through rapid response exercises, starting with a DOD-identified MCM antibody sequence, and ending with the manufacturing of clinical doses.
 
The Just – Evotec Biologics’ optimized manufacturing solution will seamlessly integrate into the U.S. Government’s rapid emergency response system spanning the entire drug development lifecycle, with an overall 100-calendar day target timeline for advancing drug development from pathogen identification through fielding of doses.
 
Dr Linda Zuckerman, Executive Vice President Global Head Biotherapeutics at Just – Evotec Biologics stated: “We are proud to be selected to provide our expertise and technologies in support of this important program. We are excited to push our current end-to-end biologics development platform and partner with the DOD to bring ‘next level’ development of fast, high quality, cost efficient mAbs to the clinic.”
 
Prior contracts awarded to Just – Evotec Biologics by the DOD include the COVID project, which enabled the manufacture of doses under tight timelines and restricted resourcing, and Accelerated Antibodies, which focuses on mAb prophylactic therapies for Plague and Orthopoxviruses.